NCT00260481

Prometa Pharmacotherapy for Methamphetamine Dependence

Double-Blind, Placebo Controlled Trial of Prometa Pharmacotherapy for the Treatment of Methamphetamine Abuse

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Using a double-blind placebo design, the effectiveness of the Prometa protocol for methamphetamine dependence will be investigated as compared to a placebo condition. The procedure utilizes a combination of medications delivered both orally and by infusion in a controlled medical setting. Participants will be randomly assigned to the active medication or placebo condition, and will receive medications for 40 days, including two inpatient hospitalization phases of three days each. All participants will also receive once-weekly psychosocial cognitive-behavioral therapy throughout the 106 day study duration. A variety of data will be collected throughout the study, including psychological, cognitive, medical, and laboratory assessments.

Conditions

• Drug Abuse
• Drug Dependence

Interventions

Type	Name	Description
DRUG	Prometa	Medication protocol includes 2 infusion periods of 3 and 2 days, respectively and outpatient medications for 39 days
DRUG	Placebo	Placebo protocol includes 2 infusion periods of 3 and 2 days, respectively and outpatient placebo medications for 39 days.

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2005-12-01
• Last updated: 2016-01-22

Locations

1 site across 1 country: United States