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.

Mechanisms of Behavior Change in Adolescent Substance Use Treatment: A Systematic Review of Treatment Mediators and Recommendations for Advancing Future Research.

Substance use disorders commonly onset during adolescence, yet the best available treatments yield only modest and transient effects. Elucidating treatment mediators is essential for improving treatment options. This review summarizes over 20 years of research on mediators of adolescent substance use treatment; k = 17 studies assessing both treatment or treatment ingredient to mediator (a path) and mediator to treatment outcome (b path) paths were included. Mediators were categorized using the Science of Behavior Change target class framework. Overall, mediation tests supported four of eight self-regulation, two of 10 stress resilience and reactivity, six of 19 interpersonal and social process, and two of four treatment engagement and adherence mediators. To enhance the capacity of this work to inform clinical practice, we recommend future research examine theoretically informed mechanisms using temporally sequenced data among other methodological guidelines.

Defining the therapeutic relationship in the context of alcohol use, other drug use, and behavior change: Principles and practices.

OVERVIEW: This article contributes to knowledge and practice of core processes that are shared by evidence-based alcohol or other drug (AOD) therapies. It is the fourth in a series with this aim, and here we discuss perhaps the most universally acknowledged ingredient of effective therapy - the therapeutic relationship. We consider various related terms and definitions in the literature, but in the present review, we offer a definition that underscores the context of behavior change. METHOD: This study conducted a literature review and qualitative content analysis to derive a set of principles and practices for facilitating and maintaining the therapeutic relationship. The sources for this review included government-issued practice guidelines, therapy manuals or books, demonstration videos, and peer-reviewed articles (61 sources). The content analysis was performed in NVIVO, and reliability analysis showed moderate agreement between raters (kappa = 0.60). RESULTS: Six principles and 16 practices were identified. The distribution of principles and practices could be broken into three categories: 1) the facilitation of client behavior change mechanisms (i.e., self-determination, motivation, self-efficacy), 2) partnership considerations (e.g., goal and task alignment), and 3) therapist interpersonal skills (e.g., empathy). CONCLUSIONS: The therapeutic relationship is foundational to the behavior change process. We frame it as a combination of broader interpersonal considerations and attention to key mechanisms of client behavior change. The present work provides a novel resource for trainees, clinicians, and clinical supervisors interested in fostering therapy relationships with clients in AOD or other behavior change settings.

Leveraging meta-regression to test if medication effects on cue-induced craving are associated with clinical efficacy.

RATIONALE: The alcohol cue exposure paradigm is a common method for evaluating new treatments for alcohol use disorder (AUD); however, it is unclear if medication-related reductions in cue-induced craving in the human laboratory can predict the clinical success of those medications in reducing alcohol consumption during clinical trials. OBJECTIVES: To use a novel meta-analytic approach to test whether medication effect sizes on cue-induced alcohol craving are associated with clinical efficacy in clinical trials. METHOD: We searched the literature for medications tested for AUD treatment using both the alcohol cue-reactivity paradigm and randomized clinical trials (RCTs). For alcohol cue-reactivity studies, we computed medication effect sizes for cue-induced alcohol craving (k = 36 studies, 15 medications). For RCTs, we calculated medication effect sizes for heavy drinking and abstinence (k = 139 studies, 19 medications). Using medication as the unit of analysis, we applied the Williamson-York bivariate weighted least squares estimation to account for errors in both independent and dependent variables. We also conducted leave-one-out cross validation simulations to examine the predictive utility of cue-craving medication effect sizes on RCT heavy drinking and abstinence endpoints. RESULTS: There was no significant relationship between medication effects on cue-induced alcohol craving in the human laboratory and medication effects on heavy drinking ( ß ^ = 0.253, SE = 0.189, p = 0.090) and abstinence ( ß ^ = 0.829, SE = 0.747, p = 0.133) in RCTs. CONCLUSIONS: The preliminary results of the current study challenge the assumption that alcohol cue-reactivity alone can be used as an early efficacy indicator for AUD pharmacotherapy development. These findings suggest that a wider range of early efficacy indicators and experimental paradigms be considered for Phase II testing of novel compounds.

Do hypothetical evaluations of alcohol related consequences change over time? Examining the influence of past and ongoing consequences.

OBJECTIVE: Despite experiencing alcohol-related consequences, college students continue to drink at high rates. Hypothetical evaluations of alcohol-related consequences (i.e., evaluations of where potential/hypothetical consequences lie on a spectrum from extremely positive to extremely negative) may contribute to the maintenance of drinking patterns among students. The purpose of the present study was to describe hypothetical evaluations in a sample of students mandated to an alcohol intervention, examine changes over time, and investigate the influence of both baseline and time-varying experienced consequences. METHOD: This study was a secondary data analysis from a longitudinal randomized controlled trial. Participants were 474 mandated students (Mage = 18.65; 55.5 % male, 77.6 % White). Students completed an initial baseline assessment of demographics, alcohol use, consequences, and hypothetical evaluations, and 3-month and 9-month follow-up assessments that included hypothetical evaluations and experienced consequences. RESULTS: Hierarchical linear modeling (HLM) analyses revealed significant change in hypothetical evaluations over time such that they became less negative. A piecewise model demonstrated that this change happened between baseline and 3-month, with no additional change between 3-month and 9-month. The experience of consequences at baseline did not significantly moderate changes in either time interval. Time-varying consequences also had no significant effect on same-timepoint hypothetical evaluations. CONCLUSIONS: This study is the first to examine changes in hypothetical evaluations over time among mandated college students. Counter to expectations, hypothetical evaluations became less negative at 3-month follow-up. Though preliminary, findings add to the understanding of hypothetical evaluations of alcohol-related consequences.

Young adults' change talk within brief motivational intervention in the emergency department and booster sessions is associated with a decrease in heavy drinking over 1 year.

OBJECTIVE: Investigate the effect of change talk (CT) within successive brief motivational interventions (BMIs) as a mechanism of change for alcohol use. METHOD: We conducted a secondary analysis of data from a randomized controlled trial in which 344 young adults (18-35 years old) admitted to a Swiss emergency department with alcohol intoxication received either BMI (N = 171) or brief advice (N = 173). Participants with a baseline audio-recorded BMI were included (N = 140; median age 23 [Q1-Q3: 20-27], 72.9% men). Up to three booster sessions by phone were offered at 1 week, 1 month, and 3 months. Percent CT and CT Average Strength were used as predictor variables. The outcome was the number of heavy drinking days (HDD) over the 30 days prior to research assessments at 1-, 3-, 6-, and 12-month follow-up. A latent growth curve modeling framework was first used to estimate predictor and outcome variable growth parameters (i.e., intercept and slope) over time, and then to regress HDD growth parameters on CT growth parameters. RESULTS: CT increased specifically from baseline to the 1-week booster session and thereafter remained stable. Higher baseline CT was associated with lower HDD at 1 month (Percent CT: b = -0.04, 95% confidence interval [-0.06, -0.01]; Average Strength: b = -0.99 [-1.67, -0.31]). An increase in CT from baseline to the 1-week booster session was related to a decrease in HDD from 1 month to 12 months (Percent CT: b = -0.08 [-0.14, -0.03]; Average Strength: b = -2.29 [-3.52, -1.07]). CONCLUSIONS: Both baseline CT and CT trajectory over the first week are meaningful predictors of HDD. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Does self-affirmation augment the effects of a mandated personalized feedback intervention? A randomized controlled trial with heavy drinking college students.

OBJECTIVE: Theory and evidence indicate that affirming the value of the self before exposure to a threatening message fosters more open-minded appraisal of message content. We predicted that college students mandated to a computer-delivered personalized feedback intervention (PFI) and who engaged in a self-affirmation (SA) exercise would demonstrate reduce drinking and consequences relative to those who received an attention control. METHOD: Participants were 484 undergraduates (age 18-24, 56% male, 78% White) mandated to participate in an alcohol intervention following a first-time alcohol policy violation. After a baseline assessment, each was randomized to SA (n = 256) or attention control (n = 227) prior to a computer-delivered PFI intervention. Posttest measures included an affirmation manipulation check; primary outcomes (past month weekly quantity, peak drinks, binge frequency, consequences) were assessed at 1-, 3-, 6-, 9-, and 12-month follow-ups. We used latent growth curve modeling to test study hypotheses. RESULTS: The SA exercise increased positive self-evaluation at posttest (p < .001). Overall reductions in drinking and consequences were observed at early follow-up (all p < .05), but the SA manipulation was not associated with intercept or slope factor differences in the models. Engaging in assessments during COVID restrictions was generally associated with reduced drinking and consequences. CONCLUSIONS: The SA exercise did not differentially affect trajectories of alcohol use and consequences, despite evidence that the exercise had the predicted effect on participant's self-evaluations. The lack of SA effects could be attributed to a nonthreatening PFI intervention that is generally accepted among mandated students. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Technical and relational process in MI sessions with a sample of Hispanic/Latinx adults who engage in heavy drinking: A latent growth mediation model.

The current study tests the Motivational Interviewing (MI) technical and relational hypotheses in a sample of Hispanic/Latinx adults (N = 276) who engage in heavy alcohol consumption. MI causal theory hypothesizes that therapist use of MI consistent skills (i.e., technical hypothesis) and embodiment of the MI Spirit (i.e., relational hypothesis) will elicit client change talk, which is a putative mechanism of positive client outcome after the session. We tested these associations in a rigorous parallel process latent growth curve mediation modeling framework. The data are from a completed randomized clinical trial of a culturally-adapted (CAMI) versus un-adapted MI targeting hazardous alcohol use and consequences. Results. The unconditional growth models for the mediator (i.e., proportion of change talk relative to sustain talk) and two study outcomes (i.e., percent of heavy drinking days; alcohol-related consequences) showed a linear effect over a 12-month period with a slower rate of growth at later timepoints. Contrary to expectations, the latent growth mediation models did not show relationships between MI-consistent skills (i.e., technical predictor) or latent MI Spirit (i.e., relational indicator) and the slope factor for proportion change talk. The slope factor for proportion change talk was also not associated with the slope factors for percent heavy drinking and consequences over follow-up. Conclusions. In this novel population for MI process analysis, the technical and relational hypotheses were not supported. Studies that are exploratory may be needed to further investigate the causal model in populations that are not often represented in MI process research.

Outcomes of a Brief Motivational Intervention for Heavy Alcohol Use in Racial or Ethnic Minority Compared to White Emerging Adults.

PURPOSE: This study used secondary data from a randomized controlled trial of a Brief Motivational Intervention (BMI) to examine whether Non-White participants had different treatment results compared to White participants. METHODS: The outcome variables of this study were divided into primary outcomes (heavy drinking and consequences associated with alcohol use) and secondary outcomes (cognitive variables such as motivation to change alcohol use, and behavioral variables, including protective behavioral strategies). Linear regression analyses were conducted with the PROCESS macro for SPSS, to test if race or ethnicity moderated the relationship between BMI and each treatment outcome. Data was collected at two time points, six weeks and three months after treatment. RESULTS: This study showed that race or ethnicity did not moderate treatment results for the four outcome variables. Additional within-group effect sizes were calculated for all racial and ethnic categories, showing that Hispanic/Latine and Black participants had larger effect sizes in all the outcome variables. DISCUSSION: The discussion examines the potential strength of Motivational Interviewing due to its client-centered spirit, which naturally allows for incorporating values and identity-based factors, such as culture, into the session. CONCLUSION: The results suggest similar BMI outcomes among White and Non-White emerging adults who engage in heavy drinking, potentially due to its client-centered approach. This is a preliminary study, and the results are therefore tentative.

Practice Makes Perfect: MSW Students Reflect on Skill-Based Teaching Methods in Clinical Social Work Education.

In the current focus-group study, we consider student experiences with and perceptions of teaching methods that involve practice observation, demonstration, and performance assessment and feedback (i.e., skill-based teaching methods). Focus groups included masters of social work students (N = 40) from six universities in the United States. Students were, on average, 34 years of age (range 21 to 58) with 75% female, 20% male, and two non-binary students. Students identified as White (50%), Latinx/Latine (20%), Black (12.5%), and multi-racial (12.2%). A framework-guided content analysis was used, and revealed four broad themes: 1) classroom-based opportunities for practice observation and feedback, 2) field-based opportunities for practice observation and feedback, 3) other methods such as standardized patient simulations and computer simulations, and 4) attitudes about these methods. Experiences with these methods were quite diverse with classroom-based role plays being the most common. Attitudes were generally positive, though lack of authenticity and performance anxiety were perceived as drawbacks. Student reflections on their experiences yielded several teaching recommendations specific to preparation, the nature of the simulated client role, and feedback.

Testing pharmacotherapies for alcohol use disorder with cue exposure paradigms: A systematic review and quantitative synthesis of human laboratory trial methodology.

Alcohol cue exposure is a widely used experimental paradigm for screening pharmacotherapies for alcohol use disorder (AUD). Medication-related reductions in cue-reactivity signal early efficacy and inform medications development. Yet, across trials, the design of cue exposure, parameter testing, and outcome reporting is heterogeneous. This systematic review is a quantitative synthesis of trial methodologies and effect size estimation for AUD medication-related craving and psychophysiological outcomes under the cue exposure paradigm. A PubMed search was conducted on January 3, 2022 based on identified pharmacotherapies for peer-reviewed articles reported in English. Study-level characteristics, including sample descriptors, paradigm design, analytic approach, and Cochrane Risk of Bias, along with descriptive statistics for cue-exposure outcomes, were coded by two independent raters. Study-level effect sizes were estimated for craving and psychophysiological outcomes separately and sample-level effect sizes were calculated for each medication. Thirty-six trials, comprising 1640 participants and testing 19 different medications satisfied eligibility criteria. All studies reported on biological sex (71% male participants on average). The exposure paradigms implemented used in vivo (n = 26), visual (n = 8), and audio script (n = 2) cues. Some trials included means for craving by medication condition in text (k = 7) or figures (k = 18). The quantitative synthesis included 63 effect sizes (craving kes = 47; psychophysiological kes = 16) from 28 unique randomized trials testing 15 medications for effects on cue reactivity. For cue-induced craving, eight medications (kes range: 1-12) demonstrated small-to-medium effects (Cohen's d range: |0.24-0.64|) compared to placebo, with individuals randomized to receive medication reporting lower craving following cue exposure. Recommendations are provided to promote further consilience, so that the utility of cue exposure paradigms can be maximized in the development of effective AUD pharmacotherapies. Future work should explore the predictive utility of medication-related reductions in cue-reactivity on clinical outcomes.

Are medication effects on subjective response to alcohol and cue-induced craving associated? A meta regression study.

RATIONALE: Alcohol administration and cue-reactivity paradigms are frequently used to screen for the initial efficacy of medications for alcohol use disorder (AUD). While medication effects on the primary outcomes for these paradigms are assumed to be qualitatively related, there is a critical lack of quantitative evidence to support this hypothesis. OBJECTIVES: The study aims to test the relationship between medication effect sizes on subjective response to alcohol administration and medication effect sizes for cue-induced craving to cue exposure, using meta-analysis. METHODS: Systematic literature searches were conducted to identify randomized trials, wherein AUD medications were tested using the alcohol administration and/or cue-reactivity paradigms. From these studies, descriptive statistics were collected to compute medication effect sizes on the primary outcomes for each respective paradigm. With medication as the unit of analysis, medication effect sizes in alcohol administration studies were compared with medication effect sizes in cue-reactivity studies using the Williamson-York regression which allows for meta-regression across independent samples. RESULTS: Medication effect sizes on alcohol-induced stimulation and alcohol-induced craving were not significantly associated with medication effect sizes on cue-induced alcohol craving (k stimulation = 10 medications, [Formula: see text] and k craving = 11 medications, [Formula: see text] (SE = 0.237), [Formula: see text]), respectively. Medication effect sizes on alcohol-induced sedation were significantly associated with medication effects on cue-induced craving (k = 10 medications, [Formula: see text] (SE = 0.258), [Formula: see text]), such that medications that increased alcohol-induced sedation were more likely to reduce cue-induced alcohol craving. CONCLUSIONS: With the exception of alcohol-induced sedation, there is little quantitative evidence of medication effects on subjective response domains measured during alcohol administration parallel medication effects on cue-induced alcohol craving. To provide additional context to the current study, future work should examine whether cue-reactivity findings predict clinical trial outcomes.

Who benefits from brief motivational intervention among young adults presenting to the emergency department with alcohol intoxication: A latent-class moderation analysis.

BACKGROUND: Research has not identified which patients optimally benefit from brief Motivational Interviewing (bMI) for heavy drinking when delivered to young adults in the Emergency Department (ED). METHODS: We conducted secondary analyses of data from a randomized controlled trial in which 344 young adults (18-35 years) presenting to the ED with alcohol intoxication received either bMI or Brief Advice (BA, control group). We used Latent Class Analysis to derive participants' profiles from baseline characteristics (i.e., sex, age, severity of alcohol use disorder, attribution of ED admission to alcohol use, importance, and confidence to change, cognitive discrepancy, anxiety, depression, and trait reactance). We then conducted a moderation analysis to assess the number of heavy drinking days at short-term (1-month) and long-term (12-month) follow-up using negative binomial regressions with interactions between the intervention and derived classes. RESULTS: Fit statistics indicated that a 4-class solution best fit the data. Class 3 (high severity, importance and discrepancy, and low confidence and anxiety) benefitted more from bMI than BA at short- and long-term follow-up than Class 1 (younger; lowest severity, importance, discrepancy, reactance, anxiety and depression, and highest confidence). Class 2 (older; highest severity, importance, discrepancy, reactance, anxiety and depression, and lowest confidence) also benefitted more from bMI than BA than did Class 1 at short-term follow-up. In these significant contrasts, Class 1 benefitted more from BA than bMI. There were no significant interactions involving Class 4 (more likely to be women; low severity; high levels of anxiety, depression, and reactance). CONCLUSIONS: This study identified the patient profiles that benefitted more from bMI than BA among nontreatment-seeking young adults who present intoxicated to the ED. The findings have implications for intervention design and argue for the importance of research aimed at developing intervention content tailored to patient profiles.

Mifepristone as a pharmacological intervention for stress-induced alcohol craving: A human laboratory study.

Preclinical and clinical work suggests that mifepristone may be a viable treatment for alcohol use disorder (AUD). This was a Phase 1/2, outpatient, cross-over, randomized, double-blind, placebo-controlled trial with non-treatment-seeking individuals with AUD (N = 32). We assessed safety, alcohol craving and consumption, after 1-week mifepristone 600 mg/day administration, in a human laboratory study comprised of a single oral yohimbine administration (32.4 mg), a cue-reactivity procedure and alcohol self-administration. Safety was monitored by adverse events and hemodynamic parameters, alcohol craving by alcohol craving questionnaire and cue-induced saliva output. During the alcohol self-administration, we assessed alcohol pharmacokinetics, subjective effects and consumption. Outcomes were assessed using Generalized Estimating Equations and mediation analysis. Mild-moderate adverse events were reported in both conditions. There was no statistically significant difference between mifepristone and placebo in alcohol pharmacokinetics and subjective effects. Furthermore, blood pressure increased only in the placebo condition after the stress-induced laboratory procedures. Mifepristone, compared to placebo, significantly reduced alcohol craving and increased cortisol levels. Mifepristone-induced cortisol increase was not a mediator of alcohol craving. Mifepristone, compared to placebo, did not reduce alcohol consumption in the laboratory or in a naturalistic setting. This study successfully translated a developed preclinical procedure to a human laboratory study, confirming the safety of mifepristone in people with AUD and providing evidence to its role in reducing alcohol craving under stress procedures. The lack of effects on alcohol drinking may be related to the selection of non-treatment seekers and suggests future treatment-oriented trials should investigate mifepristone in people with AUD.

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.

Mifepristone as a pharmacological intervention for stress-Induced alcohol craving: a translational crossover randomized trial.

Preclinical and clinical work suggests that mifepristone (glucocorticoid receptor antagonist), may be a viable treatment for alcohol use disorder (AUD). The aim of this work was to translate our preclinical mifepristone study using yohimbine (α2 receptor antagonist) stress-induced reinstatement of alcohol-seeking to a clinical setting. This was a Phase 1/2, outpatient, cross-over, randomized, double-blind, placebo-controlled trial with non-treatment-seeking individuals with AUD ( N =32). We investigated the safety, alcohol craving and consumption after oral administration of mifepristone (600mg daily for a week) in a human laboratory study comprised of administration of yohimbine in a cue-reactivity procedure and alcohol self-administration. Outcomes were assessed using Generalized Estimating Equations and mediation and moderation analyses assessed mechanisms of action and precision medicine targets. We did not observe serious adverse events related to the study drugs or study procedure and mild to moderate non-serious adverse events were reported by both study conditions. Also, there was no statistically-significant difference between the mifepristone and placebo in the hemodynamic response, alcohol subjective effects and pharmacokinetics parameters. Mifepristone significantly reduced alcohol craving and increased cortisol levels. Mifepristone-induced cortisol increase was not a mediator of alcohol craving. Moderation analysis with family history density of AUD (FHDA) and mifepristone, suggested that reduced craving was present in individuals with low , but not high FHDA. Mifepristone, compared to placebo, did not reduce alcohol consumption in the laboratory or in a naturalistic setting. This study successfully translated a preclinical paradigm to a human laboratory study confirming safety, tolerability and efficacy of mifepristone in an alcohol paradigm. Mediation analysis showed that the effect of mifepristone on craving was not related to mifepristone-induced increases in cortisol and moderation of FHDA suggested the importance of evaluating AUD endophenotypes for pharmacotherapies. Clinical trial registration: Clinicaltrials.gov ; NCT02243709. IND/FDA: 121984, mifepristone and yohimbine (Holder: Haass-Koffler).

The role of the relational context and therapists' technical behaviors in brief motivational interviewing sessions for heavy alcohol consumption: Findings from a sample of Latinx adults.

INTRODUCTION: Motivational interviewing (MI) theory and process research highlights the role of therapist technical and relational behaviors in predicting client in-session statements for or against behavior change (i.e., change and sustain talk, respectively). These client statements, in turn, have been shown to predict intervention outcomes. The current study examines sequential associations between therapist behaviors and client change and sustain talk in a sample of Latinx individuals who engage in heavy alcohol consumption. DATA: Data are from a completed randomized clinical trial of a culturally adapted (CAMI) versus unadapted MI targeting alcohol use and consequences among Latinx individuals. METHOD: The study collected observational coding data with the Motivational Interviewing Skill Code (MISC 2.5, i.e., therapist behaviors and global ratings) and the Client Language Assessment - Proximal/Distal (CLA-PD, i.e., client language). Frequentist and Bayesian sequential analyses examined the relationship among nine different categories of therapist behaviors and three different categories of client language (i.e., change talk, sustain talk, neutral). We examined odds ratios and conditional probabilities for the direction, magnitude, and significance of the association between the use of MI technical behaviors and subsequent client statements about change. The study compared these same transitional associations between low/average (i.e., <4) and high (i.e., ≥4) MI Spirit sessions. RESULTS: The pattern of results was replicated across both analytic frameworks. Questions and reflections about change talk versus sustain talk versus neutral statements showed greater odds of predicting the intended client response (i.e., change talk, sustain talk, neutral, respectively) compared to other possible client responses. Conditional probabilities for these transitions were high, ranging from 0.55 to.88. The magnitude of certain technical transitions significantly differed between low/average and high MI Spirit sessions. CONCLUSIONS: Analyses supported the hypothesized associations between therapist use of technical MI behaviors and client change language within this Latinx sample. Analyses of MI Spirit as a moderator of these transitions showed partial support.

Change talk subtypes as predictors of alcohol use following brief motivational intervention.

OBJECTIVE: To examine the relative importance of client change language subtypes as predictors of alcohol use following motivational interviewing (MI). METHOD: Participants were 164 heavy drinkers (57.3% female, Mage = 28.5 years, 13.4% Hispanic/Latinx, 82.9% White) recruited during an emergency department visit who received MI for alcohol and human immunodeficiency virus/sexual risk in a randomized-controlled trial. MI sessions were coded with the motivational interviewing skill code (MISC) and the generalized behavioral intervention analysis system (GBIAS). Variable importance analyses used targeted maximum likelihood estimation to rank order change language subtypes defined by these systems as predictors of alcohol use over 9 months of follow-up. RESULTS: Among GBIAS change language subtypes, higher sustain talk (ST) around change planning was ranked the most important predictor of drinks per week (b = -5.57, 95% CI [-8.11, -3.02]) and heavy drinking days (b = -2.07, 95% CI [-3.17, -0.98]); this talk reflected (a) rejection of alcohol abstinence as a desired change goal, (b) rejection of specific change strategies, or (c) discussion of anticipated challenges in changing drinking. Among MISC change language subtypes, higher ST around taking steps-reflecting recent escalations in drinking described by a small minority of participants-was ranked the most important predictor of drinks per week (b = 22.71, 95% CI [20.29, 25.13]) and heavy drinking days (b = -2.45, 95% CI [1.68, 3.21]). CONCLUSIONS: Results challenge the assumption that all ST during MI is a negative prognostic indicator and highlight the importance of the context in which change language emerges. (PsycInfo Database Record (c) 2023 APA, all rights reserved).