Pilot randomized double blind placebo-controlled study of dexamphetamine for cocaine dependence
Article first published online: 8 SEP 2003
Volume 98, Issue 8, pages 1137–1141, August 2003
How to Cite
Shearer, J., Wodak, A., Van Beek, I., Mattick, R. P. and Lewis, J. (2003), Pilot randomized double blind placebo-controlled study of dexamphetamine for cocaine dependence. Addiction, 98: 1137–1141. doi: 10.1046/j.1360-0443.2003.00447.x
- Issue published online: 8 SEP 2003
- Article first published online: 8 SEP 2003
- Submitted 31 October 2002; initial review completed 23 December 2002; final version accepted 13 March 2003
- Cocaine dependence, dexamphetamine, randomized controlled trial, treatment.
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.