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.

Study Protocol for the Healing Opioid Misuse and Pain Through Engagement Trial: Integrated Treatment for Individuals With Co-occurring Chronic Pain and Opioid Use Disorder.

Chronic pain and opioid use disorder (OUD) are public health crises and their co-occurrence has led to further complications and public health impacts. Provision of treatments for comorbid chronic pain and OUD is paramount to address these public health crises. Medications for OUD (MOUD) are gold standard treatments for OUD that have also demonstrated benefit in pain management. However, clinics that provide MOUD for chronic pain or OUD often lack behavioral treatments to address the challenges experienced by individuals with both conditions. Developing and implementing a behavioral treatment that complements MOUD may better equip clinics to provide comprehensive care to the growing proportion of clients who present with comorbid chronic pain and OUD. In the Healing Opioid misuse and Pain through Engagement (HOPE) Trial, we are using an effectiveness-implementation hybrid design to examine the benefits of an integrated behavioral treatment and to determine the feasibility of implementing the integrated treatment into clinics that provide MOUD. The treatment integrated 2 evidence-based treatments-Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention-to target the emotional, behavioral, and physiological sequelae of OUD and chronic pain. Implementation feasibility will include assessing changes in implementation readiness and identifying facilitators and barriers to implementing the integrated treatment among all personnel employed in clinics that provide MOUD. This commentary offers an overview of the study and design and details adaptations we made to our study protocol, based largely on clinic personnel time constraints and variable clinic procedures during the COVID-19 pandemic.

Patterns of drinking behavior around a treatment episode for alcohol use disorder: Predictions from pre-treatment measures.

BACKGROUND: Alcohol use disorder (AUD) has been described as a chronic disease given the high rates that affected individuals have in returning to drinking after a change attempt. Many studies have characterized predictors of aggregated alcohol use (e.g., percent heavy drinking days) following treatment for AUD. However, to inform future research on predicting drinking as an AUD outcome measure, a better understanding is needed of the patterns of drinking that surround a treatment episode and which clinical measures predict patterns of drinking. METHODS: We analyzed data from the Project MATCH and COMBINE studies (MATCH: n = 1726; 24.3% female, 20.0% non-White; COMBINE: n = 1383; 30.9% female, 23.2% non-White). Daily drinking was measured in the 90 days prior to treatment, 90 days (MATCH) and 120 days (COMBINE) during treatment, and 365 days following treatment. Gradient boosting machine learning methods were used to explore baseline predictors of drinking patterns. RESULTS: Drinking patterns during a prior time period were the most consistent predictors of future drinking patterns. Social network drinking, AUD severity, mental health symptoms, and constructs based on the addiction cycle (incentive salience, negative emotionality, and executive function) were associated with patterns of drinking prior to treatment. Addiction cycle constructs, AUD severity, purpose in life, social network, legal history, craving, and motivation were associated with drinking during the treatment period and following treatment. CONCLUSIONS: There is heterogeneity in drinking patterns around an AUD treatment episode. This study provides novel information about variables that may be important to measure to improve the prediction of drinking patterns during and following treatment. Future research should consider which patterns of drinking they aim to predict and which period of drinking is most important to predict. The current findings could guide the selection of predictor variables and generate hypotheses for those predictors.

An open trial of rolling admission mindfulness-based relapse prevention (Rolling MBRP): feasibility, acceptability, dose-response relations, and mechanisms.

Mindfulness-based relapse prevention (MBRP) is an effective treatment for substance use disorders (SUD). However, evidence is primarily based on studies of closed groups, and few studies support flexible formats of MBRP, such as rolling groups. This nonrandomized, open trial evaluated feasibility, acceptability, dose-response relations, and mechanisms of rolling admission MBRP ("Rolling MBRP") offered as part of short-term residential treatment for SUD. Rolling MBRP was developed prior to the trial through an iterative process over several years. Participants included 109 adults (46% female, 74.3% racial/ethnic minorities, mean age=36.40). Rolling MBRP was offered to all patients in the program 2x/week and attendance was tracked. Outcomes were craving, self-efficacy, mental health, mindfulness, and self-compassion at discharge. Self-reported out-of-session mindfulness practice was examined as a mediator of attendance-outcome relations. Analyses involved multiple regression and mediation models. Feasibility was demonstrated by good attendance rates. Acceptability was demonstrated by high engagement in mindfulness practice and high satisfaction ratings. Total sessions attended did not predict outcomes at discharge. However, attending 2+ sessions (versus 1 or none) significantly predicted better mental health and higher mindfulness at discharge, and these effects were mediated by informal and formal mindfulness practice. Total sessions attended had significant indirect effects on craving, self-compassion, mindfulness, and mental health, via mindfulness practice. Results support the feasibility and acceptability of Rolling MBRP and suggest mindfulness practice may be a key mechanism driving effects of MBRP on other key mechanisms during the recovery process, such as decreased craving and improved mental health.

Consumption outcomes in clinical trials of alcohol use disorder treatment: Consideration of standard drink misestimation.

Background. The Food and Drug Administration recently added a new clinical endpoint for evaluating the efficacy of alcohol use disorder (AUD) treatment that is more inclusive of treatment goals besides abstinence: no heavy drinking days (NHDD). However, numerous critiques have been noted for such binary models of treatment outcome. Further, there is mounting evidence that participants inaccurately estimate the quantities of alcohol they consume during drinking episodes (i.e., drink size misestimation), which may be particularly problematic when using a binary criterion (NHDD) compared to a similar, continuous alternative outcome variable: percent heavy drinking days (PHDD). Yet, the impact of drinking misestimation on binary (e.g., NHDD) versus continuous outcome variables (e.g., PHDD) has not been studied. Objectives. Using simulation methods, the present study examined the potential impact of drink size misestimation on NHDD and PHDD. Methods. Data simulations were based on previously published findings of the amount of error in how much alcohol is actually poured when estimating standard drinks. We started with self-reported daily drinking data from COMBINE study participants with complete data (N = 888; 68.1% male), then simulated inaccuracy in those estimations based on literature on standard drink size misestimation. Results. Clinical trial effect sizes were consistently lower for NHDD than for PHDD. Drink size misestimation further lowered effect sizes for NHDD and PHDD. Conclusions. Drink size misestimation may lead to inaccurate conclusions about drinking outcomes and the comparative effectiveness of AUD treatments, including inflated type-II error rates, particularly when treatment "success" is defined by binary outcomes such as NHDD.

Predictive value of non-consumption outcome measures in alcohol use disorder treatment.

BACKGROUND AND AIMS: For decades, researchers have called for the systematic inclusion of non-consumption outcomes, such as alcohol-related consequences and temptation/craving, in addition to consumption outcomes (e.g. percentage of days abstinent) to evaluate alcohol use disorder (AUD) treatment efficacy. However, Food and Drug Administration (FDA) guidelines for alcohol medications development suggest that non-consumption outcomes may be insensitive to changes that occur within AUD treatment trial assessment windows, although this has never been directly tested. We aimed to measure the predictive value of diagnostically related, non-consumption measures of AUD treatment effects. METHODS: Pre- to post-treatment effect sizes were examined. Logistic regression analyses were used to test the predictive value of non-consumption outcome measures that were administered in the COMBINE (Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence) Study and Project MATCH (Matching Alcoholism Treatment to Client Heterogeneity) in detecting 12-month outcomes following treatment. RESULTS: Pre- to post-treatment effect sizes suggested that non-consumption measures changed during the course of treatment; effect sizes for temptation/craving, self-efficacy, consequences and consumption variables were mostly medium to large (medium effect sizes were 0.2 < dz < 0.8, large effect sizes were dz > 0.8). The regression results indicated temptation/craving and self-efficacy predicted 12-month drinking outcomes in COMBINE and MATCH, and drinking consequences predicted 12-month drinking outcomes in COMBINE. CONCLUSIONS: Self-report measures of temptation and alcohol craving can change as a result of alcohol dependence treatment and can predict drinking outcomes.

Profiles of recovery from alcohol use disorder at three years following treatment: can the definition of recovery be extended to include high functioning heavy drinkers?

BACKGROUND AND AIMS: Recovery from alcohol use disorder (AUD) is often narrowly defined by abstinence from alcohol and improvements in functioning (e.g. mental health, social functioning, employment). This study used latent profile analysis to examine variability in recovery outcomes, defined by alcohol use, alcohol-related problems and psychosocial functioning at 3 years following treatment. Secondary analysis investigated pre-treatment, post-treatment and 1- and 3-year post-treatment covariate predictors of the latent profiles. DESIGN: Secondary analysis of data from a randomized clinical trial. SETTING: United States. PARTICIPANTS: We used data from the out-patient arm of Project MATCH (n = 806; 29.7% female, 22.2% non-white). MEASUREMENTS: Recovery was defined by latent profile analyses including measures of psychosocial functioning and life satisfaction (Psychosocial Functioning Inventory), unemployment and mental health (Addiction Severity Index), alcohol and other drug use (Form 90) and alcohol-related consequences (Drinker Inventory of Consequences) 3 years following treatment. Mixture modeling was used to examine correlates of profiles. FINDINGS: We identified four profiles at 3 years following treatment: (1) poor functioning frequent heavy drinkers, (2) poor functioning infrequent heavy drinkers, (3) high functioning occasional heavy drinkers and (4) high-functioning infrequent non-heavy drinkers. There were relatively few differences on indicators of functioning and treatment-related variables between the high functioning infrequent non-heavy drinkers and the high-functioning occasional heavy drinkers, other than high-functioning occasional heavy drinkers having lower alcohol dependence severity [odds ratio (OR) = 0.94, 95% confidence interval (CI) = 0.90, 0.98], fewer post-treatment coping skills (OR = 0.54, 95% CI = 0.32, 0.90) and lower 3-year post-treatment abstinence self-efficacy (OR = 0.37, 95% CI = 0.28, 0.49) and Alcoholics Anonymous (AA) involvement (OR = 0.87, 95% CI = 0.85, 0.99). The two high-functioning profiles showed the greatest improvements in functioning from baseline through the 3-year follow-up, whereas the low-functioning profiles showed the least amount of improvement. High-functioning occasional heavy drinkers had higher purpose in life than the poor-functioning profiles. CONCLUSIONS: Some individuals who engage in heavy drinking following treatment for alcohol use disorder may function as well as those who are mostly abstinent with respect to psychosocial functioning, employment, life satisfaction and mental health.

Abstinence and low risk drinking during treatment: Association with psychosocial functioning, alcohol use, and alcohol problems 3 years following treatment.

Abstinence from alcohol is often considered a critical element of recovery from alcohol use disorder. Yet, low risk drinking may be more desirable for some patients. There is mixed literature on whether low risk drinking is achievable and stable. Low risk drinking outcomes during treatment and outcomes 3 years after treatment were examined using data from the outpatient arm in Project MATCH (n = 877). Drinking outcomes were defined by repeated measures latent class analysis of weekly abstinence, low risk drinking days (<4/5 drinks for women/men), and heavy drinking days (≥4/5 drinks for women/men) during 12 weeks of treatment. Functioning outcome measures included psychosocial functioning, alcohol use, and alcohol-related consequences. Mixture modeling was used to examine the association between drinking classes and functioning outcomes. We identified 7 classes based on drinking during treatment: persistent heavy drinking, abstinence to heavy drinking, abstinence and heavy drinking, heavy drinking to mostly abstinent, low risk and heavy drinking, abstinence and low risk drinking, and abstinence. As compared with heavier drinkers, individuals who achieved mostly abstinence or low risk drinking, even with some heavy drinking episodes during treatment, had significant improvements in alcohol use, alcohol-related consequences, and psychosocial functioning 3 years after treatment. Those who were mostly abstinent or engaged in low risk drinking during treatment did not differ on any outcomes at 3 years after treatment. Findings indicate that low risk drinking is achievable for some individuals during treatment and that improvement in functioning among low risk drinkers can be observed at 3 years after treatment. (PsycINFO Database Record

Revisiting the Drinker Inventory of Consequences: An extensive evaluation of psychometric properties in two alcohol clinical trials.

Alcohol-related consequences are linked directly to the diagnostic criteria for alcohol use disorder (AUD). However, alcohol consumption outcome variables (e.g., percent days abstinent, heavy drinking days) remain the dominant outcome in AUD treatment research. Two reasons AUD treatment researchers have not shifted to include alcohol-related consequences as a primary outcome may be that previous studies have failed to provide convincing evidence of (1) the psychometric properties of measures of alcohol-related consequences, and (2) whether consequences measures are sensitive to change following treatment. The present study directly addresses these two concerns via psychometric evaluation and sensitivity/specificity testing of the Drinker Inventory of Consequences (DrInC; Miller, Tonigan, & Longabaugh, 1995) in two of the largest multisite clinical trials ever conducted (COMBINE Study, Anton, et al., 2006; and Project MATCH, Project MATCH Research Group, 1997). Results indicated that the five subscales commonly used for the DrInC had poor construct validity and were noninvariant across time. A newly developed three-factor model consisting of mild, moderate, and severe consequences had excellent psychometrics, including good internal consistency reliability, construct validity, and measurement invariance over time. The three-factor model of the DrInC was also sensitive and specific for detecting consumption outcomes in both COMBINE and MATCH and had convergent validity with measures of consumption and wellbeing. In conclusion, the three-factor DrInC may be a useful tool for defining AUD treatment success in a clinically meaningful way that aligns with diagnostic criteria. (PsycINFO Database Record

"Being able to speak": What individuals in jail perceived as helpful about participating in alcohol-related brief interventions.

BACKGROUND: A significant proportion of individuals within the criminal justice system meet criteria for a substance use disorder. Treatments for individuals who are incarcerated with substance use disorders show minimal to no benefit on postrelease outcomes, suggesting a need to improve their effectiveness, particularly those that can be delivered in a brief format. The purpose of this study was to describe what individuals in jail with substance use disorders perceived as being helpful about 2 brief alcohol-focused interventions, which can be used to inform future treatments with this population. METHODS: Data came from a parent study where 58 individuals in jail with substance use disorders received either a motivational or educational intervention focused on alcohol and other substance use and then completed a questionnaire assessing what was most and least helpful about the interventions. Qualitative responses were coded using a grounded theory approach. RESULTS: Results indicated that participants from both interventions reported that receiving individualized attention and talking one-on-one with someone was helpful, and that the interventions were encouraging and elicited hope. There also were specific components from each intervention that participants said were beneficial, including the opportunity to discuss plans for postrelease and to learn about addiction from psychoeducational videos. Participants noted areas for improving future interventions. Suggestions from participants were to offer tangible resources upon release, make session lengths flexible, and reduce assessment burden during research interviews. CONCLUSIONS: Findings align with established approaches for working with marginalized groups, namely, community-based participatory research methods and shared decision-making models for treatment. This study provided a voice to individuals in jail with substance use disorders, a group often underrepresented in the literature, and may offer an initial look at how to improve treatments for this high-risk population.

Viability of the World Health Organization quality of life measure to assess changes in quality of life following treatment for alcohol use disorder.

PURPOSE: Quality of life is an outcome often examined in treatment research contexts such as biomedical trials, but has been studied less often in alcohol use disorder (AUD) treatment. The importance of considering QoL in substance use treatment research has recently been voiced, and measures of QoL have been administered in large AUD treatment trials. Yet, the viability of popular QoL measures has never been evaluated in AUD treatment samples. Accordingly, the present manuscript describes a psychometric examination of and prospective changes in the World Health Organization Quality of Life measure (WHOQOL-BREF) in a large sample (N = 1383) of patients with AUD recruited for the COMBINE Study. METHODS: Specifically, we examined the construct validity (via confirmatory factor analyses), measurement invariance across time, internal consistency reliability, convergent validity, and effect sizes of post-treatment changes in the WHOQOL-BREF. RESULTS: Confirmatory factor analyses of the WHOQOL-BREF provided acceptable fit to the current data and this model was invariant across time. Internal consistency reliability was excellent (α > .9) for the full WHOQOL-BREF for each timepoint; the WHOQOL-BREF had good convergent validity, and medium effect size improvements were found in the full COMBINE sample across time. CONCLUSIONS: These findings suggest that the WHOQOL-BREF is an appropriate measure to use in samples with AUD, that the WHOQOL-BREF scores may be examined over time (e.g., from pre- to post-treatment), and the WHOQOL-BREF may be used to assess improvements in quality of life in AUD research.

Identifying "Hitting Bottom" Among Individuals with Alcohol Problems: Development and Evaluation of the Noteworthy Aspects of Drinking Important to Recovery (NADIR).

BACKGROUND: Alcohol use disorder (AUD) is a costly public health concern; yet, many individuals with AUD never receive formal treatment. Prior studies have identified that "hitting bottom" may be an important factor in seeking treatment for AUD) and the notion that "hitting bottom" is necessary for recovery is commonly portrayed in the popular media. Yet, "hitting bottom" has never been formally operationalized. OBJECTIVES: The present article aimed to operationalize "hitting bottom." METHODS: A multiphase process was used to develop a measure of hitting bottom among individuals experiencing alcohol problems: The Noteworthy Aspects of Drinking Important to Recovery (NADIR). Psychometric evaluation of the measure was conducted using online data collected from individuals who identified as moderate to heavy drinkers (N = 597). RESULTS: The NADIR included five lower-order dimensions and one higher-order dimension ("hitting bottom"), had strong concurrent validity with measures of alcohol use severity and alcohol-related problems, and was found to have excellent internal consistency reliability (α > 0.90). An overall summary score on the NADIR of 50+ (factor scores>0) differentiated individuals who had previously sought treatment for AUD and reported more excessive alcohol use compared to those with no treatment history and lower levels of alcohol use. Thus, the NADIR with a cutoff of 50 may be a good starting point for future researchers to test as a method to identify individuals who have hit bottom. Conclusions/Importance: The NADIR provides a viable operational definition of hitting bottom. Future research should evaluate the predictive validity of the NADIR.

Who achieves low risk drinking during alcohol treatment? An analysis of patients in three alcohol clinical trials.

BACKGROUND AND AIMS: There is evidence that low-risk drinking is possible during the course of alcohol treatment and can be maintained following treatment. Our aim was to identify characteristics associated with low-risk drinking during treatment in a large sample of individuals as they received treatment for alcohol dependence. DESIGN: Integrated analysis of data from the Combined Pharmacotherapies and Behavioral Intervention (COMBINE) study, Project MATCH (Matching Alcoholism Treatments to Client Heterogeneity) and the United Kingdom Alcohol Treatment Trial (UKATT) using repeated-measures latent class analysis to identify patterns of drinking and predictors of low-risk drinking patterns during treatment. SETTING: United States and United Kingdom. PARTICIPANTS: Patients (n = 3589) with alcohol dependence receiving treatment in an alcohol clinical trial were primarily male (73.0%), white (82.0%) and non-married (41.7%), with an average age of 42.0 (standard deviation = 10.7). MEASUREMENTS: Self-reported weekly alcohol consumption during treatment was assessed using the Form-90 and validated with biological verification or collateral informants. FINDINGS: Seven patterns of drinking during treatment were identified: persistent heavy drinking (18.7% of the sample), increasing heavy drinking (9.6%), heavy and low-risk drinking (6.7%), heavy drinking alternating with abstinence (7.9%), low-risk drinking (6.8%), increasing low-risk drinking (10.5%) and abstinence (39.8%). Lower alcohol dependence severity and fewer drinks per day at baseline significantly predicted low-risk drinking patterns [e.g. each additional drink prior to baseline predicted a 27% increase in the odds of expected classification in heavy drinking versus low-risk drinking patterns; odds ratio = 1.27 (95% confidence interval (CI) = 1.10, 1.47, P = 0.002]. Greater negative mood and more heavy drinkers in the social network were significant predictors of expected membership in heavier drinking patterns. CONCLUSIONS: Low-risk drinking is achievable for some individuals as they undergo treatment for alcohol dependence. Individuals with lower dependence severity, less baseline drinking, fewer negative mood symptoms and fewer heavy drinkers in their social networks have a higher probability of achieving low-risk drinking during treatment.

How Much Is Too Much? Patterns of Drinking During Alcohol Treatment and Associations With Post-Treatment Outcomes Across Three Alcohol Clinical Trials.

OBJECTIVE: This secondary data analysis examined patterns of drinking during alcohol treatment and associated drinking outcomes during the first year following treatment. The goal was to provide clinicians with guidance on which patients may be most at risk for negative long-term outcomes based on drinking patterns during treatment. METHOD: This study was an analysis of existing data (N = 3,851) from three randomized clinical trials for alcohol use disorder: the COMBINE Study (n = 1,383), Project MATCH (n = 1,726), and the United Kingdom Alcohol Treatment Trial (n = 742). Indicators of abstinence, non-heavy drinking, and heavy drinking (defined as 4/5 or more drinks per day for women/men) were examined during each week of treatment using repeated-measures latent class analysis. Associations between drinking patterns during treatment and drinking intensity, drinking consequences, and physical and mental health 12 months following intake were examined. RESULTS: Seven drinking patterns were identified. Patients who engaged in persistent heavy drinking throughout treatment and those who returned to persistent heavy drinking during treatment had the worst long-term outcomes. Patients who engaged in some heavy drinking during treatment had better long-term outcomes than persistent heavy drinkers. Patients who reported low-risk drinking or abstinence had the best long-term outcomes. There were no differences in outcomes between low-risk drinkers and abstainers. CONCLUSIONS: Abstinence, low-risk drinking, or even some heavy drinking during treatment are associated with the best long-term outcomes. Patients who are engaging in persistent heavy drinking are likely to have the worst outcomes and may require a higher level of care.

The search for an elusive cutoff remains: Problems of binary classification of heavy drinking as an endpoint for alcohol clinical trials.

BACKGROUND: To examine whether a clinically meaningful alcohol consumption cutoff can be created for clinical samples, we used receiver operator characteristic (ROC) curves to derive gender-specific consumption cutoffs that maximized sensitivity and specificity in the prediction of a wide range of negative consequences from drinking. METHODS: We conducted secondary data analyses using data from two large clinical trials targeting alcohol use disorders: Project MATCH (n=1726) and COMBINE (n=1383). RESULTS: In both studies, we found that the ideal cutoff for men and women that maximized sensitivity/specificity varied substantially both across different alcohol consumption variables and alcohol consequence outcomes. Further, the levels of sensitivity/specificity were poor across all consequences. CONCLUSIONS: These results fail to provide support for a clinically meaningful alcohol consumption cutoff and suggest that binary classification of levels of alcohol consumption is a poor proxy for maximizing sensitivity/specificity in the prediction of negative consequences from drinking. Future research examining consumption-consequence associations should take advantage of continuous measures of alcohol consumption and alternative approaches for assessing the link between levels of consumption and consequences (e.g., ecological momentary assessment). Clinical researchers should consider focusing more directly on the consequences they aim to reduce instead of relying on consumption as a proxy for more clinically meaningful outcomes.

Questioning the validity of the 4+/5+ binge or heavy drinking criterion in college and clinical populations.

BACKGROUND AND AIMS: The terms 'binge drinking' and 'heavy drinking' are both operationalized typically as 4+/5+ standard drinks per occasion for women/men, and are used commonly as a proxy for non-problematic (<4/<5) versus problematic (4+/5+) drinking in multiple research contexts. The Food and Drug Administration in the United States recently proposed the 4+/5+ criterion as a primary efficacy end-point in their guidance for trials examining new medications for alcohol use disorders (AUDs). Internationally, similar cut-offs have been proposed, with the European Medicines Agency having identified reductions in the number of heavy drinking days (defined as 40/60 g pure alcohol in women/men) as a primary end-point for efficacy trials with a harm reduction goal. ANALYSIS AND EVIDENCE: We question the validity of the 4+/5+ cut-off (and other similar cut-offs) on multiple accounts. The 4+/5+ cut-off has not been shown to have unique predictive validity or clinical utility. The cut-off has been created based on retrospective self-reports and its use demonstrates ecological bias. Given strong evidence that the relationship between alcohol consumption and problems related to drinking is at least monotonic, if not linear, there is little existing evidence to support the 4+/5+ cut-off as a valid marker of problematic alcohol use. CONCLUSIONS: There is little empirical evidence for the 4+/5+ standard drinks per occasion threshold for 'binge' or 'heavy' drinking in indexing treatment efficacy. Further consideration of an appropriate threshold seems to be warranted.

Client Evaluation of Treatment for Alcohol Use Disorder in COMBINE.

Practitioners and researchers across disciplines have been interested in identifying variables that act as indicators of treatment success or failure and one straightforward approach to measuring treatment success is to assess client satisfaction with treatment. Existing measures of treatment satisfaction do not address the specific aspects relevant to alcohol use disorder (AUD) treatment. Researchers in the COMBINE Study developed a new measure of treatment satisfaction to assess satisfaction in AUD treatment: The Evaluation of Treatment (EOT) measure. The aims of the present study were to examine the factor structure of items from the EOT measure and to examine the association between the EOT measure and other measures of client engagement, as well as AUD treatment outcomes. We also extended the model to test for possible mediation effects of treatment evaluation on the relationship between client treatment engagement components and AUD treatment outcomes. Confirmatory factor analyses indicated a 6-factor model with a higher order treatment satisfaction factor provided an excellent fit to the data (χ2 (246)=499.44, p<0.001, CFI=0.99, TLI=0.98, RMSEA =0.040 (90% CI: 0.035, 0.045). Overall, the latent factor of treatment satisfaction was significantly associated with client engagement predictors and treatment evaluation significantly mediated the associations between both working alliance and treatment expectations in the prediction of alcohol-related problems and global severity. Findings suggest that client evaluations of treatment play a substantial role in predicting AUD treatment outcomes and should be considered in future treatment and research.

Association between physical pain and alcohol treatment outcomes: The mediating role of negative affect.

OBJECTIVE: Physical pain and negative affect have been described as risk factors for alcohol use following alcohol treatment. The current study was a secondary analysis of 2 clinical trials for alcohol use disorder (AUD) to examine the associations between pain, negative affect and AUD treatment outcomes. METHOD: Participants included 1,383 individuals from the COMBINE Study (COMBINE Pharmacotherapies and Behavioral Interventions for Alcohol Dependence; COMBINE Study Research Group, 2003; 31% female, 23% ethnic minorities, average age = 44.4 [SD = 10.2]), a multisite combination pharmacotherapy and behavioral intervention study for AUD in the United States, and 742 individuals from the United Kingdom Alcohol Treatment Trial (UKATT Research Team, 2001; 25.9% female, 4.4% ethnic minorities, average age = 41.6 [SD = 10.1]) a multisite behavioral intervention study for AUD in the United Kingdom. The Form-90 was used to collect alcohol use data, the Short Form Health Survey and Quality of Life measures were used to assess pain, and negative affect was assessed using the Brief Symptom Inventory (COMBINE) and the General Health Questionnaire (UKATT). RESULTS: Pain scores were significantly associated with drinking outcomes in both datasets. Greater pain scores were associated with greater negative affect and increases in pain were associated with increases in negative affect. Negative affect significantly mediated the association between pain and drinking outcomes and this effect was moderated by social behavior network therapy (SBNT) in the UKATT study, with SBNT attenuating the association between pain and drinking. CONCLUSION: Findings suggest pain and negative affect are associated among individuals in AUD treatment and that negative affect mediated pain may be a risk factor for alcohol relapse.