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Clinical Efficacy of Atomoxetine for Methamphetamine Dependence — ATM  

Methamphetamine Dependence Clinical Trial

Clinical Trial Summary

The purpose of this study is to examine the ability of atomoxetine compared to placebo to increase time to relapse in methamphetamine dependent volunteers. The investigators will also examine the effectiveness of atomoxetine compared to placebo to relieve withdrawal symptoms in methamphetamine dependent participants over a 10-week time period. Our hypothesis is that atomoxetine will improve withdrawal symptoms compared to placebo in methamphetamine dependent participants and that this effect will be associated with an increase in time before (if) the participant relapses.

Clinical Trial Description

During the study participants will spend the initial 2-weeks of the study at an inpatient facility. This will help participants initiate withdrawal. During the following 8-weeks the participant will come in for 3-4 visits each week. Three of these visits will be with the research assistants and one visit will be with a therapist in order to work with the participant using a cognitive behavioral therapy approach. Therapy visits are typically scheduled on a day that the participant is coming for clinic anyways so the number of visits per week is typically 3. During the 10-week period the investigators will collect vitals, cognitive assessments, mood assessments, ratings of feelings of withdrawal, urine drug screens, weekly use reports of methamphetamine, and any reports of symptoms or side effects. This will tell the investigators if atomoxetine helps relieve methamphetamine withdrawal symptoms and will tell us if a participant lapsed or relapsed. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01557569
Study type Interventional
Source University of Arkansas
Contact
Status Completed
Phase Phase 1/Phase 2
Start date April 2012
Completion date July 2015
View Details
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