Atomoxetine for ATS and Opioid Dependence During Buprenorphine Maintenance Treatment in Malaysia
|ClinicalTrials.gov Identifier: NCT01863251|
Recruitment Status : Completed
First Posted : May 27, 2013
Last Update Posted : April 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Opiate Dependence Stimulant Dependence||Drug: Atomoxetine||Phase 2|
The Specific Aims of the proposed study are:
- To evaluate the tolerability, acceptability and potential effect size of the efficacy of 4 months of atomoxetine treatment for patients with co-occurring ATS and heroin dependence (COATS) receiving buprenorphine maintenance treatment (BMT) and educational drug and HIV risk reduction counseling (EDRC).
- To better characterize patients with co-occurring ATS and heroin dependence (with regard to disturbances of mood, impulse control, executive functioning and patterns of drug use during MMT) and to evaluate the effects of atomoxetine on mood, impulsivity, and executive functioning (including attention, concentration, memory, and decision-making characteristics).
- To provide training in drug abuse treatment, HIV prevention and treatment, and drug abuse clinical research to drug abuse clinical researchers and clinicians in Kota Bharu, Malaysia.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Atomoxetine for ATS and Opioid Dependence During Buprenorphine Maintenance Treatment in Malaysia|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||September 2014|
Patients assigned to atomoxetine will receive atomoxetine 40 mg daily, beginning on Day 5. Atomoxetine dose will be increased to 80 mg daily for all patients beginning on Day 12. Atomoxetine will be increased to 120 mg daily for patients with persistent ATS use after 4 weeks of treatment.
Other Name: Stratera
Placebo Comparator: Placebo
Placebo inactive medication
Other Name: Stratera
- ATS (Amphetamine-type stimulant) Use [ Time Frame: 4 months ]The primary evaluation of the effect size in the proposed study will be based on the overall proportions of urine tests negative for ATS and days per month abstinent from ATS use during the 16 week active study period.
- Retention [ Time Frame: 4 months ]treatment retention
- HIV Risks [ Time Frame: 4 months ]Reductions in HIV Risk Behaviors, as assessed by computer-assisted self-report inventory
- Functional status [ Time Frame: 4 months ]changes in functional outcomes (assessed by the ASI).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863251
|Universiti Sains Malaysia|
|Kota Bharu, Malaysia|
|Principal Investigator:||Richard S Schottenfled, M.D.||Yale University|
|Principal Investigator:||Vicknasingam B Kasinather, Ph.D.||Univerisiti Sains Malaysia|