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Minocycline's Effects on Alcohol Responses in Humans

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ClinicalTrials.gov Identifier: NCT02187211
Recruitment Status : Recruiting
First Posted : July 10, 2014
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Yale University

Brief Summary:
This is a double-blind, placebo-controlled, outpatient study with a between-groups design. Sixty male and female heavy social drinkers will be randomly assigned to minocycline (200 or 400 mg/day) or placebo for 10 days. In the first 7 days of treatment, subjects will have 3 outpatient visits for medication administration, dispensing of take-home doses and monitoring of any adverse effects from study medications. On days 8 and 10 of treatment, subjects will have 2 laboratory sessions where alcohol or placebo will be administered intravenously using a clamp procedure. Alcohol administration will use a breath alcohol concentration (BrAc) method, targeting 100 mg %. The alcohol clamp procedure will allow collection of multiple outcome measures including subjective, motor, cognitive measurement and plasma cytokine levels.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Minocycline Drug: Placebo (for Minocycline) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Minocycline's Effects on Alcohol Responses in Humans
Study Start Date : July 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Minocycline Low Dose
Participants in this arm will receive a low dose (200mg/day) of Minocycline for 10 days
Drug: Minocycline
Experimental: Minocycline High Dose
Participants in this arm will receive a high dose (400mg/day) of Minocycline for 10 days
Drug: Minocycline
Placebo Comparator: Placebo
Participants in this arm will receive the Placebo for 10 days
Drug: Placebo (for Minocycline)



Primary Outcome Measures :
  1. Biphasic Alcohol Effects Scale (BAES) [ Time Frame: Days 1-10 ]
    BAES will be used to measure the stimulant and sedative effects of alcohol during the test sessions. This instrument has been found to be a sensitive and reliable measure to study medication influences on alcohol effects



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

Inclusion Criteria:

  1. Male and females, between the ages of 21 and 50;
  2. Heavy social drinkers who are defined as consuming ≥10 standard alcoholic drinks per week with one to five weekly "binge" drinking episodes, (5 plus drinks per occasion for men; 4 plus drinks for women). No maximum level of alcohol consumption will be defined a priori but individuals who met current DSM -IV criteria for AUD will be excluded from the study;
  3. No current drug use disorder of any drugs of abuse (except alcohol and tobacco);
  4. No current medical problems and normal ECG; 5) For women, not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

  1. Current major psychiatric illnesses including mood, psychotic, or anxiety disorders;
  2. History of major medical illnesses; including liver diseases, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study;
  3. Liver function tests (ALT or AST) greater than 3 times normal;
  4. Allergy to minocycline or other tetracyclines;
  5. Participants who at any appointment have a Clinical Institute Withdrawal Assessment Scale (CIWA) [36, 37] score of 4 or greater, or who report any history of alcohol withdrawal within the past 6 months.

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 ClinicalTrials.gov identifier (NCT number): NCT02187211


Contacts
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Contact: Elizabeth Ralevski, Ph.D. (203) 932-5711 ext 4282 elizabeth.ralevski@yale.edu
Contact: Diana Limoncelli, B.A. (203) 932-5711 ext 5217 diana.limoncelli@yale.edu

Locations
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United States, Connecticut
VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Elizabeth Ralevski, Ph.D.    203-932-5711 ext 4282    elizabeth.ralevski@yale.edu   
Sponsors and Collaborators
Yale University
United States Department of Defense
Investigators
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Principal Investigator: Ismene Petrakis, M.D. Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02187211     History of Changes
Other Study ID Numbers: 1312013129
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

Keywords provided by Yale University:
Alcohol Dependence
Minocycline

Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Minocycline
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Bacterial Agents