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Minocycline's Effects on Alcohol Responses in Humans

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ClinicalTrials.gov Identifier: NCT02187211
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE July 8, 2014
First Posted Date  ICMJE July 10, 2014
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE July 1, 2015
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02187211 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Minocycline's Effects on Alcohol Responses in Humans
Official Title  ICMJE Minocycline's Effects on Alcohol Responses in Humans
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Dependence
Intervention  ICMJE
  • Drug: Minocycline
  • Drug: Placebo (for Minocycline)
Study Arms  ICMJE
  • Experimental: Minocycline Low Dose
    Participants in this arm will receive a low dose (200mg/day) of Minocycline for 10 days
    Intervention: Drug: Minocycline
  • Experimental: Minocycline High Dose
    Participants in this arm will receive a high dose (400mg/day) of Minocycline for 10 days
    Intervention: Drug: Minocycline
  • Placebo Comparator: Placebo
    Participants in this arm will receive the Placebo for 10 days
    Intervention: Drug: Placebo (for Minocycline)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2019)
54
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2014)
60
Actual Study Completion Date  ICMJE November 1, 2018
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02187211
Other Study ID Numbers  ICMJE 1312013129
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Ismene Petrakis, M.D. Yale University
PRS Account Yale University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP