MedTrace Logo

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

NCT02541526 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-09-04

No results posted yet for this study

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.

Conditions

  • Heroin Dependence
  • Amphetamine Dependence

Interventions

DRUG

Mirtazapine

One capsule (15 mg) oral mirtazepine daily will be started on day six of treatment for a period of 3 days followed by two capsules (30 mg) daily for a period of four months

DRUG

Placebo

Similar capsule containing placebo will be started on day six of treatment for a period of 3 days followed by two capsules of placebo daily for a period of four months

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • Universiti Sains Malaysia

    lead OTHER

Principal Investigators

  • Vicknasingam Kasinather, PhD · University Science Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2017-01-31
Completion
2017-05-31

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02541526 on ClinicalTrials.gov