Atomoxetine for ATS and Opioid Dependence During Buprenorphine Maintenance Treatment in Malaysia

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Atomoxetine Hydrochloride; Buprenorphine

Criteria

Inclusion Criteria:

• Meet Opioid and Amphetamine-type stimulant (ATS)dependence, as assessed by the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM-IV) (SCID) and documented by opioid-positive and ATS positive urine tests.

• Report at least 2 or more days per week of ATS use over the past month.

Exclusion Criteria:

• Hypersensitivity to atomoxetine;

• Current use of a monoamine oxidase inhibitor (MAOI) or use within the preceding 2 weeks;

• Suffer from narrow angle glaucoma; pheochromocytoma; severe cardiovascular disorder; liver enzymes greater than 3 times the upper limit of normal; liver failure or acute hepatitis;

• Pregnancy or breast feeding;

• Current suicide or homicide risk;

• Current psychotic disorder or major depression;

• Inability to understand the protocol or assessment questions.

• A physician reviews the results of all baseline assessments and laboratory and other medical tests (CBC, chemistries, liver enzymes, HIV and Hepatitis B and C, EKG, chest x-ray), takes a medical history, and performs a physical examination in order to confirm the patient's eligibility for the study.