NCT02541500

Brief Summary

The proposed study will evaluate the tolerability, acceptability and potential efficacy of minocycline for the treatment of co-occurring opioid and amphetamine-type stimulant (ATS) dependence. In the proposed clinical trial, all patients will first discontinue illicit opioid and ATS and be inducted onto buprenorphine maintenance treatment (BMT) in the inpatient ward at the department of psychiatry before beginning to receive minocycline. Tolerability and acceptability will be evaluated by assessing the rates of patient retention during treatment, patient satisfaction with treatment and adverse effects during treatment. The potential efficacy of minocycline will be evaluated with regard to the primary outcome measure: reductions in ATS use , based on urine toxicology testing and self-report. Secondary outcome measures include retention, reduction in HIV risk behaviors and improvements in functional status.

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
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 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

April 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
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

September 4, 2015

Status Verified

September 1, 2015

Enrollment Period

3.8 years

First QC Date

June 29, 2015

Last Update Submit

September 1, 2015

Conditions

Heroin DependenceAmphetamine Dependence

Keywords

minocyclineamphetamine type stimulant dependence

Outcome Measures

Primary Outcomes (1)

  • Reduction in 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 drug-related HIV risk behaviors

    18 weeks

  • Measure improvements in neuropsychological functioning

    18 weeks

Study Arms (1)

Minocycline

EXPERIMENTAL

Patients in this arm will receive oral minocycline

Drug: Minocycline

Interventions

MinocyclineDRUG

Oral minocycline 200 mg daily will be started on day six of treatment for a period of four months

Also known as: Borymycin
Minocycline

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)
  • ActiveCOATS 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 over the past month.
  • Age 18 - 65 years old

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 Disorderscyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Imran Ahmad, MBBS

    University Science Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vicknasingam B Kasinather, PhD

CONTACT

6046532140vickna@usm.my

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
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

April 1, 2013

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

September 4, 2015

Record last verified: 2015-09

Locations

MY(1)