No author reports any conflict of interest.
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Double-blind placebo-controlled evaluation of the PROMETA™ protocol for methamphetamine dependence
Article first published online: 15 NOV 2011
DOI: 10.1111/j.1360-0443.2011.03619.x
© 2011 The Authors, Addiction © 2011 Society for the Study of Addiction
Additional Information
How to Cite
Ling, W., Shoptaw, S., Hillhouse, M., Bholat, M. A., Charuvastra, C., Heinzerling, K., Chim, D., Annon, J., Dowling, P. T. and Doraimani, G. (2012), Double-blind placebo-controlled evaluation of the PROMETA™ protocol for methamphetamine dependence. Addiction, 107: 361–369. doi: 10.1111/j.1360-0443.2011.03619.x
Publication History
- Issue published online: 17 JAN 2012
- Article first published online: 15 NOV 2011
- Submitted 3 March 2011; initial review completed 10 May 2011; final version accepted 12 August 2011
Corrected by:
Vol. 107, Issue 4, 860, Article first published online: 28 FEB 2012
- Abstract
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Keywords:
- Methamphetamine;
- pharmacotherapy;
- PROMETA protocol;
- substance abuse treatment
ABSTRACT
Aims To evaluate the efficacy and safety of the PROMETA™ Protocol for treating methamphetamine dependence.
Design A double-blind, placebo-controlled 108-day study with random assignment to one of two study conditions: active medication with flumazenil (2 mg infusions on days 1, 2, 3, 22, 23), gabapentin (1200 mg to day 40) and hydroxazine (50 mg to day 10) versus placebo medication (with active hydroxazine only).
Setting Three substance abuse treatment clinics: two in-patient, one out-patient.
Participants Treatment-seeking, methamphetamine-dependent adults (n = 120).
Measurements Primary outcome was percentage of urine samples testing negative for methamphetamine during the trial.
Findings No statistically significant between-group differences were detected in urine drug test results, craving, treatment retention or adverse events.
Conclusions The PROMETA protocol, consisting of flumazenil, gabapentin and hydroxyzine, appears to be no more effective than placebo in reducing methamphetamine use, retaining patients in treatment or reducing methamphetamine craving.