National Institute on Drug Abuse (NIDA) research priorities to support the development of incentive-based treatments for substance use disorders.

The purpose of this commentary is to highlight current research priorities of National Institute on Drug Abuse (NIDA) Division of Therapeutics and Medical Consequences (DTMC) regarding the development and testing of incentive-based interventions for the treatment of substance use disorders (SUDs). This manuscript summarizes the NIH Stage Model for behavioral intervention development, briefly reviews existing research on incentive-based treatments for SUDs that falls within the scope of DTMC at NIDA and highlights the development of digital therapeutics-based incentive interventions as an exemplar and high priority area. We briefly review how digital therapeutics approaches may address some common limitations to dissemination of incentive-based interventions and highlight opportunities for integrating incentive-based approaches into pharmacotherapy efficacy trials. Finally, we mention several related funding opportunities for researchers interested in developing incentive-based approaches for SUD treatment. The overall goal of this commentary is to inform the research community of current NIDA priority areas for intervention development and funding.

Data Collection and Harmonization in HIV Research: The Seek, Test, Treat, and Retain Initiative at the National Institute on Drug Abuse.

Large-scale, multisite data sets offer the potential for exploring the public health benefits of biomedical interventions. Data harmonization is an emerging strategy to increase the comparability of research data collected across independent studies, enabling research questions to be addressed beyond the capacity of any individual study. The National Institute on Drug Abuse recently implemented this novel strategy to prospectively collect and harmonize data across 22 independent research studies developing and empirically testing interventions to effectively deliver an HIV continuum of care to diverse drug-abusing populations. We describe this data collection and harmonization effort, collectively known as the Seek, Test, Treat, and Retain Data Collection and Harmonization Initiative, which can serve as a model applicable to other research endeavors.

Safety and feasibility clinical trial of nucleus accumbens deep brain stimulation for treatment-refractory opioid use disorder.

OBJECTIVE: There were more than 107,000 drug overdose deaths in the US in 2021, the most ever recorded. Despite advances in behavioral and pharmacological treatments, over 50% of those receiving treatment for opioid use disorder (OUD) experience drug use recurrence (relapse). Given the prevalence of OUD and other substance use disorders (SUDs), the high rate of drug use recurrence, and the number of drug overdose deaths, novel treatment strategies are desperately needed. The objective of this study was to evaluate the safety and feasibility of deep brain stimulation (DBS) targeting the nucleus accumbens (NAc)/ventral capsule (VC) and potential impact on outcomes in individuals with treatment-refractory OUD. METHODS: A prospective, open-label, single-arm study was conducted among participants with longstanding treatment-refractory OUD (along with other co-occurring SUDs) who underwent DBS in the NAc/VC. The primary study endpoint was safety; secondary/exploratory outcomes included opioid and other substance use, substance craving, and emotional symptoms throughout follow-up and 18FDG-PET neuroimaging. RESULTS: Four male participants were enrolled and all tolerated DBS surgery well with no serious adverse events (AEs) and no device- or stimulation-related AEs. Two participants sustained complete substance abstinence for > 1150 and > 520 days, respectively, with significant post-DBS reductions in substance craving, anxiety, and depression. One participant experienced post-DBS drug use recurrences with reduced frequency and severity. The DBS system was explanted in one participant due to noncompliance with treatment requirements and the study protocol. 18FDG-PET neuroimaging revealed increased glucose metabolism in the frontal regions for the participants with sustained abstinence only. CONCLUSIONS: DBS of the NAc/VC was safe, feasible, and can potentially reduce substance use, craving, and emotional symptoms in those with treatment-refractory OUD. A randomized, sham-controlled trial in a larger cohort of patients is being initiated.

Racial inequities and addiction research.

What accounts for variation across racial and ethnic groups in drug use and harms related to substance use? While explanatory mechanisms for racial and ethnic disparities include differential access to and use of health services, a myriad of other factors, including racism and historical trauma, contribute to drug-related disparities. Furthermore, the addiction scientific workforce, like the full biomedical research enterprise, lacks diversity. This deficit undercuts U.S. scientific leadership and is a major challenge for the field. To address these entrenched problems, the National Institute on Drug Abuse (NIDA) is prioritizing research on health disparities and supporting multiple efforts to enhance scientific workforce diversity. Studies on substance use trends and emerging threats must measure disparities and track progress in reducing disparities, but also acknowledge the limitations of race and ethnicity-based data. Researchers must take the bold step of proposing studies that elucidate causal mechanisms which have the potential to be ameliorated by novel policies and practices. Critically, the impact of racism on all aspects of the substance use trajectory must be assessed to better tailor prevention, harm reduction, treatment, and recovery-support interventions to the specific circumstances of those who need them. Particular attention should be given to people who are incarcerated, who are experiencing homelessness, and who have a history of adverse childhood experiences. Training the next generation of the addiction science workforce needs to address structural barriers to participation with partnerships between funders, such as NIDA, and grantee organizations.

The NIH Science of Behavior Change Program: Looking Toward the Future.

The National Institutes of Health established the Science of Behavior Change (SOBC) program to promote basic research on the initiation, personalization, and maintenance of health behavior change. The SOBC Resource and Coordinating Center now leads and supports activities to maximize the creativity, productivity, scientific rigor, and dissemination of the experimental medicine approach and experimental design resources. Here, we highlight those resources, including the Checklist for Investigating Mechanisms in Behavior-change Research (CLIMBR) guidelines introduced in this special section. We describe the ways in which SOBC can be applied across a range of domains and contexts, and end by considering ways to extend SOBC's perspective and reach, so as to best promote behavior change linked with health, quality of life, and well-being.

Advancing digital health equity: Directions for behavioral and social science research.

The field of digital health is evolving rapidly and encompasses a wide range of complex and changing technologies used to support individual and population health. The COVID-19 pandemic has augmented digital health expansion and significantly changed how digital health technologies are used. To ensure that these technologies do not create or exacerbate existing health disparities, a multi-pronged and comprehensive research approach is needed. In this commentary, we outline five recommendations for behavioral and social science researchers that are critical to promoting digital health equity. These recommendations include: (i) centering equity in research teams and theoretical approaches, (ii) focusing on issues of digital health literacy and engagement, (iii) using methods that elevate perspectives and needs of underserved populations, (iv) ensuring ethical approaches for collecting and using digital health data, and (v) developing strategies for integrating digital health tools within and across systems and settings. Taken together, these recommendations can help advance the science of digital health equity and justice.

The field of digital health is quickly growing and changing. Digital health technologies have the potential to increase access to health-related information and healthcare and improve wellbeing, but it is important that those technologies don't widen existing health disparities or create new ones. Behavioral and social science researchers have a key role to play in centering equity in their research teams and theoretical approaches, focusing on key barriers to access, uptake, and usage, studying digital health in ways that elevate the voices and needs of historically underserved groups, being thoughtful about how digital health data are collected and used, and making sure that digital health tools are designed to be used in real-world settings.

Risk and protective factors associated with patterns of antisocial behavior among nonmetropolitan adolescents.

This study used latent class analysis (LCA) to identify patterns of antisocial behavior (ASB) in a sample of 1,820 adolescents in a nonmetropolitan region of the Northeast. Self-reported ASBs including stealing, fighting, damaging property, and police contact were assessed. LCA identified four classes of ASB including a non-ASB class, a mild, a moderate, and a serious ASB class. Multinomial logistic regression indicated that parent-child relationships served as a protective factor against engaging in ASB and peer, school, and community risk and protective factors differentiated mild patterns of ASB from more intense patterns of involvment. These findings suggest utility in using the LCA to better understand predictors of adolescent ASB to inform more effective prevention and intervention efforts targeting youth who exhibit different patterns of behavior.

Deep brain stimulation of the nucleus accumbens/ventral capsule for severe and intractable opioid and benzodiazepine use disorder.

Given high relapse rates and the prevalence of overdose deaths, novel treatments for substance use disorder (SUD) are desperately needed for those who are treatment refractory. The objective of this study was to evaluate the safety of deep brain stimulation (DBS) for SUD and the effects of DBS on substance use, substance craving, emotional symptoms, and frontal/executive functions. DBS electrodes were implanted bilaterally within the Nucleus Accumbens/Ventral anterior internal capsule (NAc/VC) of a man in his early 30s with >10-year history of severe treatment refractory opioid and benzodiazepine use disorders. DBS of the NAc/VC was found to be safe with no serious adverse events noted and the participant remained abstinent and engaged in comprehensive treatment at the 12-week endpoint (and 12-month extended follow-up). Using a 0-100 visual analog scale, substance cravings decreased post-DBS implantation; most substantially in benzodiazepine craving following the final DBS titration (1.0 ± 2.2) compared to baseline (53.4 ± 29.5; p < .001). A trend toward improvement in frontal/executive function was observed on the balloon analog risk task performance following the final titration (217.7 ± 76.2) compared to baseline (131.3 ± 28.1, p = .066). FDG PET demonstrated an increase in glucose metabolism in the dorsolateral prefrontal and medial premotor cortices at the 12-week endpoint compared to post-surgery/pre-DBS titration. Heart Rate Variability (HRV) improved following the final titration (rMSSD = 56.0 ± 11.7) compared to baseline (19.2 ± 8.2; p < .001). In a participant with severe, treatment refractory opioid and benzodiazepine use disorder, DBS of the NAc/VC was safe, reduced substance use and craving, and improved frontal and executive functions. Confirmation of these findings with future studies is needed. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Social-ecological influences on patterns of substance use among non-metropolitan high school students.

Patterns of substance use are examined in a sample of over 1,200 youth in a non-metropolitan region of New England. Self-reported history and frequency of alcohol, tobacco, marijuana, inhalants, pain medications, and other hard drug use was assessed for 9th and 10th grade students. Latent class analyses identified four patterns of substance use: non-users (22%), alcohol experimenters (38%), occasional polysubstance users (29%), and frequent polysubstance users (10%). Contextual risk and protective factors in the individual, family, peer, and community domains predicted substance use patterns. Youth report of peer substance use had the largest effects on substance use class membership. Other individual characteristics (e.g., gender, antisocial behavior, academic performance, perceived harm from use), family characteristics (e.g., parental drinking, parental disapproval of youth use), and community characteristics (e.g., availability of substances) demonstrated consistent effects on substance use classes. Implications for prevention are discussed from a social-ecological perspective.

Guest editorial: Psychologists aim to HEAL the opioid and pain crises.

The opioid and pain crises affect every domain of family and community life with two million Americans living with opioid addiction, and 46,802 people dying from opioid overdoses in 2018 alone (National Center for Health Statistics, 2019). In addition, over 50 million Americans experience chronic pain, and half of those people suffer from chronic pain daily. Opioids are widely used to treat acute and chronic pain, and the lack of widespread access to nonpharmacological strategies to manage pain has contributed to the misuse of opioids. In fiscal year 2018, Congress added $500 million to the NIH's base appropriation to generate scientific solutions to the opioid and pain crises in America. The result was the Helping to End Addiction Long-Term Initiative, or NIH HEAL Initiative, a bold transagency effort. The authors of this editorial-psychologists in leadership roles in three NIH institutes- highlight several investments of the NIH HEAL Initiative, note the role of psychologists involved in HEAL, and describe the unprecedented steps the NIH is taking to harmonize data and rapidly and widely disseminate HEAL findings. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Workshop on the Development and Evaluation of Digital Therapeutics for Health Behavior Change: Science, Methods, and Projects.

The health care field has integrated advances into digital technology at an accelerating pace to improve health behavior, health care delivery, and cost-effectiveness of care. The realm of behavioral science has embraced this evolution of digital health, allowing for an exciting roadmap for advancing care by addressing the many challenges to the field via technological innovations. Digital therapeutics offer the potential to extend the reach of effective interventions at reduced cost and patient burden and to increase the potency of existing interventions. Intervention models have included the use of digital tools as supplements to standard care models, as tools that can replace a portion of treatment as usual, or as stand-alone tools accessed outside of care settings or direct to the consumer. To advance the potential public health impact of this promising line of research, multiple areas warrant further development and investigation. The Center for Technology and Behavioral Health (CTBH), a P30 Center of Excellence supported by the National Institute on Drug Abuse at the National Institutes of Health, is an interdisciplinary research center at Dartmouth College focused on the goal of harnessing existing and emerging technologies to effectively develop and deliver evidence-based interventions for substance use and co-occurring disorders. The CTBH launched a series of workshops to encourage and expand multidisciplinary collaborations among Dartmouth scientists and international CTBH affiliates engaged in research related to digital technology and behavioral health (eg, addiction science, behavioral health intervention, technology development, computer science and engineering, digital security, health economics, and implementation science). This paper summarizes a workshop conducted on the Development and Evaluation of Digital Therapeutics for Behavior Change, which addressed (1) principles of behavior change, (2) methods of identifying and testing the underlying mechanisms of behavior change, (3) conceptual frameworks for optimizing applications for mental health and addictive behavior, and (4) the diversity of experimental methods and designs that are essential to the successful development and testing of digital therapeutics. Examples were presented of ongoing CTBH projects focused on identifying and improving the measurement of health behavior change mechanisms and the development and evaluation of digital therapeutics. In summary, the workshop showcased the myriad research targets that will be instrumental in promoting and accelerating progress in the field of digital health and health behavior change and illustrated how the CTBH provides a model of multidisciplinary leadership and collaboration that can facilitate innovative, science-based efforts to address the health behavior challenges afflicting our communities.

The state of clinical outcome assessments for cannabis use disorder clinical trials: A review and research agenda.

There is considerable variability in the use of outcome measures in clinical trials for cannabis use disorder (CUD), and a lack of consensus regarding optimal outcomes may have hindered development and approval of new pharmacotherapies. The goal of this paper is to summarize an evaluation of assessment measures and clinical endpoints for CUD clinical trials, and propose a research agenda and priorities to improve CUD clinical outcome assessments. The primary recommendation is that sustained abstinence from cannabis should not be considered the primary outcome for all CUD clinical trials as it has multiple limitations. However, there are multiple challenges to the development of a reliable and valid indicator of cannabis reduction, including the lack of a standard unit of measure for the various forms of cannabis and products and the limitations of currently available biological and self-report assessments. Development of a core toolkit of assessments is needed to both allow flexibility for study design, while facilitating interpretation of outcomes across trials. Four primary agenda items for future research are identified to expedite development of improved clinical outcome assessments for this toolkit: (1) determine whether minimally invasive biologic assays could identify an acute level of cannabis use associated with psychomotor impairment or other cannabis-related harms; (2) create an indicator of quantity of cannabis use that is consistent across product types; (3) examine the presence of cannabis-specific functional outcomes; and (4) identify an optimal duration to assess changes in CUD diagnostic criteria.

Early tobacco smoking in adolescents with externalizing disorders: inferences for reward function.

INTRODUCTION: Tobacco smoking is the leading preventable cause of mortality in the United States, and 90% of regular smokers initiate smoking before age 18 years. Factors that confer risk for chronic smoking include psychiatric factors, such as externalizing disorders, and potentially related neurobiological substrates, such as reward function. The present study examined the relationship between the externalizing disorders and the temporal progression of smoking among adolescent smokers. METHODS: Data were from 64 adolescents who requested smoking cessation treatment and included information on developmental smoking trajectory, number of cigarettes per day, and Fagerström Test for Nicotine Dependence score. This sample was assessed carefully for psychiatric disorders. Analyses examined the relationships between externalizing psychiatric disorders and smoking trajectory. RESULTS: Adolescents with an externalizing disorder consumed more tobacco in the first 2 years of smoking than those without a disorder. There were no differences in speed of progression between groups, which may index a distinct functional pattern of reward systems that confers vulnerability for tobacco dependence. DISCUSSION: These data are discussed in terms of potential predictors of early smoking behavior that can inform interventions for adolescents with externalizing behaviors and tobacco dependence. They also provide some hypotheses for how the development of chronic smoking can be influenced by specific patterns of reward responses.

Risk-Taking Propensity Changes Throughout the Course of Residential Substance Abuse Treatment.

High rates of relapse following treatment have compelled researchers to elucidate the individual difference factors that change among those who receive substance abuse treatment. Previous research has suggested that trait-disinhibition variables may be of particular relevance. Given that these variables are primarily considered to be trait-level factors, the extent to which they are malleable by treatment is an important consideration. Thus, the purpose of this study was to examine the effect of a residential substance abuse treatment program on specific trait-disinhibition variables (e.g., risk-taking, impulsivity). A sample of 81 inner-city substance users were assessed on self-report and behavioral indicators of trait-disinhibition over a 30-day course of treatment. Risk-taking propensity was found to significantly decrease from pre- to post-treatment. Results are discussed with respect to implications for better understanding the factors that may operate as mechanisms of change during treatment, thereby having the potential to inform substance abuse prevention and treatment programs.

National Institutes of Health Support of Digital Health Behavior Research.

The National Institutes of Health (NIH) has increasingly supported research in digital health technologies to advance research and deliver behavior change interventions. We highlight some of the research supported by the NIH in eHealth, mHealth, and social media as well as research resources supported by the NIH to accelerate research in this area. We also describe some of the challenges and opportunities in the digital health field and the need to balance the promise of these technologies with rigorous scientific evidence.

The NIH Science of Behavior Change Program: Transforming the science through a focus on mechanisms of change.

The goal of the NIH Science of Behavior Change (SOBC) Common Fund Program is to provide the basis for an experimental medicine approach to behavior change that focuses on identifying and measuring the mechanisms that underlie behavioral patterns we are trying to change. This paper frames the development of the program within a discussion of the substantial disease burden in the U.S. attributable to behavioral factors, and details our strategies for breaking down the disease- and condition-focused silos in the behavior change field to accelerate discovery and translation. These principles serve as the foundation for our vision for a unified science of behavior change at the NIH and in the broader research community.

Toward understanding ethnic and cultural factors in the interviewing process.

The clinical interview is critical in the diagnostic assessment undertaking in clinical settings, and cultural/ethnic influences have been shown to influence the outcome of this process. Specifically, a number of studies have reported that proportionally far more ethnic minorities than Caucasians are likely to be misdiagnosed when assessed for psychiatric disorders. This particularly is the case when open clinical interviews are used. Semistructured interviews, on the other hand, result in an increase in diagnostic accuracy with ethnic minorities. Parameters associated with bias in the clinical interview of ethnic minorities and its impact on assessment, diagnosis, and treatment decisions are examined. Although the current discussion focuses primarily on African Americans, many examples are provided that pertain to other ethnic groups. Strategies for addressing these issues are explored and recommendations for increasing cultural competence are made. (PsycINFO Database Record (c) 2011 APA, all rights reserved).