The Effects of Minocycline in Humans

NCT02193269 | Completed Phase 1 DMC

• 1 other identifier: 1304011871
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Memory Impairment

Keywords

Abstinent cocaine users; minocycline; antibiotic

Outcome Measures

Primary Outcomes (1)

• Rapid Visual information Processing

  Cognitive Test to determine the speed of Visual information

  2 yrs

Study Arms (2)

sugar pill

PLACEBO COMPARATOR

0.0mg

Drug: Minocycline

Minocycline

ACTIVE COMPARATOR

200mg

Drug: Sugar pill

Interventions

Sugar pill DRUG

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

Also known as: sugar pill, placebo

Minocycline

Minocycline DRUG

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

Also known as: tetracycline antibiotic

sugar pill

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Veteran Affairs Hospital

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Memory Disorders; cyclopia sequence

Interventions

Sugars; Minocycline; Tetracycline

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Mehmet Sofuoglu, M.D.,Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mehmet Sofuoglu, M.D.,Ph.D.

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 17, 2014
• Study Start: July 8, 2013
• Primary Completion: November 5, 2015
• Study Completion: November 5, 2015
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)