Substance use-related continuing education course objectives: Alignment with professional competencies.

Background: Novel educational efforts are needed to prepare the current and future interprofessional health care workforce to address the range of substance use-related health problems. A 6-module massive open online course (MOOC) was developed to provide education to health professionals of various disciplines on the fundamentals of substance use-related treatment. The purpose of this project was to match course objectives to substance use-related competencies for 5 disciplines: nurses, pharmacists, physicians, physician assistants (PA), and social workers. Methods: Content expert raters within each discipline determined what Association for Multidisciplinary Education and Research in Substance use and Addiction (AMERSA) core competencies were matched to each objective for the 6 modules of the MOOC. The number of objectives across the 6 modules was summated. Results: All nursing and social work competencies were mapped to the course objectives. For physicians, PAs, and pharmacists, the proportions of knowledge-based competencies that mapped to the course objective were 58%, 76%, and 80%, respectively, and proportions of skill-based competencies that mapped to the course objective were 88%, 83%, and 75%, respectively. For those 3 groups, 100% of attitude-based competencies mapped to the course objective. Conclusions: The competency-based mapping with the MOOC objectives supports the interprofessional design of the course and discipline-specific competencies needed to promote the best outcomes for patients.

Longitudinal Findings from a Randomized Clinical Trial of Varenicline for Alcohol Use Disorder with Comorbid Cigarette Smoking.

BACKGROUND: This study is the first to examine longitudinal posttreatment outcomes of a placebo-controlled trial of varenicline for alcohol use disorder (AUD) with comorbid cigarette smoking. METHODS: Participants were 131 adults (n = 39 female) seeking alcohol treatment in a randomized, double-blind, parallel group, placebo-controlled, 16-week multisite trial of varenicline combined with medical management (MM). Timeline follow-back assessments of alcohol and smoking behavior were conducted at the end of treatment (4 months), with follow-ups at 6, 9, and 12 months. Outcomes were percentage of heavy drinking days (PHDD), percent of participants with no heavy drinking days (NHDD), cotinine-confirmed prolonged smoking abstinence (PA), and good clinical outcome on either NHDD or PA. RESULTS: Treatment improvements were maintained posttreatment. For the sample overall, PHDD or NHDD did not differ significantly by treatment condition (ps > 0.13), but varenicline produced higher rates of PA versus placebo at 4, 9, and 12 months (p < 0.05). Significant differences were observed by sex: Males had higher rates of NHDD with varenicline (28.9%) versus placebo (6.4%) at the end of treatment (p = 0.004), and these effects were maintained at 12 months (varenicline: 40.0% vs. placebo: 19.2%, p = 0.03). Higher rates of PA were seen for varenicline in both males (8.9%) and females (21.1%) versus placebo (males/females: 0%) at the end of treatment (p = 0.05), and this effect was maintained at 12 months for females (varenicline: 21.1% vs. placebo, 0.0%, p = 0.05). CONCLUSIONS: Varenicline treatment combined with MM appears to have enduring benefits for patients with co-occurring AUD and cigarette smoking, and these effects may differ by sex.

Commentary on the adding individual psychotherapy after relapse in a pharmacotherapy trial: commentary on the PREDICT study.

BACKGROUND: With few exceptions there has been a dearth of research evaluating the independent and combined effects of a promising medication and an effective behavioral intervention for alcohol problems. Few studies have incorporated both theory and empirical findings to ascertain how the combination of medication and behavioral intervention interact or work synergistically to produce better outcomes or why a particular combination of pharmacological and behavioral treatment works better than another combination or either of the interventions employed alone. METHODS: The PREDICT Study is one of the few pharmacotherapy trials that has utilized a behavioral intervention to reduce/delay relapse to heavy drinking. The findings in the PREDICT Study were reviewed to gain a better understanding of how the combination of pharmacotherapy and behavioral intervention can be employed to manage the course of recovery for individuals with alcohol use disorders (AUDs). RESULTS: Findings in the PREDICT Study show that behavioral interventions and pharmacotherapies have complementary functions that can be utilized to address the differential needs, capabilities, and resources associated with AUDs. However, researchers were forced to rely mainly on their own clinical experiences rather than an overarching conceptual model in determining how the approach should be employed with AUD patients, thereby limiting the conclusions that could be drawn from the study findings. CONCLUSIONS: Different vulnerabilities underlying AUDs should be considered in determining what kinds of behavioral interventions should be paired with particular medications. At the same time, we need to have a better understanding of the clinical course of pharmacobehavioral treatment to deal with the array of problems/situations that arise over the course of combination therapy.

Does session attendance by a supportive significant other predict outcomes in individual treatment for alcohol use disorders?

BACKGROUND: A significant amount of research has supported the efficacy of couple versus individual treatment for alcohol use disorders, yet little is known about whether involving a significant other during the course of individual treatment can improve outcomes. Likewise, several barriers to couple treatment exist and a more flexible approach to significant other involvement may be warranted. METHODS: This study constituted secondary analyses of the COMBINE data, a randomized clinical trial that combined pharmacotherapy and behavioral intervention for alcohol dependence. Data were drawn from the 16-week individual combined behavioral intervention (CBI), which had 776 participants, 31% of which were female, and 23% were non-white. The current study examined whether attendance by a supportive significant other (SSO) during CBI sessions would predict better outcomes. It was further hypothesized that active SSO involvement, defined by attendance during drink refusal or communication skills training sessions, would predict better outcomes. RESULTS: SSOs attended at least 1 session for 26.9% of clients. Clients with SSOs who attended at least 1 session had significantly fewer drinking days and fewer drinking-related problems at the end of treatment. The presence of an SSO during a drink refusal training session predicted significantly better outcomes, as compared to SSO attendance at other sessions and drink refusal training without an SSO present. SSO attendance at a communication training session did not predict better outcomes. CONCLUSIONS: These results suggest that specific types of active involvement may be important for SSO-involved treatment to have greater efficacy than individual treatment.

The effect of varenicline on smoking and drinking outcomes among Black and White adults with alcohol use disorder and co-occurring cigarette smoking: A secondary analysis of two clinical trials.

INTRODUCTION: Varenicline is an FDA-approved medication for smoking cessation and has demonstrated promise in reducing alcohol use. This study sought to compare the efficacy of varenicline in reducing smoking and drinking among Black and White people seeking alcohol treatment. METHODS: Linear mixed modeling was conducted using data from two multi-site placebo-controlled randomized clinical trials examining the effects of varenicline for treatment of Alcohol Use Disorder (AUD; O'Malley et al., 2018; Litten et al., 2013) among Black and White adults with AUD and co-occurring cigarette smoking. The primary analyses were conducted in a sample of 117 adults (O'Malley trial: 29.1% female, 55.2% Black), and replicated in an independent sample of 73 adults (Litten trial: 23.3% female, 45.2% Black). RESULTS: Black participants smoked fewer cigarettes per day compared to White participants (O'Malley trial: F1,116 = 8.95, p = .003; Litten trial: F1,68.9 = 4.74p = .03). Linear mixed models revealed a marginal effect of varenicline on reducing cigarettes smoked per day regardless of race in the O'Malley trial (F1,109 = 3.34, p = .07), which was replicated in the Litten trial (F1,67.1 = 20.77p < .0001). Participants reduced the number of drinks consumed regardless of treatment condition or race in both trials (O'Malley trial: F1,98 = 131.69, p < .0001; Litten trial:F1,69 = 60.36, p < .0001). CONCLUSIONS: Our adjusted model findings suggest varenicline reduced smoking among Black and White people with AUD and co-occurring cigarette smoking. However, these findings should be replicated in a larger sample.

PTSD / substance use disorder comorbidity: Treatment options and public health needs.

Purpose of Review: Posttraumatic stress disorder (PTSD) commonly co-occurs with substance use disorder (SUD) and is challenging to treat. We review all behavioral therapy models with at least one randomized controlled trial in a current PTSD/SUD population. We identify factors in selecting a model for clinical use, emphasizing a public health framework that balances the need for evidence with the need for feasibility in frontline settings. Recent Findings: Seven published models and 6 unpublished models are reviewed. Public health considerations for choosing a model include: whether it's been studied across a broad range of SUDs and in complex SUD patients; whether it can be conducted in group modality; its appeal to patients and providers; its cost; workforce requirements; and its ability to reduce substance use in addition to PTSD. Summary: There are two broad types of models: those that originated in the PTSD field versus the SUD field. Overall, the latter are stronger on public health factors and more feasible in SUD settings. Published models in this category include Relapse Prevention, BRENDA, and Seeking Safety. PTSD/SUD research is at an early stage and there is a need for methodology that quantifies "level of burden" (patients' socioeconomic disadvantages) across trials.

Effective Strategies for Maintaining Research Participation in Clinical Trials.

Achieving high protocol adherence is essential for ensuring the overall success and scientific merit of clinical trials. Strategies for maximizing recruitment and treatment adherence have been previously explored in the literature. There has been less focus, however, on effective methods for maintaining participants in research follow-up. This article examines factors associated with poor follow-up rates as well as strategies for facilitating research commitment and addressing sources of nonadherence. Special attention is devoted to alcohol- and substance-dependent populations, groups known to have poor adherence rates. Examples are drawn from the COMBINE Study, an NIAAA-funded, nationwide, multisite, combined behavioral and pharmacotherapy trial for alcohol problems that achieved high one-year follow-up rates. The important role of coordinating centers in facilitating research retention is also discussed.

Relationship between medication adherence and treatment outcomes: the COMBINE study.

BACKGROUND: Within the alcoholism field, there is mounting evidence supporting an important relationship between medication adherence and drinking outcomes. Little is known however, about the complex relationships between medication and treatment variables and drinking outcomes. The present paper reports on the differential impact of medication adherence and treatment factors on drinking outcomes. Data derived from the COMBINE Study was used to investigate the interrelationships between medication adherence, combination treatments and drinking outcomes. METHODS: Twelve hundred and twenty-six patients were randomized to 1 of 8 different combination treatments involving 2 medications--naltrexone and acamprosate and placebo, and 2 behavioral treatments--medical management (MM) and combined behavioral intervention (CBI). Two primary drinking outcomes were percent days abstinent (PDA) and time to first heavy drinking day. Medication adherence was defined as a proportion that reflects the number of pills taken by the maximum number of pills expected to be taken over the course of the trial. A generalized linear mixed model was used to estimate the effects of adherence on PDA while proportional hazards model was used to examine similar co-variate effects on time to first heavy drinking day. RESULTS: Concerning time to first heavy drinking day, a significant three-way interaction was found between medication adherence, CBI and naltrexone (p = 0.0160). Within the MM only plus placebo group (no CBI), significant differences were found in "recovery" (i.e., no heavy drinking days) rates between adherers and nonadherers (40% vs. 10%, p < 0.0001). Such differences became nonsignificant (p = 0.12) when CBI was introduced into the relationship. CBI did not add any such advantage to naltrexone-treated patients. CONCLUSIONS: CBI might serve a protective function for nonadherers in the placebo group; the median relapse time was reduced when these nonadherers were exposed to the alcohol specialty intervention. CBI offered little additional benefit to nonadherers in the naltrexone group. Among nonadherers in the naltrexone group, relapse rates appear to be more a function of inadequate exposure to the active medication and less influenced by CBI.

Effect of Varenicline Combined With Medical Management on Alcohol Use Disorder With Comorbid Cigarette Smoking: A Randomized Clinical Trial.

Importance: Individuals with alcohol use disorder have high rates of cigarette smoking. Varenicline tartrate, an approved treatment for smoking cessation, may reduce both drinking and smoking. Objectives: To test the efficacy of varenicline with medical management for patients with alcohol use disorder and comorbid smoking seeking alcohol treatment, and to evaluate the secondary effects on smoking abstinence. Design, Setting, and Participants: This phase 2, randomized, double-blind, parallel group, placebo-controlled trial was conducted at 2 outpatient clinics from September 19, 2012, to August 31, 2015. Eligible participants met alcohol-dependence criteria and reported heavy drinking (≥5 drinks for men and ≥4 drinks for women) 2 or more times per week and smoking 2 or more times per week; 131 participants were randomized to either varenicline or placebo stratified by sex and site. All analyses were of the intention-to-treat type. Data analysis was conducted from February 5, 2016, to September 29, 2017. Interventions: Varenicline tartrate, 1 mg twice daily, and matching placebo pills for 16 weeks. Medical management emphasized medication adherence for 4 weeks followed by support for changing drinking. Main Outcomes and Measures: Percentage of heavy drinking days (PHDD) weeks 9 to 16, no heavy drinking days (NHDD) weeks 9 to 16, and prolonged smoking abstinence weeks 13 to 16. Results: Of 131 participants, 39 (29.8%) were women and 92 (70.2%) were men, the mean (SD) age was 42.7 (11.7) years, and the race/ethnicity self-identified by most respondents was black (69 [52.7%]). Sixty-four participants were randomized to receive varenicline, and 67 to receive placebo. Mean change in PHDD between varenicline and placebo across sex and site was not significantly different. However, a significant treatment by sex by time interaction for PHDD (F1,106 = 4.66; P = .03) revealed that varenicline compared with placebo resulted in a larger decrease in log-transformed PHDD in men (least square [LS] mean difference in change from baseline, 0.54; 95% CI, -0.09 to 1.18; P = .09; Cohen d = 0.45) but a smaller decrease in women (LS mean difference, -0.69; 95% CI, -1.63 to 0.25; P = .15; Cohen d = -0.53). Thirteen of 45 men (29%) had NHDD taking varenicline compared with 3 of 47 men (6%) taking placebo (Cohen h = 0.64; 95% CI, 0.22-1.03), whereas 1 of 19 women (5%) had NHDD compared with 5 of 20 women (25%) taking placebo (Cohen h = -0.60; 95% CI, -1.21 to 0.04). Taking varenicline, 8 of 64 participants (13%) achieved prolonged smoking abstinence; no one (0 of 67) quit smoking taking placebo (P = .003; Cohen h = 0.72; 95% CI, 0.38-1.07). Conclusions and Relevance: Varenicline with medical management resulted in decreased heavy drinking among men and increased smoking abstinence in the overall sample. Varenicline could be considered to promote improvements in men with these dual behavioral health risks. Trial Registration: clinicaltrials.gov Identifier: NCT01553136.

Combined pharmacotherapies and behavioral interventions for alcohol dependence: the COMBINE study: a randomized controlled trial.

CONTEXT: Alcohol dependence treatment may include medications, behavioral therapies, or both. It is unknown how combining these treatments may impact their effectiveness, especially in the context of primary care and other nonspecialty settings. OBJECTIVES: To evaluate the efficacy of medication, behavioral therapies, and their combinations for treatment of alcohol dependence and to evaluate placebo effect on overall outcome. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial conducted January 2001-January 2004 among 1383 recently alcohol-abstinent volunteers (median age, 44 years) from 11 US academic sites with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnoses of primary alcohol dependence. INTERVENTIONS: Eight groups of patients received medical management with 16 weeks of naltrexone (100 mg/d) or acamprosate (3 g/d), both, and/or both placebos, with or without a combined behavioral intervention (CBI). A ninth group received CBI only (no pills). Patients were also evaluated for up to 1 year after treatment. MAIN OUTCOME MEASURES: Percent days abstinent from alcohol and time to first heavy drinking day. RESULTS: All groups showed substantial reduction in drinking. During treatment, patients receiving naltrexone plus medical management (n = 302), CBI plus medical management and placebos (n = 305), or both naltrexone and CBI plus medical management (n = 309) had higher percent days abstinent (80.6, 79.2, and 77.1, respectively) than the 75.1 in those receiving placebos and medical management only (n = 305), a significant naltrexone x behavioral intervention interaction (P = .009). Naltrexone also reduced risk of a heavy drinking day (hazard ratio, 0.72; 97.5% CI, 0.53-0.98; P = .02) over time, most evident in those receiving medical management but not CBI. Acamprosate showed no significant effect on drinking vs placebo, either by itself or with any combination of naltrexone, CBI, or both. During treatment, those receiving CBI without pills or medical management (n = 157) had lower percent days abstinent (66.6) than those receiving placebo plus medical management alone (n = 153) or placebo plus medical management and CBI (n = 156) (73.8 and 79.8, respectively; P<.001). One year after treatment, these between-group effects were similar but no longer significant. CONCLUSIONS: Patients receiving medical management with naltrexone, CBI, or both fared better on drinking outcomes, whereas acamprosate showed no evidence of efficacy, with or without CBI. No combination produced better efficacy than naltrexone or CBI alone in the presence of medical management. Placebo pills and meeting with a health care professional had a positive effect above that of CBI during treatment. Naltrexone with medical management could be delivered in health care settings, thus serving alcohol-dependent patients who might otherwise not receive treatment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00006206.

Recruiting and retaining participants in a combined behavioral and pharmacological clinical trial.

OBJECTIVE: This article focuses on the practical and methodological considerations that went into recruiting and retaining participants in a complex clinical trial. It describes multiple recruitment strategies that were employed to meet stringent eligibility criteria and manage efficiently the flow of participants to fulfill recruitment goals. Both study-wide and site-specific methods that were employed to maximize retention rates are discussed. Also discussed is how the coordinating center worked together with study investigators to improve recruitment and retention. METHOD: A multidimensional perspective on recruitment and retention is discussed. Details are provided on how barriers to recruitment and retention were addressed. Intervention strategies designed by the coordinating center to meet performance goals are described. Data are presented to support the utility of recruitment and retention methods. The COMBINE Study served as a case illustration for various issues addressed in the article. RESULTS: As a result of the combined efforts of the coordinating center and study sites, there was steady improvement in recruitment and retention rates over the course of the trial. The recruitment goal of 1,375 participants was surpassed by September 2003. Also, improvement in data completeness rates improved by 18-27 percentage points over a 3-year period, culminating in follow-up rates meeting or exceeding performance goals by 2004. CONCLUSIONS: Various strategies and procedures designed to address recruitment and retention problems in large, complex combination pharmacotherapy and behavioral trials were effective in meeting recruitment and retention goals. The lessons learned may be of value to investigators not only involved in multisite, combination trials but in monotherapy and/or single-site studies as well.

Origins, issues and options in the development of the combined behavioral intervention.

OBJECTIVE: The aim of the investigators was to develop a moderate intensity comprehensive behavioral treatment based on the principles of motivational interviewing and Cognitive Behavioral Therapy that, within the confines of a standardized abstinence-oriented treatment, would provide a broad spectrum of modules to assist those seeking treatment to achieve reduction of problematic drinking. METHOD: The core issue of how to deliver a flexible therapy tailored to the needs of individual clients while at the same time providing a standardized treatment protocol for a randomized clinical trial provided the dilemma out of which this unique standardized protocol arose. By using a single decision tree, client choice, combined with limited options, we were able to reconcile these conflicting demands. RESULTS: Key decisions that were made in developing the treatment protocol and the thinking leading to these decisions are described. CONCLUSIONS: Understanding these key issues and the factors that led to the decisions made will assist would-be users in their own clinical and/or clinical research needs.

When worlds collide: blending the divergent traditions of pharmacotherapy and-psychotherapy outcome research.

OBJECTIVE: The multisite COMBINE Study brought together a team of alcoholism investigators who varied in whether their expertise was primarily in pharmacotherapy research or in studying psychotherapy. The process of designing a single trial that tested combinations of psychotherapy and pharmacotherapy highlighted the differences in these two research traditions and necessitated a number of compromises that are the focus of this article. METHOD: The COMBINE trial was designed to investigate the efficacy, separately and in combination, of two medications (i.e., naltrexone, acamprosate) with Medical Management and a state-of-the-art psychotherapy, known as the Combined Behavioral Intervention. RESULTS: Pharmacotherapy researchers favored studying outcome during the treatment period when medications were administered, viewing behavioral intervention as a means for minimizing variance during treatment and providing ethical care in placebo-controlled studies. In contrast, psychotherapy researchers focused on assessment of outcomes after treatment, regarding the behavioral intervention as a source of long-lasting change, necessitating careful training and monitoring of its implementation. The two traditions also differed on variables of interest in studying treatment process and secondary outcomes and methods of data collection and analysis. Some of the solutions reached by the COMBINE Study Research Group included studying both the short-term and long-term effects of treatment and selective inclusion of measures designed to evaluate processes specific to medications and to behavioral interventions. CONCLUSIONS: The successful compromises reached by the COMBINE Study Research Group may be helpful to other transdisciplinary research teams undertaking a combined evaluation of promising medications and behavioral interventions for alcoholism.

Quality of life as an outcome measure in alcoholism treatment research.

OBJECTIVE: The present article reviews the literature to date dealing with quality of life (QoL) as it relates to drinking behavior, alcohol use disorders and treatment outcome. METHOD: Articles using the term "quality of life" to describe a status or outcome construct for individuals diagnosed with or being treated for alcohol use disorders or that used one or more instruments considered to reflect patients' QoL were identified primarily through Psychological Abstracts, MEDLINE and the National Institute on Alcohol Abuse and Alcoholism's ETOH archival database. RESULTS: Thirty-six studies, published between 1993 and 2004, met these criteria. Twelve different QoL measures were used. Frequent heavy drinking or episodic heavy drinking (e.g., five or more drinks per occasion) patterns were associated with reduced QoL. Alcoholics had lower levels of QoL compared with general population norms or with other chronic health conditions. This relationship appears to be moderated by a number of sociodemographic and client characteristics, such as age, education, gender and co-occurring psychiatric disorders. Alcohol-dependent individuals experience improvements in QoL across treatment and with both short-term and long-term abstinence. Despite these improvements, many alcoholic individuals' QoL is unlikely to equal or exceed that of normative groups. Also, among hazardous and harmful drinkers, achieving and maintaining a marked reduction in drinking, even without complete abstinence, is associated with significant increases in QoL. CONCLUSIONS: QoL represents an important area to consider in assessing individuals with alcohol use disorders and in evaluating alcoholism treatment outcome.

Use of a "psychotherapy with no pills" treatment condition as part of a combined pharmacotherapy-psychotherapy research study of alcohol dependence.

OBJECTIVE: The purpose of this article is to review issues related to the use of placebo medication in a study examining combined pharmacotherapy and psychotherapy for alcohol dependence. METHOD: Little is known about the strength of the placebo effect in alcohol-dependent patients. One way to study this is to compare placebo to no pharmacological treatment. The multisite National Institute on Alcohol Abuse and Alcoholism COMBINE Study is examining optimal combinations of two medications (acamprosate and naltrexone) and two behavioral treatments (a moderate-intensity treatment called Combined Behavioral Intervention [CBI] and a low-intensity treatment called Medical Management [MM]) for alcohol-dependent patients. The study initially included a 2 x 2 x 2 eight-cell design. This article relates our experience adding a ninth treatment condition (Cell 9), consisting of CBI alone, with no pills or MM. By comparing patients receiving CBI alone to patients receiving two placebos, MM and CBI, we can examine the strength of the placebo effect for these two medications in alcohol-dependent patients. Moreover, we can study CBI in the context in which it is frequently delivered clinically, that is, in the absence of pharmacotherapy and certainly in the absence of placebo medication. RESULTS: This article explains the background and rationale behind the decision to include Cell 9 in COMBINE. Recruitment challenges faced as a result of adding this condition are reviewed, as is the experience implementing this condition in a pilot feasibility study. CONCLUSIONS: The use of a "psychotherapy with no pills" treatment condition as part of a combined pharmacotherapy-psychotherapy study of alcohol dependence is feasible and can help enrich the results of this research.

Sustaining motivational interviewing: a meta-analysis of training studies.

BACKGROUND AND AIMS: Previous research indicates that motivational interviewing (MI) skills decline over time among participants in training workshops when post-workshop feedback and coaching are not provided. This study explored moderators of skill retention among trainees learning MI mainly for substance use disorder treatment in real-world treatment settings, including workshop enhancements and type and dose of post-workshop feedback and coaching. METHODS: A meta-analysis of training studies was conducted with studies that reported MI skills using observational measures and that included trainees from real-world agency settings. Standardized change scores were calculated to indicate the magnitude of pre-post training change in MI skills; standardized change scores from post-training to 3 and 6+ months follow-up were calculated to indicate the sustainability of training gains over time. Effect sizes were aggregated using random effects models. RESULTS: Twenty-one papers that reported the effects of MI training on agency staff were included in this review. Across studies, training yielded gains in MI skills (d = 0.76). Studies that did not include feedback and/or coaching reported eroding skills over a 6-month follow-up (d = -0.30), whereas post-workshop feedback/coaching sustained skills (d = 0.03). Effects of post-workshop feedback/coaching were moderated by frequency, duration and length of training. Moreover, studies reporting low levels of attrition from training protocols showed small increases in skills over the 6-month follow-up period (d = 0.12), whereas studies with high attrition showed skill erosion (d = -0.29). CONCLUSIONS: On average, three to four feedback/coaching sessions over a 6-month period sustain skills among trainees for motivational interviewing, mainly for substance use disorder treatment. However, high rates of attrition from feedback/coaching contributes to post-workshop skill erosion.

Alcohol treatment effects on secondary nondrinking outcomes and quality of life: the COMBINE study.

OBJECTIVE: To evaluate the full range of alcohol treatment effectiveness, it is important to assess secondary nondrinking outcome dimensions in addition to primary alcohol consumption outcomes. METHOD: We used a large sample (n=1,226) of alcohol-dependent participants entering the National Institute on Alcohol Abuse and Alcoholism-sponsored COMBINE (Combining Medications and Behavioral Interventions) Study, a multisite clinical trial of pharmacological (naltrexone [ReVia] and acamprosate [Campral]) and behavioral interventions, to examine the effects of specific treatment combinations on nondrinking functional outcomes. We assessed the outcomes at baseline and at the end of 16 weeks of alcohol treatment and again at the 26-week and/or 52-week postrandomization follow-ups. RESULTS: (1) Drinking and secondary outcomes were significantly related, especially at the follow-up periods. A higher percentage of heavy drinking days, more drinks per drinking day, and lower percentage of days abstinent were associated with lower quality-of-life measures. (2) All nondrinking outcomes showed improvement at the end of 16 weeks of treatment and most maintained improvement over the 26-week and 52-week follow-ups. Only two measures returned to pretreatment levels at 52 weeks: percentage of days paid for work and physical health. Improvements of nondrinking outcomes remained even after adjusting for posttreatment heavy drinking status. (3) Although nondrinking outcomes showed overall improvement, specific pharmacological and behavioral treatment combinations were not differentially effective on specific secondary outcomes. CONCLUSIONS: In the current study, changes that resulted from treatment were multidimensional, and improvements in nondrinking outcomes reflected the overall significant improvement in drinking but they were not differentiated between treatment combination groups. Findings from this study support the importance of including secondary nondrinking outcomes in clinical alcohol-treatment trials.

Addressing substance abuse in health care settings.

This article summarizes the proceedings of a roundtable discussion at the 2005 annual meeting of the Research Society on Alcoholism in Santa Barbara, California. The chair was William R. Miller. The presentations were as follows: (1) Screening and Brief Intervention for Alcohol Problems, by Allen Zweben; (2) Three Intervention Models and Their Impact on Medical Records, by Denise Ernst; (3) Pharmacotherapies for Managing Alcohol Dependence in Health Care Settings, by Roger D. Weiss; (4) The Trauma Center as an Opportunity, by Carol R. Schermer; (5) Motivational Interviewing by Telephone and Telemedicine, by Catherine Baca; (6) Health Care as a Context for Treating Drug Abuse and Dependence, by Wilson M. Compton; and (7) Interventions for Heavy Drinking in Health Care settings: Barriers and Strategies, by Mark L. Willenbring.

Applying clinical significance methodology to alcoholism treatment trials: determining recovery outcome status with individual- and population-based measures.

BACKGROUND: The current analysis applies clinical significance methodology to alcoholism treatment outcome research using data available from Project MATCH. Because of its high internal validity and its inclusion of multiple measures assessing multiple outcome dimensions, MATCH was considered an ideal study to explore the utility of this methodology. METHODS: Data reported here are from a total of 1,726 participants enrolled in either aftercare (n = 774) or outpatient (n = 952) arms of the study. First, a cutoff score was determined differentiating functional versus dysfunctional status on three outcome measures: percent days abstinent (PDA), mean drinks per drinking day (DDD) and negative consequences of alcohol use. Second, the reliable change in pre- to post-treatment scores on these three measures was calculated. RESULTS: The results reported herein support the importance of distinguishing between statistical and clinical significance of outcomes. During three months post-treatment, approximately one-half of the treated patients were "recovered" (i.e., both functional and reliably changed) with respect to both PDA (i.e., 51%) and negative consequences of drinking (i.e., 47%); however, only about one-third of individuals remained recovered throughout the full one-year follow-up period (i.e., 33% on PDA and 35% on negative consequences). These individual-based change outcomes compared similarly to a population-based indicator of heavy drinking. Alternatively, only about one-quarter of participants were recovered using two distinct criteria for mean DDD (i.e., 23-29%), and even fewer participants remained recovered on mean DDD over the full one-year follow-up period (i.e., about 14-18%). CONCLUSIONS: Based on study limitations, more work is required to make clinical significance methodology practically useful to alcoholism treatment trials including more precise definitions of functional status and relative change as well as better interpretation of the inter-relationship between multiple measures assessing multiple outcome domains.

Clinical and methodological utility of a composite outcome measure for alcohol treatment research.

BACKGROUND: How to capture different response patterns resulting from alcohol treatment has been a troublesome issue for alcohol researchers. A composite measure is one approach to capturing multiple treatment outcomes among diverse client populations. This article provides the rationale, development, and work conducted thus far on the composite outcome index and discusses the clinical utility of the measure. METHODS: With the use of Project MATCH data, the composite outcome measure was examined in relation to self-reported alcohol consumption and alcohol problems and biological markers as well as in relation to other areas of functioning, such as psychiatric dysfunction and quality of life. Also, for assessing the stability of the measure, different composite outcomes statuses were assessed over time. RESULTS: Individuals with better scores on composite outcome index had fewer percent days abstinent, consumed more alcohol when they drank, had a greater number of alcohol problems, and evidenced higher blood levels as measured by gamma-glutamyltranspeptidase and carbohydrate-deficient transferrin. Individuals with poorer composite outcome statuses had poorer social and behavioral role functioning and mental and physical health-related quality of life. Findings on short- and long-term composite outcome statuses revealed that only a minority of clients (30%) sustained a remitted status (i.e., abstinent or moderate drinking without problems) over the 1-year follow-up, and fully 70% of the clients had reached a nonremitted status (i.e., heavy drinking and/or problems) on the composite measure at one or more time points during the 12-month follow-up. CONCLUSIONS: The composite outcome index could be used usefully along with singular measures of consumption to obtain a more complete picture of what has occurred among clients posttreatment. Future work will involve the testing of the composite outcome index with other client populations and/or different treatments to further our understanding of the varying response patterns found among alcohol-dependent clients.