Search

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., THE EFFECTIVENESS OF ALCOHOL TREATMENT is typically measured by examining the differences and/or changes in alcohol consumption as the primary outcome dimension (Babor et al., 1994; Finney et al., 2003; [...]

A study to evaluate the efficacy of medication, behavioral therapies, and their combinations for treatment of alcohol dependence and to evaluate placebo effect on overall outcome is presented. A positive effect of receiving placebo medication and medical management over and above that seen with specialist-delivered behavioral therapy alone is observed and so medical management of alcohol dependence with naltrexone appears to be feasible.

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., THE PURPOSE OF this article is to provide a description of the paramount issues, constraints, dilemmas and options available that affected the development and final product of Combined Behavioral Intervention [...]

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., ALTHOUGH QUALITY OF LIFE (QoL) has always been an underlying concern of both patients and clinicians, its use as a formal concept and measurement objective has become firmly established in [...]

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., THE COMBINE Study, a nationwide, multisite trial, was initiated in 1997 to test combinations of two promising medications, naltrexone and acamprosate, and two behavioral treatments, low intensive Medical Management and [...]

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., THE USE OF placebos in medication trials is widespread, although controversial (Bok, 1974; Rothman and Michels, 1994). Placebos are used in studies of untested phamaacological treatments because of evidence that [...]

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., THE MULTISITE COMBINE Study brought together a team of alcoholism investigators from two rather different backgrounds. About half of the clinical research centers, as well as the coordinating center, had [...]

Objective: As a first step in a thorough cost-effectiveness analysis of a randomized alcohol-treatment-matching trial (Project MATCH), the present study examines the relative costs of three manual-guided, individually delivered treatments and the costs of replicating them in nonresearch settings. Method: Costs of delivering a 12-session Cognitive Behavioral Therapy (CBT), a 4-session Motivational Enhancement Therapy (MET) and a 12-session Twelve-Step Facilitation (TSF) treatment over 12 weeks were assessed for three treatment sites at two of the nine Project MATCH locations (Milwaukee, WI, and Providence, RI). Research cost calculations included clinical, administrative and training/supervision variables in determining total treatment costs, average cost per contact hour and average cost per research participant. Investigators from all nine MATCH locations estimated direct clinical costs, administrative overhead costs and training/supervision costs for replicating these treatments. Results: For Project MATCH, MET cost twice as much or more per patient contact hour (mean = $498) than CBT (mean = $198) and TSF (mean = $253) but was less costly per research participant (mean = $1,700) than both CBT (mean = $1,901) and TSF (mean = $1,969). For clinical replication, high end per patient costs ranged from $512 for MET to $750 for TSF to $788 for CBT: a cost savings for MET of $238 (32%) over TSF and $276 (35%) over CBT. Conclusions: As part of a randomized clinical trial, MATCH treatments are costly to produce. However, when estimates are used to project these costs to nonresearch clinical settings, the costs are greatly reduced. Whereas MET appears to be much less costly to deliver in nonresearch settings than the other two treatments, the estimated cost differentials are less than the 1:3 treatment session ratio for MET versus TSF or CBT. (J. Stud. Alcohol 59: 503-512, 1998), A study concerning alcohol-treatment-matching trial (Project MATCH) was conducted to find out the relative cost of three manual-guided, individually delivered treatments, and the cost of replicating the study in a non-research environment. The study found that when estimates are used to predict the cost in a non-research clinical setting, costs are reduced. Furthermore, Motivational Enhancement Therapy costs less if conducted in a non-research environment., IN THIS AGE of managed care, alcohol treatment costs are a matter of concern, not only to treatment providers and insurance carriers, but also to policy makers, clinicians and patients. [...]

Project MATCH (Matching Alcoholism Treatments to Client Heterogeneity) is a multisite collaborative project designed to evaluate patient-treatment interactions in alcoholism treatment. To evaluate whether major threats to the internal validity of the independent (treatment) variable in Project MATCH could be ruled out, we investigated several aspects of treatment integrity and discriminability. In this study, 1,726 alcohol-dependent participants at 10 sites were randomized to 3 treatments: cognitive-behavioral treatment (CBT), motivational enhancement therapy (MET), and 12-step facilitation (TSF). Participants received treatment either as outpatients or as aftercare following a more intensive inpatient or day hospital treatment. For both the outpatient and aftercare arms of the study, treatments were discriminable in that therapists implemented each of the treatments according to manual guidelines and rarely used techniques associated with comparison approaches. Participants received a high level of exposure to their study treatments, and the intended contrast in treatment dose between MET and the 2 more intensive treatments (CBT and TSF) was obtained. Alcoholics Anonymous involvement was significantly higher for participants assigned to TSF versus MET or CBT, whereas the treatments did not differ in utilization of other nonstudy treatments. Nonspecific aspects of treatment such as therapist skillfulness and level of the therapeutic alliance were comparable across treatment conditions.

Treatment matching research is influenced by the heterogeneity of the patients and their responses to the various methods of treatment. The preservation of the integrity of treatment and the differentiation between the treatments is dependent on restrictions on study treatment. The Project MATCH, a national multisite study of matching clients to alcohol treatment, is used as a platform to analyze the various methods used to protect treatment integrity during the treatment of a heterogeneous sample of alcoholics. The issues focussed on include development of clinical care guidelines, selection criteria for therapists and strategies for treating a variety of alcoholics within a particular approach.

Several approaches for the treatment of alcohol abuse and dependence exist but it is impossible to include all the approaches in the research studies of treatment matching. The present study focuses on the various issues to be taken into consideration such as the methods of treatment, of therapy and treatment setting when framing a research study. The Project MATCH, a natural multisite study on matching clients to alcohol treatment, provides a platform for analyzing the methodological and practical issues raised and the approaches used in the treatment matching research.

An analysis of the problems involved in making decisions about the selection and recruitment of subjects for treatment matching research reveals that it is a complicated method which requires conceptual, methodological and practical considerations. The project MATCH, a multisite client-treatment matching trial, highlights the various issues involved in decision-making. The success of a multisite trial depends on the selection of proper recruitment strategies and eligibility criteria, contingency planning and effective implementation of the treatment methods.

An analysis of issues such as drinking as an underlying unitary disorder, empirical associations among drinking outcome measures, procedures to be used to detect, correct or prevent response bias, conducted to select alcohol-related outcome measures in alcoholism treatment research revealed that no one particular outcome measurement will suit all treatment research. Two primary dependent measures which focus on the proportion of available drinking days, abstinence and intensity of drinking defined by total drink consumed during follow-up period divided by the number of actual drinking days are suggested. The study also provides guidelines in the selection of outcome measures for future research.

Addresses clinical and methodological issues in conducting the Marital Systems Study, a research project evaluating the efficacy of systems-oriented conjoint treatment with couples in which one spouse is abusing alcohol. These include standardizing and monitoring the intervention and developing an interactional perspective on the alcohol-related difficulties. (Author/JAC)

LITTLE IS KNOWN about the best methods for conducting treatment outcome research on combining pharmacological and behavioral interventions to develop optimal treatments for alcohol dependence. To facilitate this type of [...]

Aims. This paper examines the costs of medical care prior to and following initiation of alcoholism treatment as part of a study of patient matching to treatment modality. Design. Longitudinal study with pre- and post-treatment initiation. Measurements. The total medical care costs for inpatient and outpatient treatment for patients participating over a span of 3 years post-treatment. Setting. Three treatment sites at two of the nine Project MATCH locations (Milwaukee, WI and Providence, RI). Participants. Two hundred and seventy-nine patients. Intervention. Patients were randomly assigned to one of three treatment modalities: a 12-session cognitive behavioral therapy (CBT), a four-session motivational enhancement therapy (MET) or a 12-session Twelve-Step facilitation (TSF) treatment over 12 weeks. Findings. Total medical care costs declined from pre- to post-treatment overall and for each modality. Matching effects independent of clinical prognosis showed that MET has potential for medical-care cost-savings. However, patients with poor prognostic characteristics (alcohol dependence, psychiatric severity and/or social network support for drinking) have better cost-savings potential with CBT and/or TSF. Conclusions. Matching variables have significant importance in increasing the potential for medical-care cost-reductions following alcoholism treatment. [ABSTRACT FROM AUTHOR]

The increasing use of media advertisements to recruit subjects in alcohol treatment research has raised concerns about the comparability of such solicited subjects and subjects drawn from more traditional clinic populations. This papers based on a study that involved both solicited and clinic subjects, identifies differences between the two types of subjects in terms of sociodemographic variables; pre-treatment drinking and marital adjustment' several dimensions of 'self-definition'; and three outcome' measures. These findings suggest' that there may be significant differences between solicited and clinic subjects and that these differences should be taken into account in the design of studies utilizing solicited subjects in order to determine the generalizability of the results. [ABSTRACT FROM AUTHOR]