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Objective: The Alcohol Addiction Research Domain Criteria (AARDoC) is an organizational framework for assessing heterogeneity in addictive disorders organized across the addiction cycle domains of incentive salience, negative emotionality, and executive functioning and may have benefits for precision medicine. Recent work found pretreatment self-report items mapped onto the addiction cycle domains and predicted 1- and 3-year alcohol use disorder treatment outcomes. Given the potential utility of the addiction cycle domains for predicting relevant treatment outcomes, this study sought to evaluate the longitudinal measurement invariance of the domains. Method: We conducted a secondary analysis of individuals with alcohol use disorder (n = 1,383, 30.9% female, 76.8% non-Hispanic White, 11.2% Hispanic) who participated in the COMBINE study. Eleven items assessed at pre- and posttreatment were included in exploratory structural equation modeling (ESEM) and longitudinal invariance analyses. Results: The pre- and posttreatment ESEM models had factor loadings consistent with the three addiction cycle domains and fit the data well. The ESEM factor structure was invariant from pre- to posttreatment (representing configural invariance) and metric invariance (factor loadings) was largely supported, but analyses failed to support scalar invariance (item-level thresholds) of the addiction cycle domains. Conclusions: A three-factor structure representing addiction cycle domains can be modeled using brief self-report measures pre- and posttreatment. Individuals demonstrated a downward shift in the level of item endorsement, indicating improvement with treatment. Although this 11-item measure might be useful at baseline for informing treatment decisions, results indicate the need to exercise caution in comparing the addiction cycle domains pre- to posttreatment within persons. Public Health Significance Statement: The addiction cycle domains of reward/incentive salience, relief/negative emotionality, and executive functioning, which are based on a neurobiological model of alcohol use disorder, may have clinical utility in predicting alcohol use disorder treatment response and recovery outcomes, but more work is needed before domain scores can be used to assess changes within individuals across time. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to evaluate the validity of World Health Organization (WHO) risk drinking level reductions as meaningful endpoints for clinical practice and research. This study examined whether such reductions were associated with a lower likelihood of a current alcohol use disorder (AUD) diagnosis and fewer AUD criteria. Methods: We conducted a secondary data analysis to address these objectives using data from a multisite randomized controlled trial of gabapentin enacarbil extended release in treating moderate to severe AUD among adults (N = 346). Participants received gabapentin enacarbil extended release or placebo for 6 months. The timeline follow-back was used to assess WHO risk drinking level reductions, and the Mini-International Neuropsychiatric Interview was used to assess Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) AUD diagnosis and criteria at baseline (past year) and end of treatment (past month). Results: Most participants (80.1%) achieved at least a 1-level reduction in the WHO risk drinking levels from baseline to end of treatment, and nearly half of participants (49.8%) achieved at least a 2-level reduction. At least a 1-level reduction or at least a 2-level reduction in WHO risk drinking level predicted lower odds of an active AUD diagnosis (1-level: odds ratio, 0.74 [95% confidence interval (CI), 0.66–0.84]; 2-level: odds ratio, 0.71 [95% CI, 0.64–0.79]) and fewer AUD criteria (1-level: B, −1.66 [95% CI, −2.35 to −0.98]; 2-level: B, −1.76 [95% CI, −2.31 to −1.21]) at end of treatment. Conclusions: World Health Organization risk drinking level reductions correlate with Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) AUD diagnosis and criteria, providing further evidence for their use as endpoints in alcohol intervention trials, which has potential implications for broadening the base of AUD treatment. [ABSTRACT FROM AUTHOR]

Background: Abstinence has historically been considered the preferred goal of alcohol use disorder (AUD) treatment. However, most individuals with AUD do not want to abstain and many are able to reduce their drinking successfully. Craving is often a target of pharmacological and behavioral interventions for AUD, and reductions in craving may signal recovery. Whether reductions in drinking during AUD treatment are associated with reductions in craving has not been well examined. Methods: We conducted secondary analyses of data from three AUD clinical trials (N's= 1327, 346, and 200). Drinking reductions from baseline to the end of treatment were measured as changes in World Health Organization (WHO) risk drinking levels; alcohol craving was measured using validated self‐report measures. Regression analyses tested whether drinking reductions were associated with end‐of‐treatment craving reductions; moderation analyses tested whether associations between drinking reduction and end‐of‐treatment craving differed across AUD severity. Results: Reductions of at least 1 or at least 2 WHO risk drinking levels were associated with lower craving (all p's < 0.05). Results were substantively similar after removing abstainers at the end‐of‐treatment. Associations between drinking reductions and craving were generally not moderated by AUD severity. Conclusions: Individuals with WHO risk drinking level reductions reported significantly lower craving, as compared to those who did not achieve meaningful reductions in drinking. The results demonstrate the utility of WHO risk drinking levels as AUD clinical trial endpoints and provide evidence that drinking reductions mitigate craving. [ABSTRACT FROM AUTHOR]

Background: Alcohol use disorder (AUD) is underdiagnosed and undertreated in medical settings, in part due to a lack of AUD assessment instruments that are reliable and practical for use in routine care. This study evaluates the test‐retest reliability of a patient‐report Alcohol Symptom Checklist questionnaire when it is used in routine care, including primary care and mental health specialty settings. Methods: We performed a pragmatic test‐retest reliability study using electronic health record (EHR) data from Kaiser Permanente Washington, an integrated health system in Washington state. The sample included 454 patients who reported high‐risk drinking on a behavioral health screen and completed two Alcohol Symptom Checklists 1 to 21 days apart. Subgroups of these patients who completed both checklists in primary care (n = 271) or mental health settings (n = 79) were also examined. The primary measure was an Alcohol Symptom Checklist on which patients self‐reported whether they experienced each of the 11 AUD criteria within the past year, as defined by the Diagnostic and Statistical Manual of Mental Disorders‐5th edition (DSM‐5). Results: Alcohol Symptom Checklists completed in routine care and documented in EHRs had excellent test‐retest reliability for measuring AUD criterion counts (ICC = 0.79, 95% CI: 0.76 to 0.82). Test‐retest reliability estimates were also high and not significantly different for the subsamples of patients who completed both checklists in primary care (ICC = 0.82, 95% CI: 0.77 to 0.85) or mental health settings (ICC = 0.74, 95% CI: 0.62 to 0.83). Test‐retest reliability was not moderated by having a past two‐year AUD diagnosis, nor by the age or sex of the patient completing it. Conclusions: Alcohol Symptom Checklists can reliably and pragmatically assess AUD criteria in routine care among patients who screen positive for high‐risk drinking. The Alcohol Symptom Checklist may be a valuable tool in supporting AUD‐related care and monitoring AUD criteria longitudinally in routine primary care and mental health settings. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this study was to examine associations between psychotherapy session attendance, alcohol treatment outcomes, and Alcoholics Anonymous (AA) attendance. Method: Using data from Project MATCH, repeated measures latent class analyses of psychotherapy session attendance were conducted among participants in the outpatient arm who were randomly assigned to complete 12-session cognitive-behavioral therapy (CBT; n = 301), 12-session twelve-step facilitation (TSF; n = 335), or 4-session motivational enhancement therapy (MET; n = 316). Associations between psychotherapy attendance classes, heavy drinking, alcohol-related consequences, psychosocial functioning, and AA attendance were examined at posttreatment (97% retention), 1-year posttreatment (92% retention), and 3-years posttreatment (85% retention). Results: In general, participants who attended all 12 CBT/TSF sessions had significantly fewer heavy drinking days and alcohol-related consequences at all posttreatment time points than participants who attended 0–2 CBT/TSF sessions. Participants who attended all four MET sessions generally had significantly fewer heavy drinking days and alcohol-related consequences at posttreatment and 1-year posttreatment than participants who attended 0–1 MET sessions. Participants who attended more TSF and MET sessions generally attended more AA meetings, and participants who attended less CBT sessions generally attended fewer AA meetings. Conclusions: With some exceptions, attending all sessions in CBT, TSF, and MET was related to the most favorable heavy drinking and alcohol-related consequences outcomes. Alcoholics' Anonymous and other mutual help groups may be attended differently based on the form and dose of psychotherapy What is the public health significance of this article?: Attending 12 sessions of cognitive-behavioral therapy, 12 sessions of twelve-step facilitation, and 4 sessions of motivational enhancement therapy is generally related to significant reductions in heavy drinking and alcohol-related consequences at treatment end and up to 3 years following treatment. Clinicians should talk to clients about the function of AA attendance during CBT, TSF, and MET, as well as after psychotherapy termination. [ABSTRACT FROM AUTHOR]

Objective: Four decades ago, the "controlled drinking" controversy roiled the alcohol field. Data have subsequently accumulated indicating that nonabstinent alcohol use disorder (AUD) recovery is achievable, but questions remain whether it is sustainable long-term. This study examined whether nonabstinent recovery at 3 years after AUD treatment is associated with better functioning at 10 years after treatment. Methods: Data were from the 10-year follow-up of Project MATCH (New Mexico site only, n=146; 30.1% female, 58.6% non-White). Recovery was defined by latent profile analyses based on psychosocial functioning and alcohol consumption 3 years after treatment. Drinking practices and consequences, depression, purpose in life, and anger were assessed 10 years after treatment. Distal outcome analyses examined differences in drinking and functional outcomes at 10 years as a function of the 3-year latent profiles. Analyses were preregistered at https://osf.io/3hbxr. Results: Four latent profiles identified at 3 years after treatment (ie, low functioning frequent heavy drinkers, low functioning infrequent heavy drinkers, high functioning heavy drinkers, and high functioning infrequent nonheavy drinkers) were significantly associated with outcomes 10 years after treatment. The 2 high functioning profiles at 3 years had the highest level of psychological functioning at 10 years posttreatment, regardless of alcohol consumption level. Abstinence at 3 years did not predict better psychological functioning at 10 years. Conclusions: Nonabstinent AUD recovery is possible and is sustainable for up to 10 years after treatment. The current findings align with recent proposals to move beyond relying on alcohol consumption as a central defining feature of AUD recovery. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: Clients who receive alcohol use disorder (AUD) treatment experience variable outcomes. Measuring clinical progress during treatment using standardized measures (i.e., measurement-based care) can help indicate whether clinical improvements are occurring. Measures of mechanisms of behavioral change (MOBCs) may be particularly well-suited for measurement-based care; however, measuring MOBCs would be more feasible and informative if measures were briefer and if their ability to detect reliable change with individual clients was better articulated. Method: Three abbreviated measures of hypothesized MOBCs (abstinence self-efficacy, coping strategies, anxiety) and a fourth full-length measure (depression) were administered weekly during a 12-week randomized trial of cognitive-behavioral therapy (CBT) for women with AUD. Psychometric analyses estimated how reliably each measure distinguished within-person change from between-person differences and measurement error. Reliability coefficients were estimated for simulated briefer versions of each instrument (i.e., instruments with fewer items than the already-abbreviated instruments) and rates of reliable improvement and reliable worsening were estimated for each measure. Results: All four measures had good reliability (.86–.90) for detecting within-person change. Many participants (41.4%–62.5%) reliably improved on MOBCs from first to last treatment session. Reliable improvement on MOBCs was associated with reductions in percentage of drinking days (PDD) at 3, 9, and 15-month follow-ups. Simulated briefer versions of each instrument retained good reliability for detecting change with only 3 (self-efficacy), 11 (coping strategies), 5 (anxiety), or 10 items (depression). Conclusions: Brief MOBC measures can detect reliable change for individuals in AUD treatment. Routinely measuring MOBCs may help with monitoring clinical progress. Public Health Significance: Brief measures of abstinence self-efficacy, coping strategies, depression, and anxiety reliably measure within-person clinical changes during alcohol use disorder (AUD) treatment. The 41%–63% of clients who showed reliable improvement in these measures during outpatient AUD treatment had the largest reductions in drinking days after treatment. Measuring these constructs during AUD treatment can be one way of delivering measurement-based care, an evidence-based practice that is rarely utilized in routine AUD treatment. [ABSTRACT FROM AUTHOR]

Objectives: Studying clinical course after alcohol use disorder (AUD) treatment is central to understanding longer-term recovery. This study's two main objectives were to (a) replicate a recent study that identified heterogeneity in patterns of remission from/relapse to heavy drinking during the first year after outpatient treatment in an independent data set and (b) extend these recent findings by testing associations between patterns of remission/relapse and long-term alcohol-related and functioning outcomes. Method: Latent profile analyses were conducted using data from Project MATCH (N = 952; M age = 38.9; 72.3% female) and COMBINE (N = 1,383; M age = 44.4; 69.1% male). Transitions between heavy and nonheavy drinking within consecutive 2-week periods over a 1-year posttreatment period were characterized for each participant. From this, latent profiles were identified based on participants' initial 2-week heavy drinking status, the number of observed transitions between 2-week periods of relapse and remission, and the average duration of observed remission/relapse episodes. Results: In both MATCH and COMBINE, we identified six profiles: (a) "continuous remission," 25.3% of COMBINE sample/25.3% of MATCH sample; (b) "transition to remission," 19.6%/9.6%; (c) "few long transitions," 15.9%/33.7%; (d) "many short transitions," 13.2%/13.6%; (e) "transition to relapse," 7.2%/7.1%; and (f) "continuous relapse," 18.8%/10.5%. Profiles 1 and 2 had the best long-term outcomes, Profiles 5 and 6 had the worst, and Profiles 3 and 4 fell between these groups. Conclusions: That many individuals can remit from heavy drinking following one or more relapses to heavy drinking may be of direct interest to individuals in recovery from AUD. What is the public health significance of this article?: This study indicates that a substantial portion of individuals with alcohol use disorder can indeed transition back to remission from heavy drinking following one or more relapses to heavy drinking during the first year after outpatient treatment. Furthermore, findings indicate that the ability to repeatedly regain remission from heavy drinking, even following numerous relapses to heavy drinking, may confer substantial long-term benefits to individuals who have sought treatment for alcohol use disorder. [ABSTRACT FROM AUTHOR]

Background: Recent research indicates some individuals who engage in heavy drinking following treatment for alcohol use disorder fare as well as those who abstain with respect to psychosocial functioning, employment, life satisfaction, and mental health. The current study evaluated whether these findings replicated in an independent sample and examined associations between recovery profiles and functioning up to 6 years later. Methods: Data were from the 3‐year and 7‐ to 9‐year follow‐ups of subsamples initially recruited for the COMBINE study (3‐year follow‐up: n = 694; 30.1% female, 21.0% non‐White; 7‐ to 9‐year follow‐up: n = 127; 38.9% female, 27.8% non‐White). Recovery at 3 years was defined by latent profile analyses including measures of health functioning, quality of life, employment, alcohol consumption, and cannabis and other drug use. Functioning at the 7‐ to 9‐year follow‐up was assessed using single items of self‐rated general health, hospitalizations, and alcohol consumption. Results: We identified 4 profiles at the 3‐year follow‐up: (i) low‐functioning frequent heavy drinkers (13.9%), (ii) low‐functioning infrequent heavy drinkers (15.8%), (iii) high‐functioning heavy drinkers (19.4%), and (iv) high‐functioning infrequent drinkers (50.9%). At the 7‐ to 9‐year follow‐up, the 2 high‐functioning profiles had the best self‐rated health, and the high‐functioning heavy drinking profile had significantly fewer hospitalizations than the low‐functioning frequent heavy drinking profile. Conclusions: Previous findings showing heterogeneity in recovery outcomes were replicated. Most treatment recipients functioned well for years after treatment, and a subset who achieved stable recovery engaged in heavy drinking and reported good health outcomes up to 9 years after treatment. Results question the long‐standing emphasis on drinking practices as a primary outcome, as well as abstinence as a recovery criterion in epidemiologic and treatment outcome research and among stakeholder groups and funding/regulatory agencies. Findings support an expanded recovery research agenda that considers drinking patterns, health, life satisfaction, and functioning. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Abstinence and no heavy drinking days are currently the only Food and Drug Administration–approved end points in clinical trials for alcohol use disorder (AUD). Many individuals who fail to meet these criteria may substantially reduce their drinking during treatment, and most individuals with AUD prefer drinking reduction goals. One‐ and two‐level reductions in World Health Organization (WHO) drinking risk levels have been proposed as alternative end points that reflect reduced drinking and are associated with reductions in drinking consequences, improvements in mental health, and reduced risk of developing alcohol dependence. The current study examined the association between WHO drinking risk level reductions and improvements in physical health and quality of life in a sample of individuals with alcohol dependence. Methods: Secondary data analysis of individuals with alcohol dependence (n = 1,142) enrolled in the longitudinal, prospective COMBINE study, a multi site randomized placebo‐controlled clinical trial, examining the association between reductions in WHO drinking risk levels and change in blood pressure, liver enzyme levels, and self‐reported quality of life following treatment for alcohol dependence. Results: One‐ and two‐level reductions in WHO drinking risk level during treatment were associated with significant reductions in systolic blood pressure (p < 0.001), improvements in liver enzyme levels (all p < 0.01), and significantly better quality of life (p < 0.001). Conclusions: One‐ and two‐level reductions in WHO drinking risk levels predicted significant improvements in markers of physical health and quality of life, suggesting that the WHO drinking risk level reduction could be a meaningful surrogate marker of improvements in how a person "feels and functions" following treatment for alcohol dependence. The WHO drinking risk levels could be useful in medical practice for identifying drinking reduction targets that correspond with clinically significant improvements in health and quality of life. At least 1‐ and 2‐level reductions in the World Health Organization (WHO) drinking risk levels by the end of treatment were associated with significant improvements at the end of treatment for physical health and quality of life outcomes. The WHO drinking risk level reductions capture considerable improvement in how patients feel and function in alcohol clinical trials. [ABSTRACT FROM AUTHOR]

Background: We sought to understand alcohol behavior change as a process over time by identifying patterns of relapse and remission after outpatient treatment and evaluating how these patterns predict longer-term clinical outcomes.Method: We conducted latent profile analyses using data from the outpatient arm in Project MATCH. Relapse and remission episodes were defined by the number of consecutive 14-day periods that included any heavy drinking days and no heavy drinking days. Indicators of each profile were: initial 2-week post-treatment remission/relapse status, number of remission/relapse transitions in the first year after treatment, duration of remission episodes, and duration of relapse episodes.Results: We identified 6 profiles: 1) "remission," 2) "transition to remission", 3) "few long transitions," 4) "many short transitions," 5) "transition to relapse," and 6) "relapse." Profile 1 had the best long-term outcomes. Long-term outcomes were not uniform among individuals with at least some heavy drinking (profiles 2 through 6; ∼75% of the sample). Individuals who transitioned back to and sustained periods of remission (profiles 2-4) had better long-term outcomes than those who failed to transition out of relapse (profiles 5-6) following treatment.Conclusions: Post-treatment change in alcohol use is a process in which individuals variably transition in and out of "relapse" and "remission" statuses. "Any heavy drinking" following treatment is not necessarily a sign of treatment failure. A more nuanced look at the process of AUD change by considering whether individuals are able to transition to and sustain periods of remission seems warranted. [ABSTRACT FROM AUTHOR]

Background Recently, the Food and Drug Administration ( FDA) proposed to expand the options for primary end points in the development of medications for alcohol use disorder to include either abstinence from alcohol or a nonabstinent outcome: no heavy drinking days (with a heavy drinking day defined as more than 3 drinks per day for women and more than 4 drinks per day for men [>3/>4 cutoff]). The FDA also suggested that 6 months would be the most appropriate length for a clinical trial to demonstrate the stability of this nonabstinent drinking outcome. However, few alcohol clinical trials have examined the stability of nonheavy drinking during and after treatment. Methods In a secondary analysis of the COMBINE study data ( n = 1,383), we examined transitions in heavy drinking days during the course of treatment (months 1 through 4), during the transition out of treatment (months 4 through 7), and up to 12 months afterward (months 13 through 16) using latent variable mixture models. Results Heavy drinking and nonheavy drinking were relatively stable in consecutive months (minimum agreement [kappa] = 0.64 for months 1 to 2). Most individuals were stable low-risk drinkers/abstainers or heavy drinkers by the end of treatment, as characterized by a 10% probability (or less) of transitioning out of either a no heavy drinking state or a heavy drinking state. More than two-thirds of the heavy drinkers who exceeded the heavy drinking threshold during treatment reported, on average, a 64% reduction in drinking frequency and a 38% reduction in drinking intensity from pretreatment drinking levels. Conclusions The results show stability of no heavy drinking as an outcome within the first 4 months of treatment and that the >3/>4 drink cutoff may mask substantial reductions in alcohol consumption among some patients. Future studies should explore the clinical utility of reduction end points. [ABSTRACT FROM AUTHOR]

Background The construct of relapse is used widely in clinical research and practice of alcohol use disorder (AUD) treatment. The purpose of this study was to test the predictive validity of commonly appearing definitions of AUD relapse in the empirical literature. Methods Secondary analyses of data from Project MATCH and COMBINE were conducted using 7 definitions of 'relapse' based on drinking quantity within a single drinking episode: any drinking; at least 4/5 drinks for women/men; at least 4.3/7.1 drinks for women/men; at least 6/7 drinks for women/men; at least 6 drinks; at least 7/9 drinks for women/men; and at least 8/10 drinks for women/men. Relapse was used to predict alcohol consumption, related consequences, and nonconsumption outcomes (quality of life, psychosocial functioning) at the end of treatment and up to 1 year posttreatment. Results Regression analyses indicated within-treatment relapse definitions significantly predicted end-of-treatment alcohol consumption and alcohol-related consequences. Heavy drinking definitions were generally more predictive than the any drinking definition, but no single heavy drinking definition was consistently a better predictor of outcomes. Relapse definitions were less predictive of longer-term alcohol-related outcomes and both shorter- and longer-term nonconsumption outcomes, including health and psychosocial functioning. Conclusions One particular definition of relapse did not consistently stand out as the best predictor. Advances in AUD research may require reconceptualization of relapse as a multifaceted dynamic process and may consider a wider range of relevant behaviors (e.g., health and psychosocial functioning) when examining the change process in individuals with AUD. [ABSTRACT FROM AUTHOR]

Background: The validity of the alcohol dependence syndrome has been supported. The question of whether different measures of the construct are comparable across studies and patient subgroups has not been examined. This study examined the alcohol dependence construct across four diverse large-scale treatment samples using integrative data analysis (IDA).Method: We utilized existing data (n=4393) from the COMBINE Study, Project MATCH, the Relapse Replication and Extension Project (RREP), and the United Kingdom Alcohol Treatment Trial (UKATT). We focused on four measures of alcohol dependence: the Alcohol Dependence Scale (COMBINE and RREP), Alcohol Use Inventory (MATCH), the Leeds Dependence Questionnaire (UKATT), and the Diagnostic and Statistical Manual of Mental Disorders (COMBINE and MATCH). Moderated nonlinear factor analysis was used to create a measure of alcohol dependence severity that was moderated by study membership, gender, age, and marital status.Results: A commensurate measure of alcohol dependence severity was successfully created using 20 items available in four studies. We identified differential item functioning by study membership, age, gender, and/or marital status for 12 of the 20 items, indicating specific patient subgroups who responded differently to items based on their underlying dependence severity.Conclusions: Alcohol dependence severity is a single unidimensional construct that is comparable across studies. The use of IDA provided a strong test of the validity of the alcohol dependence syndrome and clues as to how some items used to measure dependence severity may be more or less central to the construct for some patients. [ABSTRACT FROM AUTHOR]

Background Attrition is common in alcohol clinical trials and the resultant loss of data represents an important methodological problem. In the absence of a simulation study, the drinking outcomes among those who are lost to follow-up are not known. Individuals who drop out of treatment and continue to provide drinking data, however, may be a reasonable proxy group for making inferences about the drinking outcomes of those lost to follow-up. Methods We used data from the COMBINE study, a multisite, randomized clinical trial, to examine drinking during the 4 months of treatment among individuals who dropped out of treatment but continued to provide drinking data (i.e., 'treatment dropouts;' n = 185). First, we estimated the observed treatment effect size for naltrexone versus placebo in a sample that included both treatment completers ( n = 961) and treatment dropouts ( n = 185; total N = 1,146), as well as the observed treatment effect size among just those who dropped out of treatment ( n = 185). In both the total sample ( N = 1,146) and the dropout sample ( n = 185), we then deleted the drinking data after treatment dropout from those 185 individuals to simulate missing data. Using the deleted data sets, we then estimated the effect of naltrexone on the continuous outcome percent heavy drinking days using 6 methods to handle missing data (last observation carried forward, baseline observation carried forward, placebo mean imputation, missing = heavy drinking days, multiple imputation ( MI), and full information maximum likelihood [ FIML]). Results MI and FIML produced effect size estimates that were most similar to the true effects observed in the full data set in all analyses, while missing = heavy drinking days performed the worst. Conclusions Although missing drinking data should be avoided whenever possible, MI and FIML yield the best estimates of the treatment effect for a continuous outcome measure of heavy drinking when there is dropout in an alcohol clinical trial. [ABSTRACT FROM AUTHOR]

Background The rate of participant attrition in alcohol clinical trials is often substantial and can cause significant issues with regard to the handling of missing data in statistical analyses of treatment effects. It is common for researchers to assume that missing data is indicative of participant relapse, and under that assumption, many researchers have relied on setting all missing values to the worst-case scenario for the outcome (e.g., missing = heavy drinking). This sort of single-imputation method has been criticized for producing biased results in other areas of clinical research, but has not been evaluated within the context of alcohol clinical trials, and many alcohol researchers continue to use the missing = heavy drinking assumption. Methods Data from the COMBINE study, a multisite randomized clinical trial, were used to generate simulated situations of missing data under a variety of conditions and assumptions. We manipulated the sample size ( n = 200, 500, and 1,000) and dropout rate (5, 10, 25, 30%) under 3 missing data assumptions (missing completely at random, missing at random, and missing not at random). We then examined the association between receiving naltrexone and heavy drinking during the first 10 weeks following treatment using 5 methods for treating missing data (complete case analysis [CCA], last observation carried forward [LOCF], missing = heavy drinking, multiple imputation [MI], and full information maximum likelihood [FIML]). Results CCA, LOCF, and missing = heavy drinking produced the most biased naltrexone effect estimates and standard errors under conditions that are likely to exist in randomized clinical trials. MI and FIML produced the least biased naltrexone effect estimates and standard errors. Conclusions Assuming that missing = heavy drinking produces biased results of the treatment effect and should not be used to evaluate treatment effects in alcohol clinical trials. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this study was to examine whether changes in heavy drinking occurring within alcohol treatment predict long-term functioning.Method: Latent profile analyses were conducted using data from Project MATCH and COMBINE. Observed changes in heavy and nonheavy drinking within consecutive 2-week periods over the respective treatment durations were characterized for each participant and were used to identify latent profiles.Results: Both data sets revealed 6 profiles: (1) continuous "remission" (nonheavy drinking); (2) transition from heavy drinking ("relapse") to remission; (3) mostly remission, limited relapse; (4) numerous short transitions between relapse and remission; (5) transition to relapse; and (6) continuous relapse. Profiles 1 and 2 had the best long-term outcomes, Profiles 5 and 6 had the worst, and Profiles 3 and 4 fell between these groups. Within-treatment patterns of heavy drinking and nonheavy drinking were also associated with post-treatment patterns of relapse and remission.Conclusions: Patterns of transition between episodes that respectively include heavy and nonheavy drinking predict long-term alcohol use and psychosocial outcomes and seem essential for clinicians to discuss with their patients. Relapses during outpatient treatment do not necessarily indicate treatment failure, provided they are relatively brief and/or infrequent. In addition, some individuals can and do change from transition patterns of heavy drinking within treatment that are predictive of poorer long-term functioning to transition patterns that predict better functioning within the first year post-treatment. [ABSTRACT FROM AUTHOR]

Objectives: To test group-based Female-Specific Cognitive Behavioral Therapy (G-FS-CBT) for women with Alcohol Use Disorder (AUD) against an individual Female-Specific Cognitive Behavioral Therapy (I-FS-CBT). This aims of this paper are to describe G-FS-CBT development, content, feasibility, acceptability, group process, engagement in treatment, and within- and post-treatment outcomes.Methods: Women with AUD (n=155) were randomly assigned to 12 manual-guided sessions of G-FS-CBT or I-FS-CBT; 138 women attended at least one treatment session.Results: Women in G-FS-CBT attended fewer sessions (M=7.6) than women in I-FS-CBT (M=9.7; p<.001). Women in both conditions reported high satisfaction with the treatments. Independent coders rated high fidelity of delivery of both G-FS-CBT and I-FS-CBT. Therapeutic alliance with the therapist was high in both conditions, with I-FS-CBT being slightly but significantly higher than G-FS-CBT. In the first six weeks of treatment, women in both treatment conditions significantly reduced their percent drinking days (PDD) and percent heavy days drinking (PHD) by equivalent amounts, maintained through the rest of treatment and the 12month follow up with no treatment condition effects. Women reported significant improvement in all but one of the secondary outcomes during treatment; gains made during treatment in depression, anxiety, autonomy, and interpersonal problems were maintained during the follow-up period, while gains made during treatment in use of coping skills, self-efficacy for abstinence, self-care, and sociotropy deteriorated over follow up but remained improved compared to baseline.Conclusions: Findings support the feasibility, acceptability, and efficacy of a group format for female-specific CBT for AUD, a new 12-session, single gender, community friendly, group therapy with programming specifically for women. Similar, positive outcomes for individual and group treatment formats were found for drinking, mood, coping skills, self-confidence, interpersonal functioning, and self-care. [ABSTRACT FROM AUTHOR]

Background: Self-report measures of alcohol problems are commonly included in studies evaluating treatment and recovery from alcohol use disorder (AUD), but no prior study has examined the replicability of the measurement of alcohol problems across studies with various measures and diverse samples. Further, it is unclear which items may be better indicators of alcohol problems for patient subgroups. In the present study, we integrated data from four large alcohol treatment studies to develop a commensurate measure of alcohol problems using moderated nonlinear factor analysis (MNLFA).Methods: Data were from the COMBINE study, Project MATCH, the Relapse Replication and Extension Project (RREP), and the United Kingdom Alcohol Treatment Trial (UKATT), yielding a total sample size of 4414. MNLFA was carried out on the Drinker Inventory of Consequences (COMBINE, MATCH, RREP) and Alcohol Problems Questionnaire (UKATT).Results: We successfully created a 78-item commensurate measure of alcohol problems and examined differential item functioning (DIF) by study membership, time, and socio-demographic characteristics. Sixty-two items demonstrated intercept DIF, suggesting differences in rates of item endorsement for clients with the same underlying levels of alcohol problems across patient subgroups. Six items demonstrated loading DIF, suggesting differences in the extent to which the items were indicative of alcohol problems across patient subgroups.Conclusions: The self-reported measurement of alcohol problems replicates across measures and diverse samples. Items with DIF have clinical implications for the treatment of AUD. Finally, MNLFA scores can be used to test substantive research questions across these studies. [ABSTRACT FROM AUTHOR]

Screening for unhealthy alcohol use in primary care may help identify patients at risk for negative health outcomes. This study examined the associations between 1) screening with the AUDIT-C (alcohol consumption) and 2) an Alcohol Symptom Checklist (symptoms of alcohol use disorder) and subsequent-year hospitalizations. This retrospective cohort study was conducted in 29 primary care clinics in Washington State. Patients were screened in routine care (10/1/2016–2/1/2019) with the AUDIT-C (0−12) and administered the Alcohol Symptom Checklist (0−11) if they had AUDIT-C score ≥ 7. All-cause hospitalizations were measured within 1 year of the AUDIT-C and Alcohol Symptom Checklist. AUDIT-C and Alcohol Symptom Checklist scores were categorized based on previously used cut-points. Of 305,376 patients with AUDIT-Cs, 5.3% of patients were hospitalized in the following year. AUDIT-C scores had a J-shaped relationship with hospitalizations, with risk for all-cause hospitalizations higher for patients with the AUDIT-C scores 9–12 (12.1%; 95% CI: 10.6–13.7%, relative to a comparison group of those with AUDIT-C scores 1–2 (female)/1–3 (male) (3.7%; 95% CI: 3.6–3.8%), adjusted for socio-demographics. Patients with AUDIT-C ≥ 7 and Alcohol Symptom Checklist scores reflecting severe AUD were at increased risk of hospitalization (14.6%, 95% CI: 11.9–17.9%) relative to those with lower scores. Higher AUDIT-C scores were associated with higher incidence of hospitalizations except among people with low-level drinking. Among patients with AUDIT-C ≥ 7, the Alcohol Symptom Checklist identified patients at increased risk of hospitalization. This study helps demonstrate the potential clinical utility of the AUDIT-C and Alcohol Symptom Checklist. • Unhealthy alcohol use increases risk for negative health outcomes. • Brief screening tools can be used to identify unhealthy alcohol use in primary care • Unhealthy alcohol use is associated with greater risk of future hospitalization [ABSTRACT FROM AUTHOR]