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

Primary Purpose

Opiate Dependence, Stimulant Dependence

Status
Completed
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Atomoxetine
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Dependence focused on measuring Opiates, ATS, HIV Risks

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Universiti Sains Malaysia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atomoxetine

Placebo

Arm Description

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.

Placebo inactive medication

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 22, 2013
Last Updated
April 25, 2017
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT01863251
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

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
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence, Stimulant Dependence
Keywords
Opiates, ATS, HIV Risks

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atomoxetine
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo inactive medication
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Other Intervention Name(s)
Stratera
Primary Outcome Measure Information:
Title
ATS (Amphetamine-type stimulant) Use
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Retention
Description
treatment retention
Time Frame
4 months
Title
HIV Risks
Description
Reductions in HIV Risk Behaviors, as assessed by computer-assisted self-report inventory
Time Frame
4 months
Title
Functional status
Description
changes in functional outcomes (assessed by the ASI).
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard S Schottenfled, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vicknasingam B Kasinather, Ph.D.
Organizational Affiliation
Univerisiti Sains Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universiti Sains Malaysia
City
Kota Bharu
Country
Malaysia

12. IPD Sharing Statement

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

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