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Trial record 52 of 215 for:    TETRACYCLINE

The Effects of Minocycline in Humans

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. Identifier: NCT02193269
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : September 19, 2019
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University

Brief Summary:
To determine minocycline's effects on cognitive performance and measures of mood in abstinent cocaine users. Minocycline is a tetracycline derivative antibiotic that also inhibits microglia activation and the release of pro-inflammatory cytokines, chemokines, and nitric oxide (NO) production. Previous animal and human studies suggest that minocycline may have utility as a treatment for cocaine addiction.

Condition or disease Intervention/treatment Phase
Memory Impairment Drug: Sugar pill Drug: Minocycline Phase 1

Detailed Description:

We are proposing a randomized, double-blind, crossover study. A total of 40 male and or female subject completers will have two 4-day treatment periods, in which they will be randomized to minocycline (200 mg/day) or placebo. During the first 3 days of each treatment period, subjects will have daily clinic visits for medication administration and monitoring of adverse events. On Day 4, subjects will have an experimental session in which measures of mood and cognitive performance will be obtained. Following a washout period, ranging from 5 to 15 days, subjects will be crossed over to the alternative treatment.

This study began July 2013; currently 7 subjects were randomized with 5 completers and two drop outs. This study is in data analysis phase.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Cognitive Effects of Minocycline in Humans
Actual Study Start Date : July 8, 2013
Actual Primary Completion Date : November 5, 2015
Actual Study Completion Date : November 5, 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: sugar pill
Drug: Minocycline
you will receive 200 mg as a single daily dose for 4 days
Other Name: tetracycline antibiotic

Active Comparator: Minocycline
Drug: Sugar pill
you will receive 0.0 mg as a single daily dose for 4 days
Other Name: sugar pill, placebo

Primary Outcome Measures :
  1. Rapid Visual information Processing [ Time Frame: 2 yrs ]
    Cognitive Test to determine the speed of Visual information

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and females, between the ages of 21 and 50 who fulfill criteria for past cocaine dependence according to DSM-IV criteria;
  • No cocaine use for the past 30 days;
  • No other current dependence or abuse of other drugs of abuse or alcohol (except cocaine and tobacco);
  • No current medical problems and normal ECG;
  • For women, not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

  • current major psychiatric illnesses including mood, psychotic, or anxiety disorders;
  • history of major medical illnesses; including liver diseases, heart disease, or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study
  • Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants) or drugs that would be expected to have major interactions with drugs to be tested, e.g., benzodiazepines, codeine, percocet, and other opiate drugs that will interact with methadone.
  • Liver function tests (ALT or AST) greater than 3 times normal.
  • Allergy to minocycline or other tetracyclines.

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 identifier (NCT number): NCT02193269

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United States, Connecticut
Veteran Affairs Hospital
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
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Principal Investigator: Mehmet Sofuoglu, M.D.,Ph.D. Yale University

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Responsible Party: Mehmet Sofuoglu, Mehmet Sofuoglu, M.D.,Ph.D., Yale University Identifier: NCT02193269     History of Changes
Other Study ID Numbers: 1304011871
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mehmet Sofuoglu, Yale University:
Abstinent cocaine users
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents