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

May 22, 2013
June 16, 2014
May 2013
August 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01863251 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Atomoxetine for ATS and Opioid Dependence During Buprenorphine Maintenance Treatment in Malaysia
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).

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Opiate Dependence
  • Stimulant Dependence
Drug: Atomoxetine
Other Name: Stratera
  • 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.
    Intervention: Drug: Atomoxetine
  • Placebo Comparator: Placebo
    Placebo inactive medication
    Intervention: Drug: Atomoxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
August 2014
August 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Malaysia
 
NCT01863251
1202009750
No
Yale University
Yale University
Not Provided
Principal Investigator: Richard S Schottenfled, M.D. Yale University
Principal Investigator: Vicknasingam B Kasinather, Ph.D. Univerisiti Sains Malaysia
Yale University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP