Mirtazapine as a Treatment for Co-Occurring Opioid and ATS Dependence in Malaysia

• Status: Unknown status
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate tolerability, acceptability and potential efficacy of 4 months of maintenance treatment with Mirtazapine as compared to placebo for patients with co-occurring amphetamine-type stimulant and opioid dependence (COATS) receiving buprenorphine maintenance treatment (BMT) in Kota Bharu.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universiti Sains Malaysia; University of Science Malaysia
• Collaborator: Yale University
• Treatments: Amphetamine; Mianserin; Mirtazapine

Criteria

Inclusion Criteria:

1. Meet DSM-IV criteria for both opioid and ATS dependence, as assessed by the Structured Clinical Interview for DSM (SCID)

2. Active COATS dependence as documented by ATS and opioid-positive urine tests and a report of at least 2 or more days per week of ATS use during the month prior to the study enrolment.

3. Age 18-65.

Exclusion Criteria:

1. Liver enzymes greater than 3 times the upper limit of normal or evidence of liver failure or acute hepatitis

2. Having serious medical or psychiatric illnesses (including current psychotic disorder, major depression, suicidal or homicidal ideations) or taking medications to treat depression or psychosis.

3. Refused informed consent or inability to understand the protocol or assessment questions