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An Open Label Study of Oral Minocycline for the Treatment of Patients With Co-occurring Opioid and ATS Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02541500
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 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study of Oral Minocycline for the Treatment of Patients With Co-occurring Opioid and Amphetamine-type Stimulant Dependence (COATS)
Study Start Date : April 2013
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Minocycline
Patients in this arm will receive oral minocycline
Drug: Minocycline
Oral minocycline 200 mg daily will be started on day six of treatment for a period of four months
Other Name: Borymycin




Primary Outcome Measures :
  1. Reduction in 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 drug-related HIV risk behaviors [ Time Frame: 18 weeks ]
    Measured by repeated assessments of sexual and HIV risk behaviors during treatment

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



Information from the National Library of Medicine

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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. 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.
  3. Age 18 - 65 years old

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): NCT02541500


Contacts
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Contact: Vicknasingam B Kasinather, PhD 6046532140 ext 2140 vickna@usm.my

Locations
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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
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Principal Investigator: Imran Ahmad, MBBS University Science Malaysia

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Responsible Party: Vicknasingam B Kasinather, Dr, University of Science Malaysia
ClinicalTrials.gov Identifier: NCT02541500    
Other Study ID Numbers: 00004494
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:
minocycline
amphetamine type stimulant dependence
Additional relevant MeSH terms:
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Heroin Dependence
Amphetamine-Related Disorders
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Minocycline
Amphetamine
Anti-Bacterial Agents
Anti-Infective Agents
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