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
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