The Effects of Minocycline in Humans

NCT ID: NCT02193269

Last Updated: 2019-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-08
• Study Completion Date: 2015-11-05

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.

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.

Conditions

Memory Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

sugar pill

0.0mg

Group Type: PLACEBO_COMPARATOR

Minocycline

Intervention Type: DRUG

you will receive 200 mg as a single daily dose for 4 days

Minocycline

200mg

Group Type: ACTIVE_COMPARATOR

Sugar pill

Intervention Type: DRUG

you will receive 0.0 mg as a single daily dose for 4 days

Interventions

Sugar pill

you will receive 0.0 mg as a single daily dose for 4 days

Intervention Type: DRUG

Minocycline

you will receive 200 mg as a single daily dose for 4 days

Intervention Type: DRUG

Other Intervention Names

sugar pill, placebo; tetracycline antibiotic

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Sofuoglu

Mehmet Sofuoglu, M.D.,Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet Sofuoglu, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Veteran Affairs Hospital

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

1304011871

Identifier Type: -

Identifier Source: org_study_id