title: Open trials as a method of prioritizing medications for inclusion in controlled trials for cocaine dependence.
abstract: 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.
authors.affiliation: Department of Psychiatry, University of Pennsylvania School of Medicine, USA. kampman@research.trc.upenn.edu
authors.forename: K M
authors.initials: KM
authors.lastname: Kampman
authors.forename: M
authors.initials: M
authors.lastname: Rukstalis
authors.forename: R
authors.initials: R
authors.lastname: Ehrman
authors.forename: D E
authors.initials: DE
authors.lastname: McGinnis
authors.forename: P
authors.initials: P
authors.lastname: Gariti
authors.forename: J R
authors.initials: JR
authors.lastname: Volpicelli
authors.forename: H
authors.initials: H
authors.lastname: Pettinati
authors.forename: C P
authors.initials: CP
authors.lastname: O'Brien
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D014151:Anti-Anxiety Agents / Q000627:therapeutic use*; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use; D019970:Cocaine-Related Disorders / Q000188:drug therapy*; D018849:Controlled Clinical Trials as Topic / Q000379:methods; D019317:Evidence-Based Medicine / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010865:Pilot Projects; D011433:Propranolol / Q000627:therapeutic use*; D011446:Prospective Studies; D012107:Research Design; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D014151:Anti-Anxiety Agents; D018687:Antidepressive Agents, Second-Generation; D011433:Propranolol