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

NCT01863251 | Completed Phase 2

• 1 other identifier: 1202009750
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Opiate Dependence; Stimulant Dependence

Keywords

Opiates; ATS; HIV Risks

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Retention

  4 months

• HIV Risks

  4 months

• Functional status

  4 months

Study Arms (2)

Atomoxetine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo inactive medication

Drug: Atomoxetine

Interventions

Atomoxetine DRUG

Also known as: Stratera

Atomoxetine; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Universiti Sains Malaysia

Kota Bharu, Malaysia

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Richard S Schottenfled, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

• Vicknasingam B Kasinather, Ph.D.

  Univerisiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 27, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

MY (1)