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The Effects of Minocycline in Humans

Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Memory Impairment

Intervention: Sugar pill (Drug); Minocycline (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Mehmet Sofuoglu, M.D.,Ph.D., Principal Investigator, Affiliation: Yale University

Overall contact:
Lance Barnes, Phone: 203-937-4823, Email: lance.barnes@yale.edu

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.

Clinical Details

Official title: Cognitive Effects of Minocycline in Humans

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Primary outcome: Rapid Visual information Processing

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 active with recruitment continuing. (December 2014)

Eligibility

Minimum age: 21 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Lance Barnes, Phone: 203-937-4823, Email: lance.barnes@yale.edu

Veteran Affairs Hospital, West Havaen, Connecticut 06516, United States; Recruiting
Lance Barnes, Phone: 203-937-4823, Email: lance.barnes@yale.edu
Additional Information

Starting date: July 2013
Last updated: July 7, 2015

Page last updated: August 23, 2015

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