Marston E Youngblood, Kelly T Murray, Eric Devine, Patricia K Latham, Sandra Hubatch
{"title":"Coordinating and monitoring multisite clinical trials that combine pharmacological and behavioral treatments.","authors":"Marston E Youngblood, Kelly T Murray, Eric Devine, Patricia K Latham, Sandra Hubatch","doi":"10.15288/jsas.2005.s15.82","DOIUrl":"https://doi.org/10.15288/jsas.2005.s15.82","url":null,"abstract":"<p><strong>Objective: </strong>Coordination of a large, multicenter Phase 3 clinical trial is critical to the success of the trial. The focus of this article is to describe the special challenges involved in the coordination of the 11 clinical centers conducting the COMBINE clinical trial and to discuss the challenges of monitoring the information collected on the 1,383 participants enrolled in this trial.</p><p><strong>Method: </strong>The role of the coordinating center in working with the clinical sites is to ensure both high data quality and that the intervention protocol is conducted with appropriate attention paid to patient safety and consistency across sites. To satisfy those goals, a research committee of investigators and coordinating center staff was formed. The committee monitored adverse event reporting, participant safety, recruitment, delivery of the interventions, collection of assessments and completeness and timeliness of transfer of data to the coordinating center. Objective measures of performance were determined for each criterion to provide the principal investigators, study sponsor and Data and Safety Monitoring Board with feedback on conduct of the trial. Site performance as defined by these criteria was evaluated periodically, with both detailed written and verbal feedback provided to each investigator and study coordinator.</p><p><strong>Results: </strong>The system was successful in detecting sites with performance issues, providing feedback to site personnel and measuring improvement. Study leadership, clinical center staff and coordinating center staff felt that the procedures for identifying and solving performance issues worked well and improved overall performance.</p><p><strong>Conclusions: </strong>Establishing an organizational structure that provided (1) leadership, (2) a venue for communication, (3) performance criteria and (4) a process for monitoring performance goals and providing feedback has enabled COMBINE to achieve success in reaching these markers of clinical trial practice.</p>","PeriodicalId":17056,"journal":{"name":"Journal of studies on alcohol. Supplement","volume":" 15","pages":"82-91; discussion 65"},"PeriodicalIF":0.0,"publicationDate":"2005-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.15288/jsas.2005.s15.82","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25646342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
William R Miller, Theresa B Moyers, Lisa Arciniega, Denise Ernst, Alyssa Forcehimes
{"title":"Training, supervision and quality monitoring of the COMBINE Study behavioral interventions.","authors":"William R Miller, Theresa B Moyers, Lisa Arciniega, Denise Ernst, Alyssa Forcehimes","doi":"10.15288/jsas.2005.s15.188","DOIUrl":"https://doi.org/10.15288/jsas.2005.s15.188","url":null,"abstract":"<p><strong>Objective: </strong>Current standards for clinical trials require that behavioral interventions be thoroughly specified, that clinicians be well trained and closely supervised and that performance be carefully monitored to ensure and document treatment fidelity. This article describes procedures developed and implemented for this purpose in the COMBINE Study, a multisite trial combining medications and behavioral interventions for alcohol dependence.</p><p><strong>Method: </strong>Two behavioral treatments were tested in COMBINE: a Medical Management (MM) protocol to accompany the delivery of trial medications and a Combined Behavioral Intervention (CBI) designed as a comprehensive and flexible evidence-based psychotherapy.</p><p><strong>Results: </strong>Information is provided concerning (1) screening and qualifications of practitioners, (2) training and certification in the interventions, (3) on-site supervision and coordination of the two treatments, (4) central monitoring and coding of treatment sessions and (5) maintenance and documentation of treatment fidelity.</p><p><strong>Conclusions: </strong>Both interventions were delivered with fidelity. Problems encountered and important choices made in the implementation of training and quality assurance for CBI and MM are briefly described.</p>","PeriodicalId":17056,"journal":{"name":"Journal of studies on alcohol. Supplement","volume":" 15","pages":"188-95; discussion 168-9"},"PeriodicalIF":0.0,"publicationDate":"2005-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.15288/jsas.2005.s15.188","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25633638","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dennis Donovan, Margaret E Mattson, Ron A Cisler, Richard Longabaugh, Allen Zweben
{"title":"Quality of life as an outcome measure in alcoholism treatment research.","authors":"Dennis Donovan, Margaret E Mattson, Ron A Cisler, Richard Longabaugh, Allen Zweben","doi":"10.15288/jsas.2005.s15.119","DOIUrl":"https://doi.org/10.15288/jsas.2005.s15.119","url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>QoL represents an important area to consider in assessing individuals with alcohol use disorders and in evaluating alcoholism treatment outcome.</p>","PeriodicalId":17056,"journal":{"name":"Journal of studies on alcohol. Supplement","volume":" 15","pages":"119-39; discussion 92-3"},"PeriodicalIF":0.0,"publicationDate":"2005-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.15288/jsas.2005.s15.119","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25633693","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Combining treatments for alcoholism: why and how?","authors":"Margaret E Mattson, Raye Z Litten","doi":"10.15288/jsas.2005.s15.8","DOIUrl":"https://doi.org/10.15288/jsas.2005.s15.8","url":null,"abstract":"<p><p>Treatment of alcohol disorders through the use of combinations of pharmacological and behavioral modalities may more effectively address the multicomponent nature of the disorder than single-modality approaches. Interdisciplinary models of the biological, psychological and social components of alcohol disorders are emerging rapidly from basic research, and treatment researchers have begun to test various strategies to combine medications and behavioral treatments. In addition to behavioral and pharmacological combinations, effective treatment pairs can be composed of two medications whose mechanisms of action are believed to be compatible and potentially additive, or even synergistic. Combining Medications and Behavioral Interventions (COMBINE) is a large multisite clinical trial sponsored by the National Institute on Alcohol Abuse and Alcoholism. Its goal is to determine if improvements in treatment outcome for alcohol dependence can be achieved by combining pharmacotherapy and behavioral interventions. Under evaluation is the efficacy of two promising medications (naltrexone and acamprosate), both singly and together, when used in conjunction with two behavioral treatments of differing intensities. This supplement describes in detail the methods and rationale for the approach taken in COMBINE. This first article in the supplement has three objectives: (1) to review strategies for conducting combination treatment studies as illustrated with selected examples from the literature, (2) to summarize the main design features of COMBINE as background for the articles in this supplement and (3) to comment on future directions for combination treatment research as the field moves beyond COMBINE.</p>","PeriodicalId":17056,"journal":{"name":"Journal of studies on alcohol. Supplement","volume":" 15","pages":"8-16; discussion 6-7"},"PeriodicalIF":0.0,"publicationDate":"2005-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.15288/jsas.2005.s15.8","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25654755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Allen Zweben, David Barrett, Lisa Berger, Kelly Tobin Murray
{"title":"Recruiting and retaining participants in a combined behavioral and pharmacological clinical trial.","authors":"Allen Zweben, David Barrett, Lisa Berger, Kelly Tobin Murray","doi":"10.15288/jsas.2005.s15.72","DOIUrl":"https://doi.org/10.15288/jsas.2005.s15.72","url":null,"abstract":"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.","PeriodicalId":17056,"journal":{"name":"Journal of studies on alcohol. Supplement","volume":" 15","pages":"72-81; discussion 65"},"PeriodicalIF":0.0,"publicationDate":"2005-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.15288/jsas.2005.s15.72","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25646341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
William R Miller, Joseph S Locastro, Richard Longabaugh, Stephanie O'Malley, Allen Zweben
{"title":"When worlds collide: blending the divergent traditions of pharmacotherapy and-psychotherapy outcome research.","authors":"William R Miller, Joseph S Locastro, Richard Longabaugh, Stephanie O'Malley, Allen Zweben","doi":"10.15288/jsas.2005.s15.17","DOIUrl":"https://doi.org/10.15288/jsas.2005.s15.17","url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":17056,"journal":{"name":"Journal of studies on alcohol. Supplement","volume":" 15","pages":"17-23; discussion 6-7"},"PeriodicalIF":0.0,"publicationDate":"2005-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25654758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Measurement and choice of drinking outcome variables in the COMBINE Study.","authors":"Raymond E Anton, Carrie L Randall","doi":"10.15288/jsas.2005.s15.104","DOIUrl":"https://doi.org/10.15288/jsas.2005.s15.104","url":null,"abstract":"<p><strong>Objective: </strong>The COMBINE Study, a federally funded multisite clinical trial, endeavored to choose drinking and related outcome variables that were scientifically sound and had both convergent validity with previously published studies and face validity for clinical meaning. This article describes these variables and the methods used to collect them.</p><p><strong>Method: </strong>In choosing the primary outcome drinking variables, the mechanisms of action of naltrexone and acamprosate were considered along with previously published results for them and the psychosocial therapies utilized (Project MATCH). In addition, enough previous data were required to abstract meaningful power calculations for sample size estimates. Attention was paid to methodological detail in collection of drinking data, and confirmatory biological variables (carbohydrate deficient transferrin and gamma glutamyl transpeptidase) were incorporated into the study design.</p><p><strong>Results: </strong>Daily standard drinks were collected by calendar-based methods with a stated goal of 90% within-treatment drinking data to be collected. \"Percentage of days abstinent\" and \"time to first heavy drinking day\" were chosen as primary outcome variables. Standardized daily alcohol consumption data can be applied to various statistical approaches, including hierarchical linear modeling and multiple relapse event analyses, which can evaluate a progression of improvement or worsening over time.</p><p><strong>Conclusions: </strong>Trained individuals using calendar-based methods attempting to collect all daily drinking data, independent of treatment dropout, should enhance interpretive validity of treatment differences. Convergence of drinking data with biological marker changes, quality of life, craving and health services utilization will enhance the overall validity of both the within-treatment and the posttreatment results for the COMBINE Study.</p>","PeriodicalId":17056,"journal":{"name":"Journal of studies on alcohol. Supplement","volume":" 15","pages":"104-9; discussion 92-3"},"PeriodicalIF":0.0,"publicationDate":"2005-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.15288/jsas.2005.s15.104","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25633691","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ron A Cisler, Daniel R Kivlahan, Dennis Donovan, Margaret E Mattson
{"title":"Assessing nondrinking outcomes in combined pharmacotherapy and psychotherapy clinical trials for the treatment of alcohol dependence.","authors":"Ron A Cisler, Daniel R Kivlahan, Dennis Donovan, Margaret E Mattson","doi":"10.15288/jsas.2005.s15.110","DOIUrl":"https://doi.org/10.15288/jsas.2005.s15.110","url":null,"abstract":"<p><strong>Objective: </strong>This article argues that nondrinking outcomes are essential to include in complex trials such as COMBINE to assess the hypothesized mechanisms of action and behavioral change associated with both medications and psychotherapy. Toward this end, COMBINE is used as a case study for (1) discussing hypothesized mechanisms of action for behavior change, (2) discussing distinctive design features of combined studies, (3) highlighting issues in the selection of outcome measures, (4) providing a framework for organizing outcome domains and measures and (5) providing a dose-response model for assessing alcoholism treatment outcomes.</p><p><strong>Method: </strong>A review of the literature and discussion of methodological issues in assessing nondrinking outcomes is provided as well as a case study in developing a conceptual framework for selecting outcome measures.</p><p><strong>Results: </strong>The results of the review and case study include the development of a framework for categorizing outcome dimensions and measures into condition-specific clinical status, condition-specific symptoms and personal and interpersonal functioning outcomes. In addition, a model is provided for assessing the dose-response of combined alcoholism treatment with multiple dimensions of outcome during and after treatment.</p><p><strong>Conclusions: </strong>Consistent with previous observations that recovery from alcohol dependence is a multidimensional developmental process, the COMBINE Study will examine the effects of different combinations of pharmacotherapy and behavioral interventions on the magnitude and pattern of changes in various outcome dimensions (both drinking and nondrinking) over time.</p>","PeriodicalId":17056,"journal":{"name":"Journal of studies on alcohol. Supplement","volume":" 15","pages":"110-8; discussion 92-3"},"PeriodicalIF":0.0,"publicationDate":"2005-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.15288/jsas.2005.s15.110","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25633692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Rationale for combining acamprosate and naltrexone for treating alcohol dependence.","authors":"Barbara J Mason","doi":"10.15288/jsas.2005.s15.148","DOIUrl":"https://doi.org/10.15288/jsas.2005.s15.148","url":null,"abstract":"<p><strong>Objective: </strong>This article provides an evidence-based review of acamprosate and naltrexone, used alone and in combination. Both medications are gaining increasing availability worldwide by prescription for the treatment of alcohol dependence. There is scientific and clinical interest in examining these drugs in combination, given their high tolerability, moderate effect sizes, different pharmacological profiles and potentially different effects on drinking outcomes.</p><p><strong>Method: </strong>This article includes a review of the key similarities and differences between acamprosate and naltrexone in the treatment of alcohol dependence; the published double-blind, placebo-controlled trials of acamprosate and naltrexone across a uniform range of outcome criteria to elucidate the differences and similarities in the behavioral effects of these drugs; the two published pharmacokinetic and pharmacodynamic drug interaction studies of acamprosate and naltrexone; and the single-site clinical trial of acamprosate and naltrexone used alone and in combination relative to placebo.</p><p><strong>Results: </strong>Pharmacokinetic and pharmacodynamic studies report an increase in acamprosate plasma levels with no clinically significant elevation in adverse events when the two drugs are used in combination. Data from dose-response studies for acamprosate alone suggest that the augmentation of acamprosate plasma levels by co-administration of naltrexone may have clinical benefits.</p><p><strong>Conclusions: </strong>These factors support investigating the efficacy and safety of combining acamprosate and naltrexone for the treatment of alcohol dependence in a large-scale multisite trial, with evaluation of potential predictors of response to each drug alone and in combination relative to placebo.</p>","PeriodicalId":17056,"journal":{"name":"Journal of studies on alcohol. Supplement","volume":" 15","pages":"148-56; discussion 140"},"PeriodicalIF":0.0,"publicationDate":"2005-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.15288/jsas.2005.s15.148","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25633695","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Roger D Weiss, Joseph S Locastro, Robert Swift, Allen Zweben, William R Miller, Richard Longabaugh, James D Hosking
{"title":"Use of a \"psychotherapy with no pills\" treatment condition as part of a combined pharmacotherapy-psychotherapy research study of alcohol dependence.","authors":"Roger D Weiss, Joseph S Locastro, Robert Swift, Allen Zweben, William R Miller, Richard Longabaugh, James D Hosking","doi":"10.15288/jsas.2005.s15.43","DOIUrl":"https://doi.org/10.15288/jsas.2005.s15.43","url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":17056,"journal":{"name":"Journal of studies on alcohol. Supplement","volume":" 15","pages":"43-9; discussion 33"},"PeriodicalIF":0.0,"publicationDate":"2005-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25646337","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}