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


METHODS
Double-blind randomized placebo-controlled trial.


METHODS
Thirty cocaine-dependent injecting drug users.


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


METHODS
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.


RESULTS
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.
Shearer
James
J
National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia. j.shearer@unsw.edu.au
Wodak
Alex
A
van Beek
Ingrid
I
Mattick
Richard P
RP
Lewis
John
J
D000328:Adult; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D003042:Cocaine / Q000652:urine; D019970:Cocaine-Related Disorders / Q000534:rehabilitation* / Q000652:urine; D003913:Dextroamphetamine / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D010349:Patient Compliance; D010865:Pilot Projects; D016896:Treatment Outcome
D000697:Central Nervous System Stimulants; D003042:Cocaine; D003913:Dextroamphetamine