NCT02187211

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

3.3 years

First QC Date

July 8, 2014

Last Update Submit

March 4, 2020

Conditions

Alcohol Dependence

Keywords

Alcohol DependenceMinocycline

Outcome Measures

Primary Outcomes (1)

  • Biphasic Alcohol Effects Scale (BAES)

    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

    Days 1-10

Study Arms (3)

Minocycline Low Dose

EXPERIMENTAL

Participants in this arm will receive a low dose (200mg/day) of Minocycline for 10 days

Drug: Minocycline

Minocycline High Dose

EXPERIMENTAL

Participants in this arm will receive a high dose (400mg/day) of Minocycline for 10 days

Drug: Minocycline

Placebo

PLACEBO COMPARATOR

Participants in this arm will receive the Placebo for 10 days

Drug: Placebo (for Minocycline)

Interventions

MinocyclineDRUG
Minocycline High DoseMinocycline Low Dose
Placebo (for Minocycline)DRUG
Placebo

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and females, between the ages of 21 and 50;
  • 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;
  • No current drug use disorder of any drugs of abuse (except alcohol and tobacco);
  • 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.

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, chronic pain or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study;
  • Liver function tests (ALT or AST) greater than 3 times normal;
  • Allergy to minocycline or other tetracyclines;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Alcoholismcyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Ismene Petrakis, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2014

First Posted

July 10, 2014

Study Start

July 1, 2015

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

March 9, 2020

Record last verified: 2020-03

Locations

US(1)