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

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT01863251

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Opiate Dependence Stimulant Dependence	Drug: Atomoxetine	Phase 2

Detailed Description

The Specific Aims of the proposed study are:

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).
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).
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atomoxetine Patients assigned to atomoxetine will receive atomoxetine 40 mg daily, beginning on Day 5. Atomoxetine dose will be increased to 80 mg daily for all patients beginning on Day 12. Atomoxetine will be increased to 120 mg daily for patients with persistent ATS use after 4 weeks of treatment.	Drug: Atomoxetine Other Names: Stratera
Placebo Comparator: Placebo Placebo inactive medication	Drug: Atomoxetine Other Names: Stratera

Arm

Intervention/Treatment

Experimental: Atomoxetine

Patients assigned to atomoxetine will receive atomoxetine 40 mg daily, beginning on Day 5. Atomoxetine dose will be increased to 80 mg daily for all patients beginning on Day 12. Atomoxetine will be increased to 120 mg daily for patients with persistent ATS use after 4 weeks of treatment.

Drug: Atomoxetine

Other Names:

Stratera

Placebo Comparator: Placebo

Placebo inactive medication

Drug: Atomoxetine

Other Names:

Stratera

Outcome Measures

Primary Outcome Measures

ATS (Amphetamine-type stimulant) Use [4 months]
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.

Secondary Outcome Measures

Retention [4 months]
treatment retention
HIV Risks [4 months]
Reductions in HIV Risk Behaviors, as assessed by computer-assisted self-report inventory
Functional status [4 months]
changes in functional outcomes (assessed by the ASI).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universiti Sains Malaysia	Kota Bharu		Malaysia

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator: Richard S Schottenfled, M.D., Yale University
Principal Investigator: Vicknasingam B Kasinather, Ph.D., Univerisiti Sains Malaysia