Clinical Efficacy of Atomoxetine for Methamphetamine Dependence (ATM)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
- Time till relapse [ Time Frame: 56 days ] [ Designated as safety issue: No ]The number of days until a participant has a relapse, which will be measure by qualitative urine drug screens.
|Study Start Date:||April 2012|
|Study Completion Date:||July 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Atomoxetine
Group receiving atomoxetine
During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)
Other Name: strattera
Placebo Comparator: Placebo
Group will receive placebo instead of atomoxetine
participants in this group will receive 1 dose of placebo daily for the entire 10-weeks.
Other Name: "sugar pill"
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557569
|United States, Arkansas|
|UAMS, Psychiatric Research Institute, Center for Addiction Research|
|Little Rock, Arkansas, United States, 72034|
|Principal Investigator:||Alison Oliveto, PhD||University of Arkansas|