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

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).

Study Overview

• Status: Completed
• Conditions: Opiate Dependence; Stimulant Dependence
• Intervention / Treatment: Drug: Atomoxetine

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Malaysia
  • Kota Bharu, Malaysia
    • Universiti Sains Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: May 22, 2013
• First Submitted That Met QC Criteria: May 24, 2013
• First Posted (ESTIMATE): May 27, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Opiates; ATS; HIV Risks
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Adrenergic Uptake Inhibitors; Atomoxetine Hydrochloride
• Other Study ID Numbers: 1202009750

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No