Prometa Pharmacotherapy for Methamphetamine Dependence
Completed
University of California, Los Angeles
Phase 2/Phase 3
2006-01-01
The purpose of this study is to assess the efficacy of the PROMETA pharmacotherapy compared
to placebo for initiating abstinence and for preventing relapse to methamphetamine use in
treatment-seeking individuals meeting criteria for methamphetamine abuse. It is hypothesized
that individuals assigned to receive the PROMETA pharmacotherapy, compared to placebo, will
demonstrate significantly fewer and less intense withdrawal symptoms, more days abstinent
from methamphetamine use, and fewer relapses to methamphetamine use as assessed by
self-report of drug use verified by urine samples.
This is a placebo controlled trial (some people receive active and some people receive
inactive medication) to evaluate the effectiveness of a new protocol to treat alcohol
dependence. Two main medications (plus ancillary non-placebo controlled medications) and
their placebos (inactive drugs) will be utilized to treat both alcohol withdrawal, promote
abstinence, and reduce drinking over approximately a six-week treatment period. All
participants will meet criteria for Alcohol Dependence and be drinking heavily up until 72
hours prior to receiving the first study drug. They will be injected one drug (flumazenil or
placebo) over a two day period and receive the second one (gabapentin or placebo) by mouth
for 39 days. The main hypothesis is that this protocol will reduce early alcohol withdrawal
symptoms and will reduce relapse to drinking and promote abstinence compared to the placebo
(inactive) drug group. Secondary outcomes that will be evaluated include reduction in
craving, improvement in sleep, brain activity and mood.
Neurocognitive Functioning Following The PROMETA® Treatment Protocol In Subjects With Alcohol Dependence
Unknown status
Institute of Addiction Medicine
N/A
2007-03-01
This study will test the safety and efficacy of the PROMETA® Treatment Protocol (which
includes the benzodiazepine antagonist flumazenil) in reversing the neurocognitive impairment
and this in turn will lead to improved ability to resist alcohol related cues and enhance
involvement in psychosocial treatment.
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