Status:
COMPLETED
Atomoxetine for ATS and Opioid Dependence During Buprenorphine Maintenance Treatment in Malaysia
Lead Sponsor:
Yale University
Conditions:
Opiate Dependence
Stimulant Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 bu...
Detailed Description
The Specific Aims of the proposed study are: 1. To evaluate the tolerability, acceptability and potential effect size of the efficacy of 4 months of atomoxetine treatment for patients with co-occurri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01863251
Start Date
May 1 2013
End Date
September 1 2014
Last Update
April 27 2017
Active Locations (1)
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1
Universiti Sains Malaysia
Kota Bharu, Malaysia