Pilot randomized double blind placebo-controlled study of dexamphetamine for cocaine dependence.

Abstract

AIMS:

To establish the feasibility of conducting a placebo-controlled clinical trial of dexamphetamine replacement therapy for cocaine dependence and to obtain preliminary data.

DESIGN:

Double-blind randomized placebo-controlled trial.

PARTICIPANTS:

Thirty cocaine-dependent injecting drug users.

INTERVENTION:

Subjects were assigned randomly to receive 60 mg/day dexamphetamine (n = 16) or placebo (n = 14) for 14 weeks.

MEASUREMENTS:

Immunoassay and mass spectrometric techniques were used to identify cocaine metabolites in urine. Subjects were screened using the Composite International Diagnostic Interview and DSM-IV. The Opiate Treatment Index, Brief Symptom Inventory, Severity of Dependence Scale and visual analogue craving scales were used to collect pre- and post-self-report data.

FINDINGS:

Treatment retention was equivalent between groups; however, outcomes favoured the treatment group with no improvements observed in the placebo control group. The proportion of cocaine-positive urine samples detected in the treatment group declined from 94% to 56% compared to no change in the placebo group (79% positive). While the improvements were not significant between groups, within-group analysis revealed that the treatment group reduced self-reported cocaine use (P = 0.02), reduced criminal activity (P = 0.04), reduced cravings (P < 0.01) and reduced severity of cocaine dependence (P < 0.01) with no within-group improvements found in the placebo group.

CONCLUSIONS:

A definitive evaluation of the utility of dexamphetamine in the management of cocaine dependence is feasible and warranted.

• Authors: James Shearer, Alex Wodak, Ingrid van Beek, Richard P Mattick, John Lewis
• Journal: Addiction (Abingdon, England) (Addiction) Vol. 98 Issue 8 Pg. 1137-41 (Aug 2003) ISSN: 0965-2140 [Print] England
• PMID: 12873248 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Central Nervous System Stimulants
• Cocaine
• Dextroamphetamine

Topics

• Adult
• Central Nervous System Stimulants (adverse effects, therapeutic use)
• Cocaine (urine)
• Cocaine-Related Disorders (rehabilitation, urine)
• Dextroamphetamine (adverse effects, therapeutic use)
• Double-Blind Method
• Feasibility Studies
• Female
• Humans
• Male
• Patient Compliance
• Pilot Projects
• Treatment Outcome