Clinical trial NCT01863251: Atomoxetine for ATS and Opioid Dependence During Buprenorphine Maintenance Treatment in Malaysia
Official title: Atomoxetine for ATS and Opioid Dependence During Buprenorphine Maintenance Treatment in Malaysia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opiate Dependence
Stimulant Dependence
Keywords: Opiates
ATS
HIV Risks
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2013-05-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 buprenorphine maintenance treatment (BMT) and educational drug and HIV risk reduction counseling (EDRC).

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 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.

Primary outcomes:
measure: ATS (Amphetamine-type stimulant) Use
timeFrame: 4 months
Secondary outcomes:
measure: Retention
timeFrame: 4 months
measure: HIV Risks
timeFrame: 4 months
measure: Functional status
timeFrame: 4 months
Other outcomes:
Locations:
city: Kota Bharu
country: Malaysia
facility: Universiti Sains Malaysia
Study officials:
affiliation: Yale University
name: Richard S Schottenfled, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Univerisiti Sains Malaysia
name: Vicknasingam B Kasinather, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: