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.

Randomized trial of mindfulness- and reappraisal-based regulation of craving training among daily cigarette smokers.

OBJECTIVE: Craving predicts smoking, yet existing interventions may not adequately target regulation of craving. We evaluated two versions of regulation of craving-training (ROC-T), a computerized intervention with intensive practice of strategies when exposed to smoking-related images. METHOD: Ninety-two nicotine-dependent daily smokers were randomized to mindfulness-based therapy (MBT) ROC-T focusing on mindful acceptance, and cognitive behavioral therapy (CBT) ROC-T focusing on reappraisal or no intervention control. The ROC task was administered pre- and postintervention to assess changes in cue-induced craving and mindfulness- and reappraisal-based regulation of craving. RESULTS: MBT and CBT-versus control-showed significantly greater reductions in smoking during the intervention phase (baseline to Week 4), corresponding to large (d = -1.08, 95% CI [-1.64, -0.52]) and medium-to-large effect sizes (d = -0.69, 95% CI [-1.22, -0.15]), respectively. During follow-up (Week 4-16), CBT showed significant increases in smoking, whereas MBT and control did not. For the entire study (baseline to Week 16), MBT showed significantly greater reductions in smoking compared to control (d = -1.6, 95% CI [-2.56, -0.66]) but CBT was not significantly different than control (d = -0.82, 95% CI [-1.77, 0.13]). There were no effects on smoking when directly comparing MBT and CBT. Quit rates were low across the sample, with no difference among conditions. MBT and CBT-versus control-significantly reduced cue-induced craving. CBT (but not MBT)-versus control-significantly improved reappraisal-based regulation of craving. Both MBT and CBT-versus control-significantly improved mindfulness-based regulation of craving. CONCLUSIONS: MBT- and CBT-ROC-T may reduce cue-induced craving and smoking, and MBT may be more durable than CBT. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Modafinil Does Not Reduce Cocaine Use in Methadone-Maintained Individuals.

Introduction: There are no approved medications for the treatment of cocaine use disorder (CUD). Modafinil, a cognitive-enhancer with weak stimulant-like effects, has shown promise in initial studies as a treatment for CUD. Its potential efficacy has not been examined in individuals dually dependent on cocaine and opioids. Methods: This study examined the efficacy of modafinil, in combination with contingency management (CM), for reducing cocaine and opioid use and improving cognitive function in methadone-stabilized individuals with opioid and cocaine dependence. We conducted a 17-week, double-blind, randomized controlled trial in which participants were randomized to one of four conditions: 1) modafinil + CM; 2) modafinil + yoked-control (YC); 3) placebo +CM; or 4) placebo + YC. Additionally, all subjects received platform treatments of cognitive behavioral therapy (CBT) and methadone. While the original planned sample size was N=160, a total of 91 participants were randomized. The two primary cocaine use outcomes were percentage of urine specimens positive for cocaine and percent of days of self-reported abstinence from cocaine during treatment. Cognitive function, opioid use, and secondary cocaine use outcomes were also considered. Results: Modafinil was well-tolerated with minimal reports of adverse effects. Modafinil was no more effective than placebo in reducing cocaine or opioid use or improving cognitive performance. Conclusions: In the context of a trial with robust control conditions and platform treatments, findings did not provide support for the efficacy of modafinil treatment for the treatment of CUD in methadone-stabilized individuals with dual opioid and cocaine dependence.

Racial and ethnic differences in alcohol, cannabis, and illicit substance use treatment: a systematic review and narrative synthesis of studies done in the USA.

Reports from uncontrolled trials and surveys suggest that there are disparities in substance-use outcomes for minoritised racial and ethnic populations, yet few of these disparities have emerged from randomised clinical trials (RCTs). We conducted a systematic review of RCTs published in English of Black or Latinx adults with any non-nicotine substance use disorder that reported rates of treatment initiation, engagement, or substance-use outcome by race or ethnicity. Study quality was assessed by the Joanna Briggs Institute appraisal tool and a Yale internally validated quality assessment. Of the 5204 studies, 50 RCTs met the inclusion criteria, all done in the USA, 24 compared treatment initiation, engagement, or outcome across races or ethnicities and 26 compared these same factors within a race. Few RCTs have reported outcomes specifically for Black or Latinx populations, with nine reporting significant differences by race or ethnicity. Significant differences were found in all studies that evaluated the baseline differences in social determinants. This Review explains the need for optimisation of RCTs to inform the design, delivery, and dissemination of treatment to historically excluded communities.

Computer-based training for cognitive behavioral therapy for Spanish-speaking substance users: adaptation and satisfaction.

There are few available culturally and linguistically adapted behavioral health interventions for substance use among Spanish-speaking adults. The authors describe the cultural adaptation of an innovative computer-based training for cognitive behavioral therapy program (CBT4CBT). Based in cognitive-behavioral skills training, CBT4CBT utilizes a telenovela to teach monolingual Spanish-speaking adults who have migrated to the United States to recognize triggers; avoid these situations; and cope more effectively with the consequences of substance use. Participants endorsed high levels of satisfaction with the program content and found the material to be easy to understand and relevant to their life experiences.

Religiosity and Spirituality in Latinx Individuals with Substance Use Disorders: Association with Treatment Outcomes in a Randomized Clinical Trial.

Although many studies have examined religiosity as a protective factor for substance use, few have considered its relationship to treatment outcomes among Latinx adults. Using data from 89 individuals participating in a randomized clinical trial evaluating a culturally adapted Spanish-language version of web-based cognitive behavioral therapy (CBT4CBT-Spanish) for substance use, we evaluated the relationship between religiosity, as measured by the Religious Background and Behavior questionnaire, and treatment outcomes. Overall, there were few significant correlations between religiosity scores and treatment outcomes. Past-year religiosity was positively correlated with one measure of abstinence for those randomized to CBT4CBT-Spanish, but this did not persist during a six-month follow-up period. Findings suggest that religiosity may be associated with short-term abstinence outcomes among Latinx adults receiving a culturally adapted cognitive behavioral therapy treatment. However, additional research is needed with larger and more heterogenous Latinx populations.

Identification and Validation of Distinct Latent Neurodevelopmental Profiles in the Adolescent Brain and Cognitive Development Study.

BACKGROUND: Regardless of the precise mechanism, all neurodevelopmental models of risk assume that, at the population level, there exist subgroups of individuals that share similar patterns of neural function and development-and that these subgroups somehow relate to psychiatric risk. However, the existence of multiple neurodevelopmental subgroups at the population level has not been assessed previously. METHODS: In the current study, cross-validated latent profile analysis was used to test for the presence of empirically derived, brain-based developmental subgroups using functional magnetic resonance imaging data from 6758 individuals (49.4% female; mean age = 9.94 years) in the Adolescent Brain and Cognitive Development (ABCD) study wave 1 release. Data were randomly split into training and testing samples. RESULTS: Analyses in the training sample (n = 3379) identified a seven-profile solution (entropy = 0.880) that was replicated in the held-out testing data (n = 3379, entropy = 0.890). Identified subgroups included a moderate group (66.8%), high reward (4.3%) and low reward (4.0%) groups, high inhibition (9.8%) and low inhibition (6.7%) groups, and high emotion regulation (4.0%) and low emotion regulation (4.3%) groups. Relative to the moderate group, other subgroups were characterized by more males (χ2 = 24.10, p = .0005), higher proportions of individuals from lower-income households (χ2 = 122.17, p < .0001), poorer cognitive performance (ps < .0001), more screen time (F = 6.80, p < .0001), heightened impulsivity (ps < .006), and higher rates of neurodevelopmental disorders (χ2 = 26.20, p = .0002). CONCLUSIONS: These data demonstrate the existence of multiple, distinct neurodevelopmental subgroups at the population level. They indicate that these empirically derived, brain-based developmental profiles relate to differences in clinical features, even at a young age, and prior to the peak period of risk for the development of psychopathology.

Detecting change in psychiatric functioning in clinical trials for cocaine use disorder: sensitivity of the Addiction Severity Index and Brief Symptom Inventory.

BACKGROUND: Assessment instruments commonly used in clinical trials to measure functional outcomes in substance users may lack sensitivity to detect change during treatment, potentially limiting findings regarding benefits of reduced drug use. This study evaluated the sensitivity of the Addiction Severity Index (ASI) to detect change in psychiatric functioning among cocaine users. METHODS: Data were pooled across five clinical trials for cocaine use disorder (N = 492) that included a 12-week treatment period and 6-month follow-up. Within-person cohen's d' was used to evaluate effect size of change on the Psychiatric Composite Score of the ASI (ASI-Psych) and Global Severity Index (GSI) of the Brief Symptom Inventory, as well as cocaine use. RESULTS: Effect sizes were larger for GSI than ASI-Psych from baseline to week 12 (GSI d' = 0.59; ASI-Psych d' = 0.16), and 6-month follow-up (GSI d' = 0.48; ASI-Psych d' = 0.10). For those with non-zero ASI-Psych at baseline (n = 252), medium effect sizes were found over the 12-week period (d' = 0.53) and 6-month follow-up (d' = 0.47). Effect sizes for change in days of cocaine use were most similar to GSI in either sample. CONCLUSIONS: The ASI Psychiatric Composite Score may have limited sensitivity to detect change in psychiatric functioning among clinical trial participants who reduce cocaine use. It may be useful for detecting change amongst those reporting some psychiatric problems at the start of treatment. Future research should consider an instrument's sensitivity to change when assessing the potential functional benefits of reducing cocaine use.

The profound heterogeneity of substance use disorders: Implications for treatment development.

A single treatment approach will never be sufficient to address the diversity of individuals with substance use disorders (SUDs). SUDs have historically defied definition through simple characterizations or models, and no single characterization has led to the development of broadly effective interventions. The range of dimensions of heterogeneity among individuals with SUDs, including severity, type of substance, and issues that frequently co-occur underscore that highly tailored approaches are needed. To approach personalized medicine for individuals with SUDs; two major developments are needed. First, given the diversity of individuals with SUDs, multivariate phenotyping approaches are needed to identify the particular features driving addictive processes in any individual. Second, a wider range of interventions that directly target core mechanisms of addiction and the problems that co-occur with them are needed. As clinicians cannot be expected to master the full range of interventions that may target these core processes, developing these so that they can be delivered easily, flexibly, and systematically via technology will facilitate our ability to truly tailor interventions to this highly complex and challenging population. One such technology-delivered intervention, computer-based training for cognitive behavioral therapy (CBT4CBT), is used as an example to illustrate a vision for the future of highly-tailored interventions for individuals with SUDs.

A feasibility study providing substance use treatment in the Black church.

BACKGROUND: Black adults with substance use disorders (SUDs) experience health care disparities, including access to and retention in treatment. The Black church is a trusted institution in the Black community and could be a novel setting for providing SUD treatment. METHOD: We conducted a nonrandomized feasibility study evaluating (1) whether it was possible to conduct a clinical trial of SUD treatment in this setting, (2) whether an adequate number of individuals with SUDs would participate in technology-based treatment in this setting, and (3) whether an adequate number of individuals would be retained in this setting. We evaluated computer-based training for cognitive behavioral therapy (CBT4CBT), with modifications that the church-based health advisors (CHAs), who delivered the intervention within the church, made. RESULTS: Participants were 40 Black adults, all of whom met DSM-5 criteria for a current SUD, (55% severe). The mean number of sessions completed was 6.8 and 31 completed all 7 sessions of CBT4CBT. Both self-reports and weekly urine toxicology screens indicated reduction in substance use over time. CONCLUSION: We demonstrated feasibility, as we were able to (1) collect weekly data and protect participant confidentiality, (2) recruit an adequate number of individuals with SUD, with (3) high uptake and retention of an adapted CBT4CBT in the Black church. If demonstrated to be effective in a future randomized clinical trial, delivery of technology-based treatments in the Black church may prove a promising, easily disseminable strategy to provide evidence-based interventions to an underserved and undertreated population.

Cognitive-Behavioral Interventions Targeting Alcohol or Other Drug Use and Co-Occurring Mental Health Disorders: A Meta-Analysis.

AIMS: This meta-analysis reviewed 15 clinical trials (18 study sites/arms), examining the efficacy of an integrated cognitive-behavioral intervention (CBI) delivered to individuals with an alcohol or other drug use disorder and a co-occurring mental health disorder (AOD/MHD). Outcomes were alcohol or other drug use and mental health symptoms at post-treatment through follow-up. METHODS: The inverse-variance weighted effect size was calculated for each study and pooled under random effects assumptions. RESULTS: Integrated CBI showed a small effect size for AOD (g = 0.188, P = 0.061; I2 = 86%, τ2 = 0.126, k = 18) and MHD (g = 0.169, P = 0.024; I2 = 58%, τ2 = 0.052, k = 18) outcomes, although only MHD outcomes were statistically significant. Analysis by subgroup suggested that effect magnitude varied by type of contrast condition (integrated CBI + usual care vs. usual care only; integrated CBI vs. a single-disorder intervention), follow-up time point (post-treatment vs. 3-6 months) and primary AOD/MHD diagnosis, although these sub-groups often contained significant residual heterogeneity. In a series of mixed effects, meta-regression models, demographic factors were non-significant predictors of between-study heterogeneity. For AOD outcomes, greater effects were observed in higher quality studies, but study quality was not related to effect size variability for MHD outcomes. CONCLUSIONS: The current meta-analysis shows a small and variable effect for integrated CBI with the most promising effect sizes observed for integrated CBI compared with a single disorder intervention (typically an AOD-only intervention) for follow-up outcomes, and for interventions targeting alcohol use and/or post-traumatic stress disorder. Given the clinical and methodological variability within the sample, results should be considered a preliminary, but important step forward in our understanding of treatment for co-occurring AOD/MHD.

Dissociable neural substrates of opioid and cocaine use identified via connectome-based modelling.

Opioid use disorder is a major public health crisis. While effective treatments are available, outcomes vary widely across individuals and relapse rates remain high. Understanding neural mechanisms of treatment response may facilitate the development of personalized and/or novel treatment approaches. Methadone-maintained, polysubstance-using individuals (n = 53) participated in fMRI scanning before and after substance-use treatment. Connectome-based predictive modeling (CPM)-a recently developed, whole-brain approach-was used to identify pretreatment connections associated with abstinence during the 3-month treatment. Follow-up analyses were conducted to determine the specificity of the identified opioid abstinence network across different brain states (cognitive vs. reward task vs. resting-state) and different substance use outcomes (opioid vs. cocaine abstinence). Posttreatment fMRI data were used to assess network changes over time and within-subject replication. To determine further clinical relevance, opioid abstinence network strength was compared with healthy subjects (n = 38). CPM identified an opioid abstinence network (p = 0.018), characterized by stronger within-network motor/sensory connectivity, and reduced connectivity between the motor/sensory network and medial frontal, default mode, and frontoparietal networks. This opioid abstinence network was anatomically distinct from a previously identified cocaine abstinence network. Relationships between abstinence and opioid and cocaine abstinence networks replicated across multiple brain states but did not generalize across substances. Network connectivity measured at posttreatment related to abstinence at 6-month follow-up (p < 0.009). Healthy comparison subjects displayed intermediate network strengths relative to treatment responders and nonresponders. These data indicate dissociable anatomical substrates of opioid vs. cocaine abstinence. Results may inform the development of novel opioid-specific treatment approaches to combat the opioid epidemic.

Measurement invariance of the Barratt Impulsiveness Scale across black and white adults with cocaine use disorder.

This study tests for measurement invariance of impulsivity assessed by the Barratt Impulsiveness Scale (BIS) across Black and White adults with cocaine use disorder and examines the association of BIS impulsivity with treatment retention and outcomes. Data from four clinical trials were combined providing a total sample of 302 participants with cocaine abuse/dependence (42% Black, 58% White, 44% female, agemean = 40.22, SD = 9.26). We used multi-group confirmatory factor analyses to test for measurement invariance across race and examined bivariate correlations between BIS impulsivity and treatment retention and outcomes by race. Factor analyses indicated a 22-item, two-factor (motor impulsiveness and nonplanning impulsiveness) brief BIS fit the data best (RMSEA = 0.073 [90% CI: 0.065-0.080]; CFI = 0.904; TLI = 0.893; SRMR = 0.073) and was configural, metric, and scalar invariant across race. Higher motor impulsiveness was associated with higher percentage cocaine negative urines in the overall sample (r = -0.15, p = .01), but this association only remained in the Black subsample when examined across race (r = 0.28, p < .001). Higher motor impulsiveness was also associated with increased days abstinent from cocaine in the Black subsample only (r = 0.28, p < .001). Nonplanning impulsiveness was associated with lower percentage of treatment days abstinent from cocaine in the White subsample only (r = -0.16, p = .045). These findings 1) provide evidence for a 21-item, two-factor brief BIS that is invariant across Black and White adults with cocaine use disorder, and 2) suggest that BIS impulsivity may be associated with poorer cocaine treatment outcomes among White but not Black adults.

An integrated behavioural intervention combined with varenicline for heavy-drinking smokers: a randomized pilot study.

OBJECTIVES: Combined smoking and heavy drinking is a significant health burden. Varenicline, an efficacious tobacco pharmacotherapy that also shows promise for drinking, has yielded mixed results among heavy-drinking smokers. This pilot study investigated integrated tobacco and alcohol counselling plus varenicline for this vulnerable group. DESIGN: Twelve-week parallel, randomized controlled pilot trial of two behavioural interventions in combination with open-label varenicline. Participants were randomized using computer-generated tables, stratified by sex. SETTING: Outpatient academic medical centre research clinic. PARTICIPANTS: Volunteers who reported smoking and heavy drinking and sought tobacco or alcohol treatment (N = 26). Intervention. (1) Integrated tobacco + alcohol counselling (INT; n = 13) or (2) counselling focused on their presenting concern (i.e., tobacco or alcohol) (SINGLE; n = 13), plus varenicline (2 mg) for 12 weeks. MAIN OUTCOMES: Feasibility/acceptability, smoking quit rates and heavy drinking. RESULTS: INT feasibility/acceptability was high among men but not women. More participants quit smoking in INT than SINGLE. This outcome was only in men, not significant, but had a medium effect size. Both conditions yielded significant drinking reductions. CONCLUSION: Integrated tobacco and alcohol behavioural counselling plus varenicline may be feasible and promote smoking cessation among men who smoke and drink heavily, but a larger sample is needed to replicate this finding.

Impact of 12 step mutual help groups on drug use disorder patients across six clinical trials.

BACKGROUND: 12 step mutual help groups are widely accessed by people with drug use disorder but infrequently subjected to rigorous evaluation. Pooling randomized trials containing a condition in which mutual help group attendance is actively facilitated presents an opportunity to assess the effectiveness of 12 step groups in large, diverse samples of drug use disorder patients. METHODS: Data from six federally-funded randomized trials were pooled (n = 1730) and subjected to two-stage instrumental variables modelling, and, fixed and random effects regression models. All trials included a 12 step group facilitation condition and employed the Addiction Severity Index as a core measure. RESULTS: The ability of 12 step facilitation to increase mutual help group participation among drug use disorder patients was minimal, limiting ability to employ two-stage instrumental variable models that correct for selection bias. However, traditional fixed and random effect regression models found that greater 12 step mutual help group attendance by drug use disorder patients predicted reduced use of and problems with illicit drugs and also with alcohol. CONCLUSION: Facilitating significant and lasting involvement in 12 step groups may be more challenging for drug use disorder patients than for alcohol use disorder patients, which has important implications for clinical work and for effectiveness evaluations. Though selection bias could explain part of the results of traditional regression models, the finding that participation in 12 step mutual help groups predicts lower illicit drug and alcohol use and problems in a large, diverse, sample of drug use disorder patients is encouraging.

Combined Pharmacotherapy and Cognitive Behavioral Therapy for Adults With Alcohol or Substance Use Disorders: A Systematic Review and Meta-analysis.

Importance: Substance use disorders (SUDs) represent a pressing public health concern. Combined behavioral and pharmacological interventions are considered best practices for addiction. Cognitive behavioral therapy (CBT) is a first-line intervention, yet the superiority of CBT compared with other behavioral treatments when combined with pharmacotherapy remains unclear. An understanding of the effects of combined CBT and pharmacotherapy will inform best-practice guidelines for treatment of SUD. Objective: To conduct a meta-analysis of the published literature on combined CBT and pharmacotherapy for adult alcohol use disorder (AUD) or other SUDs. Data Sources: PubMed, Cochrane Register, MEDLINE, PsychINFO, and Embase databases from January 1, 1990, through July 31, 2019, were searched. Keywords were specified in 3 categories: treatment type, outcome type, and study design. Collected data were analyzed through September 30, 2019. Study Selection: Two independent raters reviewed abstracts and full-text articles. English language articles describing randomized clinical trials examining CBT in combination with pharmacotherapy for AUD and SUD were included. Data Extraction and Synthesis: Inverse-variance weighted, random-effects estimates of effect size were pooled into 3 clinically informative subgroups: (1) CBT plus pharmacotherapy compared with usual care plus pharmacotherapy, (2) CBT plus pharmacotherapy compared with another specific therapy plus pharmacotherapy, and (3) CBT added to usual care and pharmacotherapy compared with usual care and pharmacotherapy alone. Sensitivity analyses included assessment of study quality, pooled effect size heterogeneity, publication bias, and primary substance moderator effects. Main Outcomes and Measures: Substance use frequency and quantity outcomes after treatment and during follow-up were examined. Results: The sample included 62 effect sizes from 30 unique randomized clinical trials that examined CBT in combination with some form of pharmacotherapy for AUD and SUD. The primary substances targeted in the clinical trial sample were alcohol (15 [50%]), followed by cocaine (7 [23%]) and opioids (6 [20%]). The mean (SD) age of the patient sample was 39 (6) years, with a mean (SD) of 28% (12%) female participants per study. The following pharmacotherapies were used: naltrexone hydrochloride and/or acamprosate calcium (26 of 62 effect sizes [42%]), methadone hydrochloride or combined buprenorphine hydrochloride and naltrexone (11 of 62 [18%]), disulfiram (5 of 62 [8%]), and another pharmacotherapy or mixture of pharmacotherapies (20 of 62 [32%]). Random-effects pooled estimates showed a benefit associated with combined CBT and pharmacotherapy over usual care (g range, 0.18-0.28; k = 9). However, CBT did not perform better than another specific therapy, and evidence for the addition of CBT as an add-on to combined usual care and pharmacotherapy was mixed. Moderator analysis showed variability in effect direction and magnitude by primary drug target. Conclusions and Relevance: The present study supports the efficacy of combined CBT and pharmacotherapy compared with usual care and pharmacotherapy. Cognitive behavioral therapy did not perform better than another evidence-based modality (eg, motivational enhancement therapy, contingency management) in this context or as an add-on to combined usual care and pharmacotherapy. These findings suggest that best practices in addiction treatment should include pharmacotherapy plus CBT or another evidence-based therapy, rather than usual clinical management or nonspecific counseling services.

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.

Short- and long-term changes in substance-related coping as mediators of in-person and computerized CBT for alcohol and drug use disorders.

BACKGROUND: No studies have examined long-term changes in substance-related coping skills as a statistical mediator of cognitive-behavioral therapy (CBT) for substance use disorders (SUD). METHODS: We tested both short- and long-term changes in coping as mediators of treatment effects in two trials of in-person and/or computerized CBT for SUD. The first trial included 137 individuals (75 % male; 65.7 % non-White; mean age = 35.9) with drug and/or alcohol use disorders randomized to one of the following: in-person CBT, computer-delivered CBT (CBT4CBT) plus brief monitoring, or treatment-as-usual (TAU). The second trial included 68 individuals (65 % male; 66.2 % non-white; mean age = 42.7) with an alcohol use disorder randomized to one of the following: CBT4CBT plus brief monitoring, CBT4CBT plus TAU, or TAU only. Coping was assessed with the Coping Strategies Scale. Latent growth curve mediational models were conducted, with both short-term (baseline through end-of-treatment) and long-term (baseline through 3-month post-treatment follow-up) changes in coping. RESULTS: There were no mediation effects for short-term changes in coping. However, in both trials, there were significant mediation effects for long-term changes in coping: In trial 1, the effect of CBT4CBT vs. TAU on substance use at the 6-month follow-up was mediated by long-term increases in coping. This same mediation effect was not found for in-person CBT vs. TAU. In trial 2, the effect of CBT4CBT vs. not receiving CBT4CBT on heavy drinking at the 6-month follow-up was mediated by long-term increases in coping. CONCLUSIONS: Long-term increases in coping may be a mechanism of change in computerized CBT for SUD.