Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Terminated NCT01813656 - An Study of Aripiprazole in the Treatment of Methamphetamine Dependence Phase 4
Completed NCT00984360 - Study of Naltrexone for Methamphetamine Addiction Phase 2
Completed NCT01685463 - Transcranial Magnetic Stimulation Used to Both Measure Cortical Excitability and Explore Methamphetamine Cue Craving N/A
Completed NCT00569374 - Safety and Tolerability of Modafinil for Methamphetamine Dependence Phase 2
Completed NCT01967381 - Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse Early Phase 1
Completed NCT01354470 - A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence Phase 2
Active, not recruiting NCT01044238 - Methylphenidate to Treat Methamphetamine Dependence Phase 2
Completed NCT01215929 - Studying Amphetamine Withdrawal in Humans Phase 2
Terminated NCT01019707 - Safety Assessment of Atomoxetine With MA IV Administration Phase 1
Completed NCT00227123 - A Randomized Control Trial Comparing Quetiapine to Risperidone in Bipolar Disorder With Stimulant Dependence N/A
Recruiting NCT02568878 - Creatine for Depressed Male and Female Methamphetamine Users Phase 3
Completed NCT01011829 - Varenicline vs Placebo for the Treatment of Methamphetamine Dependence Phase 2
Completed NCT01007539 - Efficacy and Safety of CDP-choline in Patients With Methamphetamine Dependence Phase 3
Completed NCT01062451 - An ACE Inhibitor (Perindopril) or an Angiotensin Receptor Blocker (Candesartan) as a Treatment for Methamphetamine Dependence Phase 1
Completed NCT00687713 - Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence Phase 2
Completed NCT01063205 - NAC as a Potential Treatment for Methamphetamine Dependence Phase 1
Completed NCT02058966 - Pilot Study of Entacapone for Methamphetamine Abuse Early Phase 1
Completed NCT00332605 - N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence Phase 2
Completed NCT01860807 - Trial of Ibudilast for Methamphetamine Dependence Phase 2
Terminated NCT01813643 - A Comparison of Risperidone and Aripiprazole for Treatment of Patirnts With Methamphetamine-Associated Psychosis Phase 4