CLINICAL TRIALS PROFILE FOR PROMETA
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All Clinical Trials for PROMETA
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00260481 ↗ | 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. |
| NCT00262639 ↗ | Prometa Protocol for Alcohol Dependence | Completed | Medical University of South Carolina | Phase 2/Phase 3 | 2005-12-01 | 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. |
| NCT00570388 ↗ | 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for PROMETA
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Clinical Trial Progress for PROMETA
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Clinical Trial Sponsors for PROMETA
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