NCT02541526

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 4, 2015

Status Verified

September 1, 2015

Enrollment Period

3.7 years

First QC Date

June 29, 2015

Last Update Submit

September 1, 2015

Conditions

Heroin DependenceAmphetamine Dependence

Keywords

amphetamine type stimulant dependencemirtazepine

Outcome Measures

Primary Outcomes (1)

  • Reduction of illicit ATS use.

    This will be measured from baseline over time during treatment, based on urine toxicology testing and self-report

    18 weeks

Secondary Outcomes (2)

  • Reductions in sexual and HIV risk behaviour iii) Improvement of social functioning

    18 weeks

  • Improvements in neuropsychological functioning

    18 weeks

Study Arms (2)

mirtazapine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

matched placebo mirtazapine capsules will be given to patients in this group

Drug: Placebo

Interventions

MirtazapineDRUG

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

Also known as: Remeron
mirtazapine
PlaceboDRUG

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

Also known as: Sugar
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet DSM-IV criteria for both opioid and ATS dependence, as assessed by the Structured Clinical Interview for DSM (SCID)
  • 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.
  • Age 18-65.

You may not qualify if:

  • Liver enzymes greater than 3 times the upper limit of normal or evidence of liver failure or acute hepatitis
  • Having serious medical or psychiatric illnesses (including current psychotic disorder, major depression, suicidal or homicidal ideations) or taking medications to treat depression or psychosis.
  • Refused informed consent or inability to understand the protocol or assessment questions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Science Malaysia

Kota Bharu, Kelantan, 16010, Malaysia

RECRUITING

MeSH Terms

Conditions

Heroin DependenceAmphetamine-Related Disorders

Interventions

MirtazapineSugars

Condition Hierarchy (Ancestors)

Opioid-Related DisordersNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCarbohydrates

Study Officials

  • Vicknasingam Kasinather, PhD

    University Science Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vicknasingam B Kasinather, PhD

CONTACT

6046532140vickna@usm.my

Mohd Azhar Mohd Yasin, MD

CONTACT

0139826246mdazhar@usm.my

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 29, 2015

First Posted

September 4, 2015

Study Start

May 1, 2013

Primary Completion

January 1, 2017

Study Completion

May 1, 2017

Last Updated

September 4, 2015

Record last verified: 2015-09

Locations

MY(1)