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

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ClinicalTrials.gov Identifier: NCT02541526
Recruitment Status : Unknown
Verified September 2015 by Vicknasingam B Kasinather, University of Science Malaysia.
Recruitment status was:  Recruiting
First Posted : September 4, 2015
Last Update Posted : September 4, 2015
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Vicknasingam B Kasinather, University of Science Malaysia

Brief 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.

Condition or disease Intervention/treatment Phase
Heroin Dependence Amphetamine Dependence Drug: Mirtazapine Drug: Placebo Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Mirtazapine as a Treatment for Co-Occurring Opioid and Amphetamine Type Stimulant Dependence (COATS) in Malaysia
Study Start Date : May 2013
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mirtazapine
30 mg mirtazepine will be given to patients on day 6 of their treatment for a period pf 3 days to observe for tolerability followed by 60 mg from day 9 of treatment until the end of the study (16 weeks).
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
Other Name: Remeron

Placebo Comparator: Placebo
matched placebo mirtazapine capsules will be given to patients in this group
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
Other Name: Sugar




Primary Outcome Measures :
  1. Reduction of illicit ATS use. [ Time Frame: 18 weeks ]
    This will be measured from baseline over time during treatment, based on urine toxicology testing and self-report


Secondary Outcome Measures :
  1. Reductions in sexual and HIV risk behaviour iii) Improvement of social functioning [ Time Frame: 18 weeks ]
    Measured by repeated assessments of sexual and HIV risk behaviours

  2. Improvements in neuropsychological functioning [ Time Frame: 18 weeks ]
    Measured by repeated assessments of neuropsychological functioning



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541526


Contacts
Contact: Vicknasingam B Kasinather, PhD 6046532140 ext 2140 vickna@usm.my
Contact: Mohd Azhar Mohd Yasin, MD 0139826246 mdazhar@usm.my

Locations
Malaysia
University Science Malaysia Recruiting
Kota bharu, Kelantan, Malaysia, 16010
Contact: Vicknasingam B Kasinather, PhD    6046532140    vickna@usm.my   
Contact: Imran Ahmad    6097676603    profimran@usm.my   
Sponsors and Collaborators
University of Science Malaysia
Yale University
Investigators
Principal Investigator: Vicknasingam Kasinather, PhD University Science Malaysia

Responsible Party: Vicknasingam B Kasinather, Dr, University of Science Malaysia
ClinicalTrials.gov Identifier: NCT02541526     History of Changes
Other Study ID Numbers: 00004494b
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: September 4, 2015
Last Verified: September 2015

Keywords provided by Vicknasingam B Kasinather, University of Science Malaysia:
amphetamine type stimulant dependence
mirtazepine

Additional relevant MeSH terms:
Heroin Dependence
Amphetamine-Related Disorders
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Amphetamine
Mirtazapine
Mianserin
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents