Clinical Efficacy of Atomoxetine for Methamphetamine Dependence

Phase 1

Completed

• Conditions: Methamphetamine Dependence
• Interventions: Drug: placebo; Drug: Atomoxetine

• Registration Number: NCT01557569
• Lead Sponsor: University of Arkansas

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.

Study Timeline

• Study First Submitted: 2012-03-15
• Study First Submitted QC: 2012-03-16
• Study First Posted: 2012-03-19
• Study Start: 2012-04
• Primary Completion: 2015-06
• Study Completion: 2015-07
• Results First Submitted: 2016-10-24
• Results First Submitted QC: 2016-10-24
• Status Verified: 2016-12
• Results First Posted: 2016-12-16
• Last Update Submitted: 2016-12-16
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Group will receive placebo instead of atomoxetine
Atomoxetine	Atomoxetine	Group receiving atomoxetine

Primary Outcome Measures

Name	Time	Method
Time Till Relapse	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)

Trial Locations

Locations (1)

UAMS, Psychiatric Research Institute, Center for Addiction Research; 🇺🇸 Little Rock, Arkansas, United States