Improvement in coping skills from culturally-adapted digital CBT for Spanish-speaking Hispanics with substance use disorder: Secondary analysis of a randomized clinical trial.

INTRODUCTION: Developing adaptive coping skills for avoiding substance use is a proposed treatment mechanism of cognitive behavioral therapy (CBT) for substance use disorder (SUD). However, the generalizability of research on treatment mechanisms of CBT for SUD is limited by the underrepresentation of racial/ethnic minorities in clinical trials. In a secondary analysis of clinical trial data, we tested whether a culturally-adapted digital CBT program for Hispanics ("Spanish CBT4CBT") improved the quality of coping skills for avoiding substance use. We also tested whether coping skills' quality was associated with reductions in primary substance use. METHODS: Participants were Spanish-speaking Hispanic adults seeking outpatient treatment for SUD (n = 85; 68 % male; primary substance type: 36 % cannabis, 33 % alcohol, 26 % cocaine, 5 % other). They were randomized to 8 weeks of outpatient treatment as usual (TAU) or TAU + Spanish CBT4CBT and assessed for 6 months after treatment. The study conducted separate analyses for the full sample (n = 85) and for those who engaged in at least 5 treatment sessions ("treatment exposed"; n = 64). Daily substance use and coping skills' quality were assessed repeatedly during the treatment and follow-up periods. Bayesian mixed models for repeated measures tested hypotheses. RESULTS: Among treatment-exposed participants, those receiving TAU + Spanish CBT4CBT improved the quality of coping skills more than TAU alone during the treatment period (b = 0.77; 95 % CI[0.08, 1.47]), but this difference was not detected during the follow-up period. In the full sample and treatment exposed subsample, participants with higher quality coping skills during the study reported less primary substance use (b = -0.67; 95 % CI[-1.08, -0.26]). Among treatment-exposed participants only, within-person increases in the quality of coping skills were associated with reductions in future primary substance use (b = -0.18; 95 % CI[-0.36, -0.01]). CONCLUSIONS: Spanish-speaking Hispanics with SUD may improve the quality of their coping skills more when they are sufficiently exposed to a culturally-adapted digital CBT program during outpatient treatment. Coping skills' quality may be a mechanism of CBT for SUD among Hispanic populations. Spanish-speaking Hispanics' access to treatments that target mechanisms of behavior change may be expanded by digital therapeutics.

A smartphone app-based mindfulness intervention to enhance recovery from substance use disorders: Protocol for a pilot feasibility randomized controlled trial.

Background: Poor long-term recovery outcomes after treatment (e.g., readmission to inpatient treatment) are common among individuals with substance use disorders (SUDs). In-person mindfulness-based treatments (MBTs) are efficacious for SUDs and may improve recovery outcomes. However, existing MBTs for SUD have limited public health reach, and thus scalable delivery methods are needed. A digitally-delivered MBT for SUDs may hold promise. Methods: We recently developed Mindful Journey, a smartphone app-based adjunctive MBT for improving long-term recovery outcomes. In this paper, we present details on the app and describe the protocol for a single-site pilot feasibility randomized controlled trial of Mindful Journey. In this trial, individuals (n = 34) in an early phase of outpatient treatment for SUDs will be randomized to either treatment-as-usual (TAU) plus Mindful Journey, or TAU only. The trial will focus on testing the feasibility (e.g., engagement) and acceptability of the app (e.g., perceived usability and helpfulness for recovery), as well as feasibility of study procedures (e.g., assessment completion). The trial will incorporate ecological momentary assessment before and after treatment to assess mechanisms in real-time, including mindfulness, craving, difficulties with negative emotion regulation, and savoring. To examine the sensitivity to change of outcomes (substance use, substance-related problems, and psychological distress) and mechanism variables (noted above), we will test within-treatment-condition changes over time. Discussion: The proposed pilot trial will provide important preliminary data on whether Mindful Journey is feasible and acceptable among individuals with SUDs. Trial registration: ClinicalTrials.gov NCT05109507.

A Digital Cognitive Behavioral Therapy Program for Adults With Alcohol Use Disorder: A Randomized Clinical Trial.

Importance: Cognitive behavioral therapy (CBT) is an evidence-based treatment for alcohol use, yet patient access is limited and may be enhanced through digital therapeutics. Objective: To evaluate the efficacy of a digital CBT program (Computer-Based Training for Cognitive Behavioral Therapy [CBT4CBT]) or clinician-delivered CBT compared with standard treatment for reducing alcohol use. Design, Setting, and Participants: A 3-arm randomized clinical trial was conducted at outpatient substance use treatment facilities in Connecticut between February 14, 2017, and December 31, 2021, that included an 8-week treatment period with a 6-month follow-up period. Treatment-seeking adults were included who met criteria for current alcohol use disorder and reported drinking at least 14 (men) or 7 (women) drinks per week in the past month and were sufficiently stable for outpatient treatment. Interventions: Participants were randomly assigned to 1 of the following groups: (1) treatment as usual (TAU) consisting of weekly group or individual counseling, (2) CBT delivered weekly by trained and fidelity-monitored clinicians, or (3) web-based CBT plus brief weekly clinical monitoring. Main Outcomes and Measures: Rates of alcohol use were measured weekly during the treatment period and at 1-, 3-, and 6-month follow-up using the timeline follow-back method. The primary outcome was the percentage of days abstinent (PDA) from alcohol per month. Intention-to-treat analyses were conducted. Results: Of the 99 randomized participants (mean [SD] age, 45.5 [12.7]), 66 were male (66.7%); 39 identified as Black/African American (39.8%), 19 (19.2%) as Hispanic, and 47 (48.0%) as White. Mean (SD) rates of PDA from baseline to 6-month follow-up were 49.3% (27.8%) to 69.6% (34.4%) for TAU; 53.7% (29.8%) to 70.2% (35.1%) for CBT; and 47.6% (31.8%) to 82.6% (25.3%) for digital CBT. Results of random-effects regression showed a significant increase in PDA during the study period, with those assigned to digital CBT increasing PDA at a faster rate than TAU (t733 = 2.55; P = .01) and CBT (t733 = 3.36; P < .001). However, there was no statistically significant difference between treatment groups during the 8-week treatment period. Conclusions and Relevance: In this randomized clinical trial, while there was no significant difference between treatment groups during the 8-week treatment period, there was differential change between treatments during the 8-month study period that provides support for the efficacy of this digital CBT program. Trial Registration: ClinicalTrials.gov Identifier: NCT02742246.

Measurement invariance of the Perceived Stress Scale across race, sex, and time, and differential impacts on cocaine use treatment outcomes.

INTRODUCTION: To understand the influence of phenotypic characteristics, such as stress, on substance use treatment outcomes, measures must function equivalently across groups to allow for interpretable comparisons of effects. The present study evaluated measurement invariance of the Perceived Stress Scale (PSS) across race, sex, and time, examined its association with cocaine use disorder (CUD) treatment outcomes, and tested whether associations were moderated by race and/or sex. METHODS: Data from four clinical trials evaluating behavioral and/or pharmacological treatments for cocaine use were combined providing a total sample of 302 participants with DSM-IV cocaine abuse/dependence (57.6 % Black, 42.4 % White, 43.7 % females, Mage = 40.22 years, SD = 9.26). RESULTS: Factor analyses support a two-factor model (i.e., general stress, self-efficacy to cope with stressors) that demonstrated configural, metric, and scalar invariance across race and sex and configural and metric invariance across time. End-of-treatment stress and coping were both related to treatment outcomes, but not treatment retention. Interactions between baseline and end-of-treatment stress and coping self-efficacy with race and sex predicting treatment retention and outcomes were not significant. CONCLUSIONS: Results support the utility of the PSS to examine between-group differences among individuals with CUD and suggest that sociodemographic groups differ in the extent to which stress and self-efficacy to cope influence treatment outcomes.

From alcohol and other drug treatment mediator to mechanism to implementation: A systematic review and the cases of self-efficacy, social support, and craving.

Research designed to establish alcohol and other drug (AOD) mechanisms of behavioral change (MOBC) has centered on what variables mediate the relation between AOD treatment and outcomes. The purpose of this paper was to review this research evidence to identify empirically supported mediators of alcohol and other drug use and related outcomes and then to evaluate their potential as being AOD treatment MOBC. The first phase was a systematic review of reviews (2008-2023) to identify the variables with the strongest empirical support as mediators of AOD treatment effects. Eligible reviews focused on AOD treatment modalities, included empirically tested mediators, and targeted adult samples. The second phase was a systematic review of empirical studies (1990-2023) testing the hypothesis that variables identified in phase one were AOD treatment mediators/mechanisms and then evaluating each eligible stage two study according to the Kazdin and Nock (Journal of Child Psychology and Psychiatry, 44, 1116) criteria. Eligible articles included empirical studies with adult samples attending AOD treatment and empirically tested one of the three treatment mechanisms as a mediator of an AOD-related outcome. Databases were searched in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. This systematic review was not preregistered. The first review of 11 eligible review articles identified self-efficacy, social support, and craving as having the strongest empirical support. The second review captured 48 individual studies. An evaluation of each of these studies by the Kazdin and Nock criteria suggested that they likely are MOBC and therefore are ready for implementation. The implementation of self-efficacy, social support, and craving into clinical practice and training is warranted. Six directions for future research to solidify and generalize empirical support for the case that self-efficacy, social support, and craving are MOBC are presented, as are five implications for clinical practice and training.

A Descriptive Review and Meta-Regression Study of Demographic and Study Context Factors in US Clinical Trials of Cognitive Behavioral Interventions for Alcohol or Other Drug Use.

Objectives. Cognitive-Behaviorally Based Interventions (CBIs) are evidence-based treatments for alcohol and other drug (AOD) use with potential variable effectiveness by population sub-groups. This study used evidence synthesis to examine treatment effect by demographic and study context factors in clinical trials of CBI for AOD. Methods. Studies were systematically identified, and their characteristics and outcome data were extracted and summarized. Standardized mean differences were calculated for within- and between-condition effects on substance use outcomes. Demographic and study context moderators were identified during data acquisition and several sensitivity analyses were conducted. Results. The sample included K = 29 trials and a total of 15 study-level moderators were examined. Information on participants' age, biological sex, and race were reported in at least 26 trials, but information on gender identity, sexual orientation, and ethnicity were reported infrequently or in non-inclusive ways. The mean between-condition effect size was small and moderately heterogenous (d = 0.158, 95% CI = 0.079, 0.238, I2 = 46%) and the mean within-condition effect size was large and showed high heterogeneity (dz = 1.147, 95% CI = 0.811, 1.482, - I2 = 96%). The specific drug targeted in the study and whether biological assay-based outcomes were used moderated between-condition CBI efficacy and the inclusion of co-occurring mental health conditions and study publication date moderated within-condition CBI effects. Conclusions. Results provide preliminary data on study context factors associated with effect estimates in United States based clinical trials of CBI for AOD.

Structural brain changes associated with cocaine use and digital cognitive behavioral therapy in cocaine use disorder treatment.

Background: Few studies have investigated changes in brain structure and function associated with recovery from cocaine use disorder (CUD), and fewer still have identified brain changes associated with specific CUD treatments, which could inform treatment development and optimization. Methods: In this longitudinal study, T1-weighted magnetic resonance imaging scans were acquired from 41 methadone-maintained individuals with CUD (15 women) at the beginning of and after 12 weeks of outpatient treatment. As part of a larger randomized controlled trial, these participants were randomly assigned to receive (or not) computer-based training for cognitive behavioral therapy (CBT4CBT), and galantamine (or placebo). Results: Irrespective of treatment condition, whole-brain voxel-based morphometry analyses revealed a significant decrease in right caudate body, bilateral cerebellum, and right middle temporal gyrus gray matter volume (GMV) at post-treatment relative to the start of treatment. Subsequent region of interest analyses found that greater reductions in right caudate and bilateral cerebellar GMV were associated with higher relative and absolute levels of cocaine use during treatment, respectively. Participants who completed more CBT4CBT modules had a greater reduction in right middle temporal gyrus GMV. Conclusions: These results extend previous findings regarding changes in caudate and cerebellar GMV as a function of cocaine use and provide the first evidence of a change in brain structure as a function of engagement in digital CBT for addiction. These data suggest a novel potential mechanism underlying how CBT4CBT and CBT more broadly may exert therapeutic effects on substance-use-related behaviors through brain regions implicated in semantic knowledge.

Examining cocaine use reductions and long-term outcomes in two clinical trials of continuing care for cocaine dependence.

BACKGROUND: There is a need to identify clinically meaningful non-abstinent endpoints for cocaine use disorder (CUD) clinical trials. In this study, we sought to replicate and extend prior work validating reductions in cocaine use frequency levels as an endpoint by examining associations between reductions in cocaine use frequency and long-term functioning outcomes. METHODS: We conducted a secondary analysis of two randomized clinical trials (N = 445; 77.5 % male; mean age = 42.18 years; 86.5 % Black, 10.8 % non-Hispanic white) that evaluated telephone-based continuing care for a 12- and 24-month period. Cocaine use frequency levels, measured with the Timeline Followback, were (1) abstinence (no past-month cocaine use), (2) low-frequency use (1-4 days of use/month), and (3) high-frequency use (5+ days of use/month). RESULTS: Among those who completed the 12-month follow-up (n = 392), most reduced from high-frequency use at baseline to abstinence at the 12-month follow-up (n = 243; 62.0 %). An additional 21.2 % (n = 83) reported either high-to-low-frequency use (n = 35; 8.9 %) or low use-to-abstinence (n = 48; 12.2 %); 16.8 % of participants (n = 66) did not change or increased their cocaine frequency level. Compared to those who had no change/increases in frequency levels, at least a one-level reduction from baseline to 12-month follow-up (i.e., high-to-low-frequency use, high-to-abstinence, low-to-abstinence) was concurrently associated with lower levels of negative consequences at the 12-month follow-up and prospectively with lower levels of cocaine use and consequences at 24-month follow-up, with effect sizes in the medium-to-large range. Those who reduced to abstinence generally had fewer drug use consequences at the 12-month follow-up than those who reduced to a low-frequency level; however, these groups did not significantly differ on any outcomes at the 24-month follow-up. CONCLUSIONS: Categorical reductions in cocaine use frequency levels, including those short of abstinence, are associated with less cocaine use and lower problem severity up to two years following treatment entry. Low-frequency cocaine use following the initial treatment phase does not appear to forebode worsening functioning, such as escalations in cocaine use.

Understanding the patient and supporter journey in cocaine use disorder.

Background: There is a paucity of literature describing experiences and journey of individuals with cocaine use disorder (CUD) and supporters who care for them. The aim of this study was to understand and document the journey of individuals with current CUD, those in CUD remission, and supporters. Methods: The online bulletin board (OBB) is a qualitative tool where participants engage in an interactive discussion on a virtual forum. After completing a 15-minute screening questionnaire determining eligibility, individuals in CUD remission and supporters participated in an OBB for 60 minutes, split across 8 days over 2 weeks. Individuals with current CUD participated in a one-time virtual focus group discussion for 90 minutes. Results: Individuals in CUD remission (n=35) were from Brazil, France, Spain, the UK, and the US; those with current CUD (n=5) and supporters (n=6) were from the US. Key insights were that individuals with current CUD were seeking a 'euphoric high' that cocaine provides. Those in CUD remission described a 'euphoric high' when they first tried cocaine, but over time it became harder to re-create this feeling. Individuals in CUD remission expressed a 'rollercoaster' of emotions from when they first started using cocaine to when they stopped. Supporters were sad, isolated, and worried about a potential cocaine overdose for their loved ones with CUD. Conclusion: The study provides valuable insights into the experiences and journey of individuals with CUD and their supporters. Data generated from this study gives insights into this under-served and growing population.

Patient perspectives on current and potential therapies and clinical trial approaches for cocaine use disorder.

Background: Cocaine use disorder (CUD) is characterized by the continued use of cocaine despite serious impacts on life. This study focused on understanding the perspective of individuals with current CUD, individuals in CUD remission, and their supporters regarding current therapies, future therapies, and views on clinical trials for CUD. Methods: The online bulletin board (OBB) is a qualitative tool where participants engage in an interactive discussion on a virtual forum. Following completion of a screening questionnaire to determine eligibility, individuals in CUD remission and their supporters logged in to the OBB and responded to questions posed by the moderator. Individuals with current CUD participated in a one-time virtual focus group. Results: All individuals with current CUD and 94% of those in CUD remission reported a diagnosis consistent with CUD or substance use disorder during screening. Individuals with current CUD and their supporters were recruited from the United States (US). Individuals in CUD remission were recruited from five countries, including the US. Individuals with current CUD reported hesitation about seeking treatment due to stigma, a lack of privacy, and being labeled as a drug seeker; barriers to therapy included time, cost, and a lack of privacy. Participants wanted a safe therapy to stop cravings and withdrawal symptoms. Seven clinical trial outcomes, including long-term abstinence and craving control, were suggested based on collected insights. Conclusion: This study can help inform the design of clinical trials and emphasize the need for effective, safe, and accessible therapies. Recruiting participants will require significant trust building.

Development and initial testing of mindful journey: a digital mindfulness-based intervention for promoting recovery from Substance use disorder.

BACKGROUND/OBJECTIVES: There is a great unmet need for accessible adjunctive interventions to promote long-term recovery from substance use disorder (SUD). This study aimed to iteratively develop and test the initial feasibility and acceptability of Mindful Journey, a novel digital mindfulness-based intervention for promoting recovery among individuals with SUD. PATIENTS/MATERIALS: Ten adults receiving outpatient treatment for SUD. METHODS: Phase 1 (n = 5) involved developing and testing a single introductory digital lesson. Phase 2 included a separate sample (n = 5) and involved testing all 15 digital lessons (each 30- to 45-minutes) over a 6-week period, while also receiving weekly brief phone coaching for motivational/technical support. RESULTS: Across both phases, quantitative ratings (rated on a 5-point scale) were all at or above a 4 (corresponding with 'agree') for key acceptability dimensions, such as usability, understandability, appeal of visual content, how engaging the content was, and helpfulness for recovery. Additionally, in both phases, qualitative feedback indicated that participants particularly appreciated the BOAT (Breath, Observe, Accept, Take a Moment) tool for breaking down mindfulness into steps. Qualitative feedback was used to iteratively refine the intervention. For example, based on feedback, we added a second core mindfulness tool, the SOAK (Stop, Observe, Appreciate, Keep Curious), and we added more example clients and group therapy videos. In Phase 2, 4 out of 5 participants completed all 15 lessons, providing initial evidence of feasibility. Participants reported that the phone coaching motivated them to use the app. The final version of Mindful Journey was a smartphone app with additional features, including brief on-the-go audio exercises and a library of mindfulness practices. Although, participants used these additional features infrequently. CONCLUSIONS: Based on promising initial findings, future acceptability and feasibility testing in a larger sample is warranted. Future versions might include push notifications to facilitate engagement in the additional app features.

A non-randomized pilot study protocol of a novel social support intervention for individuals in early recovery from hazardous alcohol use.

INTRODUCTION: Connecting individuals to recovery support services such as recovery community centers and mutual help organizations can be crucial for sustaining recovery from addiction. However, there may be barriers to engagement with recovery support services on individual (e.g., limited motivation) and structural (e.g., limited information on recovery resources) levels. This pilot study will determine the feasibility and acceptability of a novel online social support intervention (Let's Do Addiction Recovery Together!, abbreviated as LDART) that uses pre-recorded videos created by members from several recovery support services to help individuals in early recovery from hazardous alcohol use sustain motivation during recovery and introduce them to freely available recovery support services in the community. METHODS AND ANALYSIS: This will be a non-randomized mixed-method pilot study. We will recruit 30 adults who engaged in past-year hazardous alcohol use and have some desire to cut down or quit to use LDART every night for a month. A subset of these participants will be invited to participate in a semi-structured qualitative interview after completing the study. Primary outcomes will be feasibility parameters such as recruitment and retention rates, and acceptability measures such as frequency of intervention use. Secondary outcomes will include self-reported changes in alcohol use, engagement in recovery support services, and quality of life at one-month post-intervention relative to baseline. DISCUSSION: Results of this pilot study will inform a randomized controlled trial to examine efficacy of this intervention, with the goal of creating an accessible and scalable intervention that has direct benefits on individuals who want to cut down or quit problematic alcohol use. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT06022107.

Promoting alcohol treatment engagement post-hospitalization with brief intervention, medications and CBT4CBT: protocol for a randomized clinical trial in a diverse patient population.

BACKGROUND: Alcohol use disorder (AUD) commonly causes hospitalization, particularly for individuals disproportionately impacted by structural racism and other forms of marginalization. The optimal approach for engaging hospitalized patients with AUD in treatment post-hospital discharge is unknown. We describe the rationale, aims, and protocol for Project ENHANCE (ENhancing Hospital-initiated Alcohol TreatmeNt to InCrease Engagement), a clinical trial testing increasingly intensive approaches using a hybrid type 1 effectiveness-implementation approach. METHODS: We are randomizing English and/or Spanish-speaking individuals with untreated AUD (n = 450) from a large, urban, academic hospital in New Haven, CT to: (1) Brief Negotiation Interview (with referral and telephone booster) alone (BNI), (2) BNI plus facilitated initiation of medications for alcohol use disorder (BNI + MAUD), or (3) BNI + MAUD + initiation of computer-based training for cognitive behavioral therapy (CBT4CBT, BNI + MAUD + CBT4CBT). Interventions are delivered by Health Promotion Advocates. The primary outcome is AUD treatment engagement 34 days post-hospital discharge. Secondary outcomes include AUD treatment engagement 90 days post-discharge and changes in self-reported alcohol use and phosphatidylethanol. Exploratory outcomes include health care utilization. We will explore whether the effectiveness of the interventions on AUD treatment engagement and alcohol use outcomes differ across and within racialized and ethnic groups, consistent with disproportionate impacts of AUD. Lastly, we will conduct an implementation-focused process evaluation, including individual-level collection and statistical comparisons between the three conditions of costs to providers and to patients, cost-effectiveness indices (effectiveness/cost ratios), and cost-benefit indices (benefit/cost ratios, net benefit [benefits minus costs). Graphs of individual- and group-level effectiveness x cost, and benefits x costs, will portray relationships between costs and effectiveness and between costs and benefits for the three conditions, in a manner that community representatives also should be able to understand and use. CONCLUSIONS: Project ENHANCE is expected to generate novel findings to inform future hospital-based efforts to promote AUD treatment engagement among diverse patient populations, including those most impacted by AUD. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT05338151.

Percentage of negative urine drug screens as a clinically meaningful endpoint for RCTs evaluating treatment for cocaine use.

BACKGROUND: This study examined a threshold based on the percentage of cocaine-negative (CN) urine drug screens (UDS) collected during treatment as a potential meaningful endpoint for clinical trials. We hypothesized that individuals providing at least 75% CN UDS would have better long-term outcomes than those providing less than 75% CN UDS. METHODS: Two separate pooled datasets of randomized clinical trials conducted at different institutions were used for analyses: one composed of eight trials (N = 760) and the other composed of three trials (N = 416), all evaluating behavioral and/or pharmacological treatments for cocaine use. UDS were collected at least once per week (up to three times per week) during the 8- or 12-week treatment period across all trials, with substance use and psychosocial functioning measured up to 12 months following treatment. Chi-squares and ANOVAs compared within-treatment and follow-up outcomes between the groups. RESULTS: Compared to those who did not achieve the threshold, participants who achieved the 75%-CN threshold were retained in treatment longer and had a longer period of continuous abstinence, and were more likely to report problem-free functioning. Additionally, participants who achieved the 75%-CN threshold were more likely to report sustained abstinence and better psychosocial functioning throughout a follow-up period up to 12 months than those who did not achieve the threshold. CONCLUSIONS: A threshold of 75%-CN UDS is associated with short- and long-term clinical benefits. Future clinical trials may consider this a meaningful threshold for defining treatment responders.

Distinct neural networks predict cocaine versus cannabis treatment outcomes.

Treatment outcomes for individuals with substance use disorders (SUDs) are variable and more individualized approaches may be needed. Cross-validated, machine-learning methods are well-suited for probing neural mechanisms of treatment outcomes. Our prior work applied one such approach, connectome-based predictive modeling (CPM), to identify dissociable and substance-specific neural networks of cocaine and opioid abstinence. In Study 1, we aimed to replicate and extend prior work by testing the predictive ability of the cocaine network in an independent sample of 43 participants from a trial of cognitive-behavioral therapy for SUD, and evaluating its ability to predict cannabis abstinence. In Study 2, CPM was applied to identify an independent cannabis abstinence network. Additional participants were identified for a combined sample of 33 with cannabis-use disorder. Participants underwent fMRI scanning before and after treatment. Additional samples of 53 individuals with co-occurring cocaine and opioid-use disorders and 38 comparison subjects were used to assess substance specificity and network strength relative to participants without SUDs. Results demonstrated a second external replication of the cocaine network predicting future cocaine abstinence, however it did not generalize to cannabis abstinence. An independent CPM identified a novel cannabis abstinence network, which was (i) anatomically distinct from the cocaine network, (ii) specific for predicting cannabis abstinence, and for which (iii) network strength was significantly stronger in treatment responders relative to control particpants. Results provide further evidence for substance specificity of neural predictors of abstinence and provide insight into neural mechanisms of successful cannabis treatment, thereby identifying novel treatment targets. Clinical trials registation: "Computer-based training in cognitive-behavioral therapy web-based (Man VS Machine)", registration number: NCT01442597 . "Maximizing the Efficacy of Cognitive Behavior Therapy and Contingency Management", registration number: NCT00350649 . "Computer-Based Training in Cognitive Behavior Therapy (CBT4CBT)", registration number: NCT01406899 .

Addictions treatment mechanisms of change science and implementation science: A critical review.

This manuscript aims to contribute to the next phase of mechanisms of behavior change (MOBC) science on alcohol or other drug use. Specifically, we encourage the transition from a basic science orientation (i.e., knowledge generation) to a translational science orientation (i.e., knowledge application or Translational MOBC Science). To inform that transition, we examine MOBC science and implementation science and consider how these two research areas can intersect to capitalize on the goals, strengths, and key methodologies of each. First, we define MOBC science and implementation science and offer a brief historical rationale for these two areas of clinical research. Second, we summarize similarities in rationale and discuss two scenarios where one draws from the other-MOBC science on implementation strategy outcomes and implementation science on MOBC. We then focus on the latter scenario, and briefly review the MOBC knowledge base to consider its readiness for knowledge translation. Finally, we provide a series of research recommendations to facilitate the translation of MOBC science. These recommendations include: (1) identifying and targeting MOBC that are well suited for implementation, (2) use of MOBC research results to inform broader health behavior change theory, and (3) triangulation of a more diverse set of research methodologies to build a translational MOBC knowledge base. Ultimately, it is important for gains borne from MOBC science to affect direct patient care, while basic MOBC research continues to be developed and refined over time. Potential implications of these developments include greater clinical significance for MOBC science, an efficient feedback loop between clinical research methodologies, a multi-level approach to understanding behavioral change, and reduced or eliminated siloes between MOBC science and implementation science.

Efficacy of Cognitive Behavioral Therapy for Alcohol and Other Drug Use Disorders: Is a One-Size-Fits-All Approach Appropriate?

Purpose: We provide an overview of Cognitive Behavioral Therapy (CBT) efficacy for adult alcohol or other drug use disorders (AOD) and consider some key variations in application as well as contextual (ie, moderators) or mechanistic (ie, mediators) factors related to intervention outcomes. Methods: This work is a narrative overview of the review literature on CBT for AOD. Results: Robust evidence suggests the efficacy of classical/traditional CBT compared to minimal and usual care control conditions. CBT combined with another evidence-based treatment such as Motivational Interviewing, Contingency Management, or pharmacotherapy is also efficacious compared to minimal and usual care control conditions, but no form of CBT consistently demonstrates efficacy compared to other empirically-supported modalities. CBT and integrative forms of CBT have potential for flexible application such as use in a digital format. Data on mechanisms of action, however, are quite limited and this is despite preliminary evidence that shows that CBT effect sizes on mechanistic outcomes (ie, secondary measures of psychosocial adjustment) are moderate and typically larger than those for AOD use. Conclusion: CBT for AOD is a well-established intervention with demonstrated efficacy, effect sizes are in the small-to-moderate range, and there is potential for tailoring given the modular format of the intervention. Future work should consider mechanisms of CBT efficacy and key conditions for dissemination and implementation with fidelity.

Clinical Trial Design Challenges and Opportunities for Emerging Treatments for Opioid Use Disorder: A Review.

Importance: Novel treatments for opioid use disorder (OUD) are needed to address both the ongoing opioid epidemic and long-standing barriers to existing OUD treatments that target the endogenous µ-opioid receptor (MOR) system. The goal of this review is to highlight unique clinical trial design considerations for the study of emerging treatments for OUD that address targets beyond the MOR system. In November 2019, the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US Food and Drug Administration sponsored a meeting to discuss the current evidence regarding potential treatments for OUD, including cannabinoids, psychedelics, sedative-hypnotics, and immunotherapeutics, such as vaccines. Observations: Consensus recommendations are presented regarding the most critical elements of trial design for the evaluation of novel OUD treatments, such as: (1) stage of treatment that will be targeted (eg, seeking treatment, early abstinence/detoxification, long-term recovery); (2) role of treatment (adjunctive with or independent of existing OUD treatments); (3) primary outcomes informed by patient preferences that assess opioid use (including changes in patterns of use), treatment retention, and/or global functioning and quality of life; and (4) adverse events, including the potential for opioid-related relapse or overdose, especially if the patient is not simultaneously taking maintenance MOR agonist or antagonist medications. Conclusions and Relevance: Applying the recommendations provided here as well as considering input from people with lived experience in the design phase will accelerate the development, translation, and uptake of effective and safe therapeutics for individuals struggling with OUD.

The rise and fall of substance use during treatment: Applying recency and expectancy principles to daily substance use patterns.

OBJECTIVE: Clinical trials for substance use disorder (SUD) often assess outcomes by aggregating substance use data into weekly proportions. However, daily substance use patterns may reveal how motivation changes during treatment. Neurocognitive principles of recency and expectancy indicate the salience of treatment mechanisms would increase on days proximal to therapy sessions. This study tested whether substance use decreased on days near treatment sessions. METHOD: Bayesian multilevel models were used in a secondary analysis of randomized clinical trial data comparing cognitive behavioral therapy (CBT), computerized CBT, and treatment as usual during outpatient SUD treatment (n = 94; 76% males; Mage = 38; 46% African American, 38% White, 6% multiracial, 10% other; 17% Hispanic). The number of days before/after a therapy session was used to predict daily substance use assessed by weekly self-reports. RESULTS: The models suggested that substance use increased as more days passed after a therapy session (b = 5.23) and then decelerated before the next therapy session (b² = -8.20). The evidence indicated that substance use was less likely on therapy days and the days after therapy. Primary drug type, SUD severity, and treatment condition moderated these findings. CONCLUSIONS: Substance use patterns during treatment were consistent with recency and expectancy neurocognitive principles. Substance use decreased on days closer to a therapy session, suggesting that treatment mechanisms were more salient on those days. More frequent therapeutic contact and targeted timing of treatment delivery may enhance treatment efficacy. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

The Effect of Cognitive Behavioral Therapy on Impulsivity in Addictive Disorders: a Narrative Review.

Purpose of Review: Impulsivity is considered an important construct in the cycle of addiction, yet the effect of evidence-based treatments on impulsivity is unclear. The goal of this paper was to review the evidence regarding the effect of cognitive behavioral therapy (CBT), one of the most studied psychotherapies for addiction, on measures of impulsivity in addictive disorders. Recent Findings: There is a robust literature implicating impulsivity as risk factor for development of a range of addictions and poorer treatment outcomes. However, this review identified only four randomized controlled trials evaluating CBT for an addictive behavior that included repeated assessment of impulsivity. All four were studies targeting substance use. Summary: There is limited evidence that CBT has a direct effect on change in measures of impulsivity among individuals being treated for substance use. Future clinical trials should include repeated measurement of impulsivity to examine CBT's effect on the underlying characteristics of addiction.