CClinicalTrials.gg
Sign In
CompletedNCT01863251Updated Apr 27, 2017

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

A Phase 2 interventional study of Atomoxetine in Opiate Dependence and Stimulant Dependence, sponsored by Yale University. Completed at 1 site in Malaysia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-04-27.

Sponsored by Yale University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

Read the 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.
02

Conditions studied

  • Opiate Dependence
  • Stimulant Dependence

Keywords

  • Opiates
  • ATS
  • HIV Risks
03

In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 90 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Placebo

    Placebo inactive medication

    Drug: Atomoxetine

Interventions

  • DrugAtomoxetine

    Also known as: Stratera

06

What researchers measure

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.

    Time frame: 4 months

Secondary outcomes

  1. Retention

    treatment retention

    Time frame: 4 months

  2. HIV Risks

    Reductions in HIV Risk Behaviors, as assessed by computer-assisted self-report inventory

    Time frame: 4 months

  3. Functional status

    changes in functional outcomes (assessed by the ASI).

    Time frame: 4 months

07

Study locations

1 site
  • Universiti Sains Malaysia
    Kota Bharu, Malaysia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01863251
Lead sponsor
Yale University
Responsible party
Sponsor
First posted
May 27, 2013
Start date
May 2013
Primary completion
Aug 2014
Completion
Sep 2014
Last update
Apr 27, 2017

Study contacts

Richard S Schottenfled, M.D.
principal investigator · Yale University
Vicknasingam B Kasinather, Ph.D.
principal investigator · Univerisiti Sains Malaysia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Opioid-Related Disorders→

Other studies from this sponsor

Yale University

Start the discussion