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

Opiate Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01863251
• Other study ID #: 1202009750
• Status: Completed
• Phase: Phase 2
• First received: May 22, 2013
• Last updated: April 25, 2017
• Start date: May 2013
• Est. completion date: September 2014

Study information

• Verified date: April 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Opiate Dependence
• Opioid-Related Disorders
• Stimulant Dependence

Intervention

Drug:
• Atomoxetine

Locations

Country	Name	City	State
Malaysia	Universiti Sains Malaysia	Kota Bharu

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

Malaysia, 

Outcome

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