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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01863251
First received: May 22, 2013
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Opiate Dependence
Stimulant Dependence
Drug: Atomoxetine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Atomoxetine for ATS and Opioid Dependence During Buprenorphine Maintenance Treatment in Malaysia

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • ATS (Amphetamine-type stimulant) Use [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    treatment retention

  • HIV Risks [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Reductions in HIV Risk Behaviors, as assessed by computer-assisted self-report inventory

  • Functional status [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    changes in functional outcomes (assessed by the ASI).


Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Stratera
Placebo Comparator: Placebo
Placebo inactive medication
Drug: Atomoxetine
Other Name: Stratera

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01863251

Locations
Malaysia
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
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01863251     History of Changes
Other Study ID Numbers: 1202009750
Study First Received: May 22, 2013
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Opiates
ATS
HIV Risks

Additional relevant MeSH terms:
Buprenorphine
Atomoxetine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014