Opiate Dependence Clinical Trial
Official title:
Atomoxetine for ATS and Opioid Dependence During Buprenorphine Maintenance Treatment in Malaysia
Verified date | April 2017 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 90 |
Est. completion date | September 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Malaysia | Universiti Sains Malaysia | Kota Bharu |
Lead Sponsor | Collaborator |
---|---|
Yale University |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ATS (Amphetamine-type stimulant) Use | 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. | 4 months | |
Secondary | Retention | treatment retention | 4 months | |
Secondary | HIV Risks | Reductions in HIV Risk Behaviors, as assessed by computer-assisted self-report inventory | 4 months | |
Secondary | Functional status | changes in functional outcomes (assessed by the ASI). | 4 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
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