RFI Comments - Format

Basic Science, Format

  • General CommentsI recommend: (i) consolidation of NIDA’s priorities to a reduced number of themes (~3) and goals (<10); and (ii) re-writing the priorities to enable an investigator to clearly understand their direction and intent. This will enable investigators to understand NIDA’s priorities and research directions, and will provide some direction as to what the expected outcomes are. The NIDA strategic plan has a very large list of priorities that covers diverse topics. Many of the individual components were poorly defined, which made it difficult to identify the key areas of focus and the goals that NIDA wants to achieve. For example, the basic science priorities alone had 12 of topics across a diffuse set of objectives, which ranged from cellular and animal models to evaluating the impact of mental health on addiction. I do not know why “evaluating the impact of mental health and HIV/HCV infection on addiction,” which is an epidemiological undertaking, is a component of basic neuroscience. The priorities are listed under 5 different themes, which further compounds the problem of having so many priorities. The diffuse and unclear description of many of the priorities adds to the numerical problem. For example, “Integrating animal models, behavior, genetics, epigenetics, and other molecular biomarkers for drug abuse and addiction” is a priority. Does this mean that NIDA wants to better understand drug abuse and addiction through the integrated analysis of data obtained from various sources? If so, it is important to specify what we hope to learn. Similarly, I was unable to interpret what was desired from the priority “Neural-glial, -immune, and neuroendocrine interactions.” Two different priorities ((i) Increase our knowledge of biological, behavioral, environmental, and developmental factors involved in risk and resilience for drug use and addiction and (ii) Improve our understanding of the interaction between addiction and co-occurring conditions) are probably the same. It is very difficult to do contribute progress metrics for a priority that begins with “increase our knowledge of” or “improve our understanding of.”  Specific CommentsI believe that NIDA should prioritize funding research that will uncover fundamental mechanisms of neurodevelopment, factors affecting drug addiction, and the characterization of the interaction between environmental and genetic factors affecting drug addiction. These are very difficult areas to study in human populations; it is difficult to obtain samples from relevant tissues, and there are multiple confounding variables that cannot be controlled in human populations. However, there is now a huge opportunity to obtain new knowledge in these areas from analysis of mouse genetic models, and this could generate new therapeutic approaches to address the growing health problem caused by drug addiction. To do this, the findings from the mouse models must be coupled with two other areas: (1) functional analysis of pathways and (2) human translational studies. New methods for analysis of mouse genetic models can now be used to identify the underlying genetic factors. However, analysis of these models requires a different approach than those that were developed in the 20th century, when studies analyzed a very limited amount of genetic limited diversity present in intercross or recombinant inbred strains. Moreover, they analyzed SNP markers, which did not encompass all of the information about the pattern of genetic variation in the mouse genome.  In contrast, 21st century methods require analysis of many inbred strains, which enables the strains with outlier phenotypes to be identified (i.e. the strains that represent susceptible and resistant populations). In addition, the analyses should use full genomic sequence data; and the use of integrated datasets. Thus, I believe that NIDA should prioritize funding for the following 3 areas:The development of mouse genetic models of the behaviors/responses that are key to NIDA’s mission, which is identify the genetic underpinnings that lead to addictive behaviors. Of particular importance, the endophenotypes that contribute to addictive behavior can be modeled under conditions where the environmental variables can be controlled (and the effect of environmental factors can be analyzed). This includes funding the analysis of the models developed across a large panel of inbred strains, which will enable them to be successfully genetically analyzed. To do this, teams of investigators should be formed, which will include those that develop the models and those able to analyze the models.This should be accompanied by funding of experimental analyses of the pathways identified by the genetic analyses in mice. This step is critical for understanding the effector mechanisms, which will enable human translation; and possibly the generation of new therapeutic approaches. The analysis of genetic factors affecting addiction often requires in vivo models. Thus, funding methods that use new methods for mouse genome engineering is critical for this, since it will enable the effect of allelic differences to be assessed.The 3rd component is funding for human translational studies. The 20th century concept of performing GWAS using SNP allele markers on existing arrays must be discarded for analysis of human cohorts. In contrast, targeted analysis of candidate regions using sequence is needed.

Format, Basic Science, Clinical and Translational Science, Infrastructure

  • Background The mission of NIDA is to lead the nation in bringing the power of science to bear on drug abuse and addiction. NIDA fulfills this mission by supporting research to prevent and treat drug abuse and addiction and mitigate the impact of their consequences, including the spread of HIV/AIDS and other infectious diseases. NIDA-supported programs span basic, clinical, and translational sciences and incorporate genetics, epigenetics, neuroimaging (functional, biochemical, structural), social neuroscience, medication and behavioral therapy development, as well as prevention and health services research.The current NIDA Strategic Plan was published in 2010. Since that time, there have been major advances in the science of drug abuse and addiction. Therefore the Institute has begun a planning process to develop a revitalized Strategic Plan for 2016–2020. NIDA seeks to harness the latest research technologies and apply them to the ever-evolving substance abuse landscape. Toward this goal, NIDA staff developed a draft set of strategic priorities and are seeking feedback to guide the development of NIDA’s Strategic Plan.Information RequestedThis RFI is intended to gather broad public input on the draft strategic priorities outlined below as well as general recommendations that will sustain recent advances and accelerate discovery in addiction research over the next five years. NIDA invites input from researchers in academia and industry, health care professionals, patient advocates and advocacy organizations, scientific or professional organizations, federal agencies, and other interested members of the public. Organizations are encouraged to submit a single response that reflects the views of their organization and membership as a whole.Please provide your perspective on the following items as they relate to the draft strategic priorities outlined below. Your comments can include, but are not limited to:  Suggested changes or additions to the list of strategic priorities, including   emerging research needs and future opportunities that should be considered in   the plan   The scientific rationale for the changes or ideas proposed and the anticipated   impact on advancing the science of drug abuse and addiction   Anticipated challenges that will need to be addressed to achieve these   priorities   Appropriate benchmarks for gauging progress toward each recommended priority   Recommended measurable objectives associated with an individual priority NIDA also welcomes your general comments, including those regarding the extent to which this plan will guide and encourage participation in drug abuse research.Draft Strategic Priorities (A general comment is these objectives are almost too broad and too general to be meaningful – in an industrial setting they would be rejected as likely to unachievable no matter how many teams of researchers you “throw” at them.   So I have made some track changes I hope are helpful to the NIDA team.) ed note: changes are incorporated, comments are parenthetical.Basic Neuroscience: Continue to increase the preclinical database concerning drug use, vulnerability to addiction, withdrawal, relapse and recovery.  with focus on biological, behavioral, environmental, and   developmental factors involved in risk for drug use and   addiction and the factors influencing resilience and recovery   This requires: 1)Integrating the preclinical data base across behavioral genetic, epigenetic and potential molecular biomarkers of drug use, abuse and addiction.    2) Continuing to determine the developmental trajectory of addiction  (Since these studies in the preclinical setting are done in the absence of a social environment, not likely to yield directly translatable information.  I might omit this particular sentence and stick to vulnerability of developing brain to addiction and determining which drug class is preferred at various  developmental stages)  3) Continuing to delineate the brain circuits related to drug abuse and   addiction at the cellular, circuit, and connectome levels, which includes:: Normal development and function across the lifespan including mechanisms of   reward, self-control, and conditioning The effects of drugs of dependence on neuroplasticity, neural structure, and circuit function from acquisition/use to addiction/dependence, through to withdrawal and recovery.     Neural-glial, -immune, and neuroendocrine interactions as applicable to the studies above.   Defining the interactions between addiction and pain, including   molecular, genetic, behavioral , and neural-circuit-related factors, to guide   the development of alternate treatment strategies for pain patients (Is this not better served by a cross institute approach as only focusing on the interaction between addiction and pain may miss important intervention opportunities for pain in general)  3) Continuing to elucidate the significant determinants of addiction in those with comorbid conditions (eg.psychiatric, HIV, HCV, pain).     And the converse to determine the impact of addiction on the underlying diseases such as whether the molecular mechanisms of latent HIV reservoirs in the brains of SUDindividuals differ from those without SUD Clinical and Translational Science: Support (Support is a weak term – how about Direct resources toward the development?) the development of new and better interventions including preventative and treatments  for SUDs. To fulfil this objective resources will be allocated as follows:  Support the development of novel, evidence-based (If they are novel it is hard to have a clinical evidence base yet – just using buzz words?), targeted prevention and   treatment interventions including social, behavioral, pharmacological,   vaccines, and brain stimulation therapies (e.g., transcranial magnetic   stimulation, direct current stimulation, etc.) Target the introduction of novel prevention and treatment interventions that may be social, behavioral, pharmacologic (including vaccines)or devices (transcranial magnetic stimulation as an example)Identify the most promising targets and or ligands to assiste in new drug discovery and developmentCollaborate in the effort to accelerate medications development for SUDFocus this development on SUD with no known pharmacologic treatment for either dependence, toxicity, withdrawal or agents to hasten neurobiologic recoveryTarget treatments for SUD plus comorbidities (HIV,pain as examples)  Develop techniques to measure and improve patient compliance in clinical   trials (This should be a cross agency endeavor if limited to addiction may result in tailored but not generalizable data/techniques – I would develop the techniques broadly then apply to SUD)2)  Describe and quantify measurable outcomes beyond abstinence that can be used in clinical trials/clinical assessment of SUD.  These outcomes could include biomarkers of addiction, withdrawal, relapse risk or sustained relapse.   Public Health: Increase the public health impact of NIDA research and programsImprove the understanding of factors that influence the integration of   evidence-based research findings into healthcare policy and practice   (implementation science) Increase readiness to respond to emerging public health priorities (opioid   overdose epidemic, potential consequences of marijuana legalization, changing   healthcare landscape, emerging drug trends, etc.) Increase strategic partnerships with the community (academia, PhRMA or pharmaceutical companies, biotechnology companies,   healthcare organizations, policy makers, etc.) to enhance the dissemination of   evidence-based research findings into policy and practice Strengthen the focus on bi-directional translational research Science Infrastructure: Enhance the national research infrastructure to support advancements in science 1) Accelerate the development and utilization of advanced technologies (e.g. the   President’s BRAIN Initiative), data repositories (e.g. Big Data to Knowledge   (BD2K) initiative, and statistical models to spur innovative research  2) Improve training for the next generation of scientists  3) Increase effective engagement and training in multidisciplinary research   (informatics, engineering, computer science, chemistry, mathematics, physics,   etc.)  4) Increase the number of well-trained underrepresented scientists in the drug   abuse and addiction field at all career levels because this ensures diversity in scientific discovery and the inclusion of the needs of diverse populations  5)Improve mentoring of young scientists and junior faculty 6) Increase effective collaborations in research (All research or specific to SUD?/mission)  7)Increase the transparency of research performed by grantees and within NIDA 8) Increase effective data and resource sharing (big data (More buzzwords of the moment – but big data means: mining data from insurers, large care providing institutions and available data from pharmaceutical companies??), biorepositories,   transgenic/optogenetic tools (Sharing resources developed by grantees, such as optogenetic tools), data standards, etc.)  9) Increase collaborations with other NIH Institutes and Centers (e.g.   Collaborative Research on Addiction at NIH (CRAN)), Federal and State   agencies, academic and industry partners, etc.( We try to avoid etc in industry – people interested in how their money is spent don’t like it much)  10) Identify and implement strategies to improve the reproducibility of   pre-clinical research(This is probably the most important statement in the document but belongs with transparency and should be the highlighted rationale for transparency – you can even comment on it under drug development)  11)Enable efficiency and lower the cost of clinical trials via innovative   statisticalmethods such as adapative design, helping to establish SUD data collection and reporting standards, leveraging technology (e.g. electronic   health records) and developing partnerships  12)Develop and validate computational and systems-level analytics for integrating   multi-dimensional data across the addiction trajectory(And in reality this means?) Unifying themes: A number of unifying themes that will be addressed across each of the domains listed above include:  Promoting research that considers the impact of sex and gender on drug abuse   and addiction   Addressing health disparities among underrepresented populations   Understanding the role of development across the life span   Addressing the treatment needs of adolescents and pregnant and post-partum   women (For what it is worth first time mentioned in whole document)   Addressing the treatment and prevention needs related to common co-morbidities   including HIV/AIDS

Format, Basic Science, Public Health, Clinical and Translational Science, Unifying Themes, Infrastructure

  • On behalf of the American Psychiatric Association (APA), the medical specialty association representing 36,000 psychiatrists and their patients and families, I am pleased to share APA’s comments on the National Institute on Drug Abuse’s draft strategic plan. We would like to commend NIDA on developing a well-organized draft that is thoughtful, comprehensive, impactful and wide-reaching in its scope. Our feedback on the draft strategic priorities reflects our great concern about the impact of substance use disorders on people in the U.S. and great hope for improvement in the realm of research going forward.APA strongly supports NIDA's mission. Abuse of and addiction to alcohol, nicotine, and illicit and prescription drugs cost Americans more than $700 billion a year in increased health care costs, crime, and lost productivity.1-3 Each  year, illicit and prescription drugs and alcohol contribute to the death of more than 90,000 Americans, while tobacco is linked to an estimated 480,000 deaths per year.4-5 These disorders are diagnosable and treatable, and when not treated are associated with suffering, premature death and diminished quality of life. The presence ofsubstance use disorders can also exacerbate the severity of other medical illnesses, inhibit appropriate medical management, and is associated with increased general medical costs.We particularly appreciate several aspects of NIDA’s current work and its draft strategic plan including in the basic neuroscience domain.  Efforts to gain greater knowledge about the multiplicity of factors for risk and resilience in drug use and addiction and understanding the developmental pathways of addiction and individual heterogeneity are extremely important. NIDA’s awareness of the need to focus on drug use and co- occurring conditions including HIV/AIDs is to be applauded. This priority is consonant with NIDA’s excellent work on comorbidities in relation to mental health, HIV, and the Hepatitis C virus.NIDA’s draft strategic priority centered on the development of novel, evidence-based, targeted prevention and treatment interventions in a variety of domains is essential. In particular, focused development efforts on overdose prevention and reversal hold great promise in the face of the recent epidemic levels of opiate use disorders and mortality due to overdose. The APA agrees with and praises NIDA on its attention to the public health domain and its prioritization of the identification of factors that facilitate the integration  of evidence-based research findings into healthcare policy and practice. In addition, the APA concurs with NIDA about the importance of increasing partnership with a wide variety of stakeholders to advance the dissemination of evidence-based research findings into policy and practice.APA appreciates NIDA drawing attention to the need for acceleration of development and utilization of advanced technologies. In addition, we commend NIDA’s focus on generating higher levels of transparency and reproducibility of research.We wish to acknowledge that NIDA has proposed appropriately that the domains of its draft priorities on drug use be regarded through the multiple lenses of gender, age spectrum and life course, underrepresented and underserved populations, and common comorbidities.NIDA’s draft has stimulated several additional suggestions and recommendations which we respectfully offer for NIDA’s consideration. The highlights of these suggestions span the full range of areas covered in the draft and are summarized as follows:Basic Neuroscience: Encourage research on neurobiological correlates of vulnerability to addictions and the study of treatment targets as a consideration of neurobiological correlates of recovery.Clinical and Translational Science:  Support bidirectional research involving translation  of bench findings to clinical research in humans as well as research on strengthening bedside to bench.  Ensure that functional measures are included along with biomarkers of addiction, resilience and recovery to enable personalized treatment. Support  dissemination of research so that evidence-based practices are applied in the community. Develop evidence-based approaches to substance use disorder interventions in integrated care settings. Increase efforts to develop more efficacious medications for treating addictions. Foster collaborative research involving psychiatry and general medicine given the high morbidity and mortality associated with comorbidity of substance use disorders and medical illnesses. Expand focused development efforts to study population-based strategies for treatment adherence in patients living with substance-related disorders,  HIV, and the hepatitis C virus.Public Health:  Conduct research on cost analysis and economic feasibility of treatments. Engage in greater dissemination of NIDA progress, initiatives, research and education to outlets with strong public health impact including the health media. Undertake initiatives to improve training of clinicians at the front lines of public health, equipping them with tools for clinical implementation to decrease the research-practice gap. Consider pursuing efforts to improve the understanding of how interventions should be tailored to meet the needs of diverse populations: gender, race/ethnicity, sexual orientation, gender identity and limited English proficiency. There is also a need for greater attention to the interrelationship between substance use disorders and trauma, given that sexual assault and abuse frequently trigger substantial rates of substance use disorders.Science Infrastructure: Encourage collaborative efforts with:  federal agencies including the Department of Veterans Affairs and SAMHSA; cross Institute and academic centers with brain banks and genetic material depositories; and professional organizations such as APA, American Association of Addiction Psychiatry, American Society of Addiction Medicine, and others. Develop and mentor well-trained female and underrepresented scientists in the drug abuse and addiction field at all levels. Establish a partnership between the APA and NIDA modeled after the highly successful Program for Minority Research Training in Psychiatry (PMRTP), which was funded by NIMH, to lead young researchers into the field.Unifying Themes:  Consider bringing this section to the front of the draft to assist readers in placing specific strategic priorities in context. In order to ensure that NIDA’s work addresses the full breadth of the U.S. population, include factors such as age, race, ethnicity, gender, sexual orientation, gender identity and social determinants of health.The following paragraphs delineate our detailed response to each area of NIDA’s draft strategic priorities:Basic NeuroscienceAPA proposes additions to the draft priorities in this area.Neurobiological CorrelatesWith regard to the improvement of understanding of brain circuits related to drug abuseand addiction at the cellular, circuit, and connectome levels, neurobiological correlates of vulnerability to addiction should also be included. Another area in the category of basic neuroscience that deserves attention is treatment targets, which should be a consideration of the neurobiological correlates of recovery.Comorbidity of Substance Use Disorders and Chronic DiseasesAPA requests NIDA bolsters its attention to the comorbidity of substance use disorders and medical illnesses. Thanks to previous NIDA research, it is well recognized thatsubstance use disorders are a significant contributor to the severity, morbidity, and mortality from many illnesses, including cardiovascular disease, gastrointestinaldisorders, HIV/AIDS, and pain disorders. APA recommends that NIDA expand its support for collaborative research between psychiatry and general medicine to furtheraddress these comorbidities and develop an array of effective interventions.4DiversityDrawing on one of the aforementioned unifying themes of diversity, it also is importantto consider the role of race as a determinant in the prevalence of co-occurring disorders. This issue is particularly relevant among racially diverse, vulnerable populations experiencing what has been referred to as “the triple whammy” of mental illness, addiction, and chronic disease, particularly HIV.Clinical and Translational ScienceAPA would like to suggest augmentation to NIDA’s vision in this area.Bidirectional Research, Functional Measures, Animal Models and Complex AddictionsWe recommend that NIDA consider supporting the translation of bench findings to clinical research in humans, as well as research on strengthening bedside to benchapplications (bidirectional research). With regard to clinical and translational scientific approaches, we recommend the inclusion of functional measures along with biomarkersof addiction, resilience, and recovery to enable personalized treatment. Clinical and translational research could also be used to assess the applicability of animal models or addiction mechanisms identified from animal models for human addiction vulnerability and treatment. APA encourages NIDA to support efforts on the treatment of complex addiction involving multiple substances.Age and Developmental ConsiderationsWhile addressing clinical and translational research domains, it is essential to concentrateon populations of study for focused developmental efforts including adolescents, young adults, and geriatric populations. One example of this is the need for research on addiction to prescription and pain/benzodiazepine medications and interventions for withdrawal in older adult populations.Dissemination of ResearchAPA strongly supports NIDA's dissemination of research and implementation of science so that evidence-based practices are dispersed to the community. NIDA's Clinical TrialNetwork (CTN) is an outstanding example of this important public health concept.Substance Use Disorder Treatment in Integrated SettingsChoosing where and how to invest finite resources is critically important. APA supportsNIDA's strong emphasis on the identification and evaluation of high-quality, cost- effective models for substance use disorder treatment services in integrated care settings. However, APA recommends this work build on the current excellent NIDA efforts (e.g., the development of screening tools for primary care and other healthcare professionals to assess patients or clients for tobacco, alcohol, and other drug use) to begin to focus on development of evidence-based approaches to substance use disorder interventions in these settings, such as the primary care opiate dependence intervention program.6 Theseactivities highlight the importance of integrating primary care with behavioral health components.There is a robust and growing research base documenting the ability of integrated care models to improve health outcomes. More research is needed on the dissemination and implementation of these models in a wide range of real-world practice settings, as well ason increasing our understanding of the economic impact of integrated care. APA enthusiastically supports research on the responsible integration of technology into all levels of the health care system, in the service of enhancing clinical interventions, and improving patient outcomes.Similarly, mental health services are benefiting from a growing interest in the development of collaborative care programs. Indeed, there is clear evidence of the role for integrated care in managing mental illness and reducing the disease burden of comorbid chronic conditions, such as hypertension and diabetes. Furthermore, the work of Jürgen Unützer, M.D., has identified that racial/ethnic minority women may have a more robust response to collaborative care programs than White (non-Latino) counterparts from similar socio-economic backgrounds. However, there is still a need for more research identifying effective models for the integration of substance use disorder treatment into primary care clinics. This is an additional area where NIDA can make a significant contribution.Medications for Addiction TreatmentAPA is appreciative of the development efforts on treating addictions that are currentlywithout FDA-approved medications. APA suggests these efforts include the treatment of addictions both with and without FDA-approved medications. Currently, FDA-approved medications for addictions do not lead to completely satisfactory outcomes. For example, both bupropion and varenicline (FDA-approved medications to assist with tobacco smoking) have a 1-year abstinence rate of approximately 10%, which is only double the success rate of people trying to quit without medication. Clearly, there is a great need for medications with better efficacy. A recent study showed that varenicline combined with nicotine replacement therapy was more effective than varenicline alone in achieving abstinence from tobacco but further study is needed to assess long term efficacy andsafety. 7Comorbidities of Substance Use Disorder, HIV/AIDS and Hepatitis CAPA asks that NIDA consider expanding its focused development efforts in its strategic plan to researching population-based strategies for treatment adherence in patients livingwith substance-related disorders, HIV, and the hepatitis C virus. Translational science such as this will be critical to ensuring that clinicians, substance abuse counselors, andothers have effective tools to curb the HIV epidemic. As research continues to show promising HIV-prevention interventions in drug abuse treatment settings, a cascadecontinues to exist in which the rates of treatment adherence declines for persons living with HIV and substance-related disorders who were previously linked to care.8 APA believes that continued research in treatment adherence strategies is a key to preventing the spread of HIV/AIDS and improving the vitality of patients living with HIV and asubstance-related disorder.Furthermore, the medical field has concluded that those currently most at risk for HIV are black men who have sex with men (MSM), yet there are still unmet HIV-related service delivery needs among black MSM.9 Additionally, recent evidence has shown that social determinants such as incarceration, stigma, discrimination, social isolation, mental health disparities, or social networks play a significant role in the elevated incidence rates of HIV.10 APA asks that NIDA further consider including investments in research of preventative biopsychosocial interventions that aim to meet the needs of dual-minority populations, such as the black MSM community, into their strategic plan.Public HealthEffective progress in the prevention, reduction, and recovery from substance usedisorders is a complex undertaking. Of note, prevention of substance use disorders is not thoroughly delineated in the current draft strategic priorities. In the realm of public health and the need to increase the public health impact of NIDA research and programs, APA has a number of suggestions to expand upon prevention priorities in the draft strategic plan.Cost AnalysisConducting research on costs associated with drug abuse and the economic feasibility oftreatments would be helpful to the field.Publicizing NIDA ProgressGreater dissemination of NIDA progress, initiatives, research, and education to outletswith strong public health impacts would be useful, including the health media. In particular, support for studying the efficacy of NIDA’s and other organizations’ public health messages, especially to vulnerable groups, such as adolescents, is crucial.Training of Clinicians in Public Health SettingsImplementing public health strategies for substance use disorders necessitatesimprovement in the training of clinicians at the front lines of public health, including developing and arming them with tools for clinical implementation to decrease the research-practice gap. A critical component of developing well-trained clinicians at the forefront of public health is mentorship of trainees interested in public health leadership to help address workforce shortages, an area for which NIDA is urged to consider continuing its robust support.Diverse PopulationsAPA requests that NIDA further improve the public health sector's understanding of how interventions should be tailored to meet the needs of diverse populations (e.g., gender,race/ethnicity, sexual orientation, gender identity and limited English proficiency). A specific example related to this is the recent decriminalization of non-medical cannabisuse in Washington State and Colorado. There has been an emergence of sales outlets located in communities of color. The APA suggests that NIDA consider assessingpatterns of legal sales, drug use, and disparities in impact, for example, co-location of drug oases in food deserts.Connection between Substance Use Disorders and TraumaAPA strongly encourages NIDA to focus attention on the interrelationship between substance use disorders and trauma. The field of psychosomatic medicine offers a uniquevantage point to see a powerful interplay between trauma, mental illness, stigma, addiction, and the costly medical consequences of unrecognized/untreated conditions.Data reveal that sexual assault/abuse frequently results in substantial rates of substance use disorders, and substance use disorder treatment may precipitate re-emergence ofPTSD symptoms. NIDA is uniquely positioned to advance this research through its Clinical Trial Network.Science InfrastructureEnhancing the national Science Infrastructure is required to support advancements in science. APA appreciates the suggested areas of focus in NIDA’s draft strategic plan andoffers additional input.Fostering CollaborationAPA recommends that NIDA further strengthen its collaboration with the Department ofVeterans Affairs (VA) and the Substance Abuse and Mental Health Services Administration (SAMHSA). NIDA's cooperation with the Department of Defense and the VA is critically important to advance the development of non-opioid pain management medication. Cross-institute/academic center collaborations with brain banks and other biological material depositories (such as genetics) will lead to important partnerships and advances in the field; this will require concerted efforts across the NIH Institutions. APA offers its assistance to increase collaborative efforts between NIDA and professional organizations including the APA, American Academy of Addiction Psychiatry (AAAP), American Osteopathic Academy of Addiction Medicine (AOAAM), and the American Society of Addiction Medicine (ASAM).Increase Diversity in the Scientific WorkforceWith regard to the development of human resources to augment the science infrastructure, APA requests NIDA's further efforts to cultivate well-trained female andunderrepresented scientists in the drug abuse and addiction field at all career levels. Training should include health disparities and cultural competence. Relatedly, more emphasis on the mentoring of young scientists, particularly women and under- represented minorities would be helpful to the field and would have a positive impact on patient care. APA has had great success in the past partnering with NIMH in the development of such a program, the Program for Minority Research Training in Psychiatry. This program was extremely successful, leading to the development of over 500 psychiatrist researchers from underserved and underrepresented populations whohave achieved at the highest levels of science.11 Such a program focused on women and minorities could easily be duplicated involving a partnership between the APA andNIDA.Increasing the Pipeline of Scientific ResearchersAPA recognizes the federal funding environment has impacted all of NIH. Difficultdecisions have been made at every Institute to adapt to flat research financing. Nevertheless, APA is concerned that the mechanisms to fund training and mentorship are declining and request NIDA re-examine these tools which are a critical area to develop researchers. Of particular concern to the APA is the declining number of physician- scientists and the significant delay in funding RO1 grants for young researchers. The struggle for young researchers to be funded has had an adverse effect on building the scientific workforce. Current fiscal pressures have negatively impacted research program grants (P30, P50, P60) which are utilized to develop local hubs with strategic scientific focus that can support training.  NIDA recently limited Centers to two periods of funding. APA requests NIDA revisit this funding policy to more efficiently develop sustained research programs and further develop scientific researchers on critical topics.Unifying ThemesAPA suggests that the section on unifying themes is better suited for placement at thebeginning of the plan so that each point can be considered as readers review the specific strategic priorities. Further, APA recommends this section be expanded to include a number of the following important issues.Integration of Behavioral ProcessesThe integration of behavioral processes that underlie drug abuse and addiction is a criticaland overarching issue that APA suggests NIDA give prime consideration in drug abuse research.Chronic Pain SyndromesTaking into account the treatment and prevention needs related to comorbid chronic pain syndromes and other psychiatric disorders is another example of challenges facing ournation that can guide NIDA's unifying themes going forward.DiversityIn order to ensure that NIDA’s work addresses the full breadth of the U.S. population, the impact of factors such as age, culture and ethnicity, and social determinants are areas thatAPA suggests that NIDA explore. APA applauds NIDA's dedication to studying the developing brain. The differential effects of substance use and substance use disorders onthe brains of individuals vary at different stages of development, including late childhood, early adolescence, middle and late adolescence, young adulthood, and latelife. NIDA may wish to consider expanding its research on cannabis use (medical or recreational) in the older adult population. APA supports NIDA's research on the impact of race/ethnicity, sexual phenotype, gender identity, sexual orientation, and social determinants on drug abuse. This includes research focusing on culturally- and linguistically-appropriate services among groups experiencing health disparities, such as women and underrepresented and underserved minority populations.APA appreciates the opportunity to comment on the NIDA draft strategic plan. I look forward to further discussions and continued collaborative initiatives.

Format, Basic Science, Unifying Themes

  • Suggested changes or additions to the list of strategic priorities, including emerging research needs and future opportunities that should be considered in the plan:We believe the future priorities of NIDA should take into account the increased level of legalization of cannabis, the continued abuse of prescription medications, and the potential problems associated with e-cigarettes in teenagers.An emerging research topic that is not stressed enough in the current outline is the role of the neuro immune system in the development of substance use disorders. The majority of the literature concerning neuroinflammation in drug addiction has appeared after the last strategic plan was published by NIDA. Contemplated in the past plan of strategic priorities, but we didn’t see in the present outline, is the study of specific populations, specifically, military personnel, where there is an increased abuse of prescription drugs compared to the civilian population. An example of this type of research could be the study of how post-traumatic stress disorder influence the development of drug addiction. Also, NIDA should promote research that consider the incarcerated population. In the prison system, a 65% of prisoners meet the medical criteria for substance abuse addiction, but the study of this population is not mentioned in the current outline. Lastly, behavior and environment are big components of the susceptibility and vulnerability to drug addiction. NIDA should prioritize studies that address the interaction between psychiatric diseases like major depressive disorder, anxiety disorder and the development of drug abuse.Anticipated challenges that will need to be addressed to achieve these priorities. A first step towards elucidating the pathophysiology of psychiatric disorders in addiction should include a deep knowledge of the participating neuronal circuits, the cell types, and the molecules in each neuronal population involved, and how these structures are interacting and influencing each other.

Format, Infrastructure, Basic Science

  • I am very surprised by the high number of priorities. There is ~35 strategic priorities covering pretty much every single aspect of the neuroscience of drug addiction. I don’t know a single PI whose research would not fall into one of these categories. If everything is a priority then there is no priority, and it will be a guaranteed failure. I would recommend to drastically decrease the number of priorities from 35 to ~10.To me there are 2 most critical priorities which deserve immediate actions. Successuly implementing these 2 priorities has the potential to DRAMATICALLY improve NIH-funded research, drug development and ultimately healthcare. On top of that they are most likely among the least expensive to implement.The vast majority of researchers do not need more money for their research they need better tools and better orgamizations to do their research. My car mechanic and my local grocery store has better tool than the vast majorities of labs to organize, standardize and report their business. Improve technology transfer from NIH intra-mural to extra-mural sites by fostering collaborative grants, develop short-term (3 months) intra-mural training program for extra-mural PI/postdocs/technicians and open intra-mural cores to extra-mural investigators.Improve intra-extra mural research by implementing solutions to oversee research projects, experiments and publications (development of standardized GLP-based electronic notebook, project management, and reporting, sample storage, SOPs, etc…)For the rest of the priorities below is my top 10.Basic Neuroscience: Improve our understanding of brain circuits related to drug abuse and addiction at the cellular, circuit, and connectome levels, including:Neurobiological correlates of recovery, and resistance to addiction Improve our understanding of the interaction between addiction and co-occurring conditions Clinical and Translational Science: Accelerate medications development for SUDsIdentify biomarkers of addiction, resilience, and recovery to enable personalized treatmentPublic Health: Increase the public health impact of NIDA research and programsIncrease strategic partnerships with the community (academia, pharma, biotech, healthcare organizations, policy makers, etc.) to enhance the dissemination of evidence-based research findings into policy and practice Science Infrastructure: Enhance the national research infrastructure to support advancements in scienceIncrease effective data and resource sharing (big data, biorepositories, transgenic/optogenetic tools, data standards, etc.)Enable efficiency and lower the cost of clinical trials via innovative statistical models, data standards, leveraging technology (e.g. electronic health records) and partnerships, etc.Implement GLP Experimentation of extra-mural laboratories (mandatory standardized electronic notebook, sample storage, SOPs, etc…)Improve technology transfer from NIH intra-mural to extra-mural sites

Format, Infrastructure, Unifying Themes

  • Dear Colleagues -Thank you for the opportunity to comment on the drafted Strategic Plan elements for NIDA for 2016-2022.I am writing about three items needing attention.  One item is a general language issue.  Second are two gaps I noticed in a priority. And the final one is a priority item that I think needs expansion.  I submit these considerations as an individual and not on behalf of any group or entity.  My titles and professional information are provided only to verify that these come from me in my professional capacity as an researcher, educator, licensed clinician, mentor, and advocate.FEEDBACK ON NIDA 2016-2022 STRATEGIC GOALS1. First I will address the general language issue needing attention.  The document needs to strike the word abuse from it in its entirety, excepting where there may be some historical reference to this antiquated and stigmatizing term.  Use of the word abuse is out of step with current diagnostic nosology, pejorative, and reinforces stigma.  SUGGESTED CHANGE:  I urge the removal of the term "abuse" and substitution of the word "use" and/or the phrase "use disorders" as appropriate.  RATIONALE:  This will not only remove inappropriate, outdated language, but will keep the focus across the entire range of problems we see related to substance use -- from exposure, to experimentation, to use, to problematic use, and use involving addiction.   2.  Second, I aim to address the gaps of concern to me, both of which were on science infrastructure.  On the element: Science Infrastructure: Enhance the national research infrastructure to support advancements in science, you note "improve training for the next generation of scientists."  Problem A:  What strikes me about this is that it does not explicitly address a need for work on educational technologies (we do use science in making good education, and this increasingly uses technology) and a broader focus on education of professionals.Problem B:  Additionally, it does not address the need for improving training for the next generation of clinicians, clinician-scientists, and academics - who are not necessarily scientists.  With all this talk about translation - beyond implementation in the field with those already trained - we need a focus on training that is broader and connected to basic educational matters for all professionals involved at this level of the game.So the gaps that you are talking about re: scientific infrastructure should really highlight education more generally and include educational methods and technology, not just "training."  Additionally, it needs to go beyond "scientists" to all those engaged in learning science at that level more advanced (e.g., higher level clinicians and clinician scientists and other scholars (e.g., scholars, practitioners, and scholar-practitioners).NOTE:  Conceptualization of training for these other groups really is not limited to public health matters (another element of your plan), or simply implementation science.  Instead, we are talking about, just as with researchers, part of their scientific education and training that clinicians, clinician-scientists, and scholars in this area receive, just like that received by researchers while in school, apprenticeship, fellowship, etc.  Supporting educational innovations and training of these groups is imperative as all groups receive training in science related to addictions and substance use behavior, beyond what is covered in your current expression of "improving training for the next generation of scientists." This also is not covered elsewhere adequately in your goals.   SUGGESTED CHANGE:   I suggest this noted element be amended as:  "improve education and training for the next generation of scientists, clinician-scientists, scholars, and clinicians" or "improve education and training for the next generation of professionals working in substance use and addiction science, practice, scholarship, and their interfaces." ADDITIONAL RATIONALE:  It is harder to train people after they have left their programs than while they are in them.  Let us equip the educators and trainers with the technology and funding they need do get things right while new trainees are going out the door. And let us be inclusive of the entire "symphony" of players involved - not just focusing on the scientists.  If we are truly moving into integrative, and collaborative efforts, then let us start this early, in the classrooms of all involved with the best technologies we can use.3.  Third, I aim to address the minor change and expansion of Unifying Theme priorities:  Promoting research that considers the impact of sex and gender on drug abuse and addictionAddressing health disparities among underrepresented populations PROBLEM A:  I was most pleased to see both of these items included.  However, I was somewhat taken aback to see the issue be framed with an absence of the general contribution of culture, race, and ethnicity and their contribution to use and addiction.  Our literature is deficient in these areas.  it is not just with underrepresented groups that these issues need attention.  These issues need attention on their own for their unique contributions.PROBLEM B:  These issues (sex, gender, race, ethnicity, culture) may interact with each other and/or the status of being in an underrepresented group.  Our literature remains fairly ignorant on these matters, particularly with regard to developmental issues.  Therefore age is also relevant as a universal theme, as is how these items may interact.PROBLEM C:  Socioeconomic status is a relevant demographic that needs to be teased out sensitively around all of these previously mentioned descriptors. This is because it may interact with any one or number of them to affect risk, or be its own unique risk factor.  It also may be confused with one or another of these for its impact and so should be included.SUGGESTED CHANGE:  I suggest amendment of the first bullet to fix language, address these much needed concepts (e.g., race, ethnicity, culture, age, socioeconomic status) on their own merits and not simply as a function of lumping them in to "underrepresented populations."  I also suggest amendment that accounts for how these issues may interact.  A continued focus on health disparities among underrepresented populations is not disputed, so can stand on its own.  However, the phrase "underrepresented" is inadequate to address these other very important demographic concepts and should not be used as some sort of a proxy in a strategic plan. Promoting research that considers the impact of age, sex, gender, race, ethnicity, culture, and socioeconomic status, including their interactions, on substance use and addictionAddressing health disparities among underrepresented populations RATIONALE:  Our population in the US is constantly changing.  Underrepresented status may, in and of itself, transition and be a risk factor but function in different ways for different populations.  Additionally, with our changing demographics, varied descriptors may combine to create unique risk factor patterns (for example, gendered racism) that demands study of the interaction of demographic factors such as age, race, ethnicity, and culture with sex and gender.  We also need to be careful not to confuse variables such as socioeconomic status and its impact with these other demographic issues. As such, these all need continued study for their unique and potentially interactive impact to substance use and addiction.Thank you for your consideration of these thoughts.  Again, they are submitted on my behalf as an individual, not as representing any group or entity with which I may be affiliated.

Public Health, Format

  • Thank you for asking for input for strategic planning.  I work in prevention and as a treatment engagement specialist. I would like more resources from NIDA devoted to 1)      Helping people see this as a brain disorder and a chronic health issue—such as diabetes or hypertension. 2)      Use the term “flare up” as we would with other chronic health issues, instead of relapse. 3)      Educate parents to identify mental health problems sooner.  How do they know it’s adolescent development or mental illness. I created a simple acronym:    ILL?  Each letter stands for criteria to help determine if the issue with a youth might merit professional help.     I—Intensity. How strong is it?   It’s one thing for a teen to be angry and slam the door, it’s another when a youth punches holes in the wall or you fear for your safety and have to call the police.     L—length of time.  How long as this situation gone on?  It’s one thing for her to cry after the break up with her boyfriend for a few days, it’s another when she is still crying every day 3 weeks or 3 months later.     L—limiting. Is the situation limiting your child’s normal routine?  Is the low mood so bad s/he can’t even go to school?  Has the youth dropped out of the usual interests and activities/work but not replaced them them other positive social connections? This is a simple way to help parents see they can begin to gague if it’s a mental health challenge or teen development.  Thanks