Double-blind placebo-controlled evaluation of the PROMETA™ protocol for methamphetamine dependence.

To evaluate the efficacy and safety of the PROMETA™ Protocol for treating methamphetamine dependence. 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). Three substance abuse treatment clinics: two in-patient, one out-patient. Treatment-seeking, methamphetamine-dependent adults (n = 120). Primary outcome was percentage of urine samples testing negative for methamphetamine during the trial. No statistically significant between-group differences were detected in urine drug test results, craving, treatment retention or adverse events. 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.