Atomoxetine for ATS and Opioid Dependence During Buprenorphine Maintenance Treatment in Malaysia
Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opiate Dependence; Stimulant Dependence
Intervention: Atomoxetine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Yale University Official(s) and/or principal investigator(s): Richard S Schottenfled, M.D., Principal Investigator, Affiliation: Yale University Vicknasingam B Kasinather, Ph.D., Principal Investigator, Affiliation: Univerisiti Sains Malaysia
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).
Clinical Details
Official title: Atomoxetine for ATS and Opioid Dependence During Buprenorphine Maintenance Treatment in Malaysia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: ATS (Amphetamine-type stimulant) Use
Secondary outcome: RetentionHIV Risks Functional status
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-occurring ATS and heroin
dependence (COATS) receiving buprenorphine maintenance treatment (BMT) and educational
drug and HIV risk reduction counseling (EDRC).
2. 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).
3. 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Universiti Sains Malaysia, Kota Bharu, Malaysia
Additional Information
Starting date: May 2013
Last updated: January 21, 2015
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