Open trials as a method of prioritizing medications for inclusion in controlled trials for cocaine dependence

This paper describes a rapid and systematic method of using open trials to identify medications that may be useful for the treatment of cocaine dependence. Results of these open trials can be used to prioritize medications for inclusion in subsequent double-blind, placebo-controlled trials. Prelimin...

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Bibliographic Details
Published in:Addictive behaviors 1999-03, Vol.24 (2), p.287-291
Main Authors: Kampman, Kyle M, Rukstalis, Margaret, Ehrman, Ronald, Mcginnis, David E, Gariti, Peter, Volpicelli, Joseph R, Pettinati, Helen, O’Brien, Charles P
Format: Article
Language:English
Subjects:
Addictions
Adult
Analysis of Variance
Anti-Anxiety Agents - therapeutic use
Antidepressive Agents, Second-Generation - therapeutic use
Biological and medical sciences
Clinical trials
Cocaine
Cocaine-Related Disorders - drug therapy
Controlled Clinical Trials as Topic - methods
Drug addictions
Evidence-Based Medicine - methods
Female
Humans
Male
Medical sciences
Middle Aged
Patient Compliance
Pilot Projects
Propranolol - therapeutic use
Prospective Studies
Research Design
Substance abuse treatment
Survival Analysis
Toxicology
Treatment Outcome
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Summary:This paper describes a rapid and systematic method of using open trials to identify medications that may be useful for the treatment of cocaine dependence. Results of these open trials can be used to prioritize medications for inclusion in subsequent double-blind, placebo-controlled trials. Preliminary results are presented from the evaluation of propranolol, nefazodone, and the combination of phentermine and fenfluramine (phen/fen). Each medication was evaluated in an open trial, and results were compared to results obtained from a group that received a multivitamin. Outcome measures included treatment retention, urine toxicology screens, self-reported cocaine use, and changes on the Addiction Severity Index (ASI). Treatment retention was significantly better in the propranolol group than in the multivitamin group. Concurrent alcohol abuse was associated with increased rates of attrition in the multivitamin group, and the phen/fen group, but not in the propranolol group. Neither the nefazodone nor the phen/fen groups showed any outcome advantages over the multivitamin group. We conclude that propranolol may enhance retention among cocaine-dependent patients, especially among those who also abuse alcohol. These results encourage a double-blind, placebo-controlled trial of propranolol.
ISSN:0306-4603
1873-6327
DOI:10.1016/S0306-4603(98)00040-9