Do patients with alcohol dependence respond to placebo? Results from the COMBINE Study.

Objective: The purpose of this study was to examine the nature of the effect of placebo medication plus accompanying medical management in the treatment of alcohol dependence.

Method: The National Institute on Alcohol Abuse and Alcoholism COMBINE (Combining Medications and Behavioral Interventions) study, a randomized controlled double-blind trial of 1,383 alcohol-dependent patients, compared combinations of medications (acamprosate [Campral] and naltrexone [ReVia]) and behavioral therapy (medical management and specialist-delivered behavioral therapy) for alcohol dependence. This report focuses on a subset of that study population (n = 466) receiving (1) specialized behavioral therapy alone (without pills), (2) specialized behavioral therapy + placebo medication + medical management, or (3) placebo + medical management.

Combined pharmacotherapies and behavioral interventions for alcohol dependence (The COMBINE Study): examination of posttreatment drinking outcomes.

Objective: The aim of this study was to examine the efficacy of pharmacological and behavioral interventions across 1 year posttreatment in the COMBINE (Combining Medications and Behavioral Interventions) Study.

Method: Alcohol-dependent individuals (N = 1,383; 428 women) recruited at 11 outpatient academic alcoholism-treatment clinics across the United States participated in a randomized, double-blind, placebo-controlled trial. They received 16 weeks of naltrexone (Revia) or acamprosate (Campral) or both medications and/or placebos in combination with medical management (MM), with or without combined behavioral intervention (CBI); one group received CBI without pills or MM.

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.

How pilot studies improve large-scale clinical trials: lessons learned from the COMBINE Study.

Objective: The design of a clinical trial to evaluate a potential therapy requires decisions about issues that include safety, efficacy, measurement, feasibility and training. Experience from the COMBINE Study, which tests the combination of medications and behavioral therapies for alcohol dependence, is presented as an example of how pilot studies improve large-scale clinical trials.

Method: The COMBINE Pilot 1 inpatient study was designed to inform the main trial about the safety and tolerability of the doses of acamprosate (3 g/day) and naltrexone (100 mg/day) selected for study, alone and in combination.

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.

Design and analysis of trials of combination therapies.

Objective: Combination therapies can have significant advantages over monotherapies. Combinations of therapies can provide additive (or even synergistic) effects on efficacy. They may permit use of lower doses of each component to achieve a given level of efficacy, improving tolerability and reducing adverse effects.

Factorial designs in clinical trials: options for combination treatment studies.

Objective: This study reviews the use of factorial designs in clinical trials investigating combinations of therapies.

Method: Factorial designs may be used when (1) the factors are regarded as being independent or (2) the factors are thought to be complementary and a specific aim is to investigate these interactions. We describe what is meant by a factorial design and the issues that need to be addressed when using such a design.

Aspects of social support associated with depression at hospitalization and follow-up assessment among cardiac patients.

Purpose: High levels of depressive symptoms have been shown to affect the morbidity, mortality, and functioning of patients with myocardial infarction (MI). Findings have shown that social support is associated with depression in both patient and community samples. This study examined various aspects of social support as they relate to depressive symptoms in patients with MI, both in the hospital and 2 weeks later.

A randomized controlled trial of a public health nurse directed treatment program for rural patients with high blood cholesterol.

Background: Many rural residents do not have access to high-quality nutrition counseling for high blood cholesterol. The objective of this study was to assess the effectiveness of an intervention program designed to facilitate dietary counseling for hypercholesterolemia by rural public health nurses.

Methods: Eight health departments (216 participants) were randomized to give the special intervention (SI) and nine (252 participants) to give the minimal intervention (MI).