Clinical Efficacy of Atomoxetine for Methamphetamine Dependence
Overview
- Phase
- Phase 1
- Intervention
- placebo
- Conditions
- Methamphetamine Dependence
- Sponsor
- University of Arkansas
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Time Till Relapse
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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. Our hypothesis is that atomoxetine will increase time before (if) the participant relapses.
Detailed 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 various measures, including vitals, cognitive assessments, mood assessments, urine drug screens, weekly use reports of methamphetamine, and any reports of symptoms or side effects. This will tell the investigators if atomoxetine is safe and if a participant lapsed or relapsed.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Group will receive placebo instead of atomoxetine
Intervention: placebo
Atomoxetine
Group receiving atomoxetine
Intervention: Atomoxetine
Outcomes
Primary Outcomes
Time Till Relapse
Time Frame: 57 days
The number of days until a participant has a relapse, which will be measured by qualitative urine drug screens. To ensure a large enough sample, those who drop out prior to completing the residential stay will be included in this analysis (with minus days until relapse)