Minocycline's Effects on Alcohol Responses in Humans
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 50 |
| Updated: | 9/7/2018 |
| Start Date: | July 2015 |
| End Date: | November 2018 |
| Contact: | Elizabeth Ralevski, Ph.D. |
| Email: | elizabeth.ralevski@yale.edu |
| Phone: | (203) 932-5711 |
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.
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.
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.
We found this trial at
1
site
950 Campbell Ave
West Haven, Connecticut 06516
West Haven, Connecticut 06516
(203) 932-5711
Phone: 203-932-5711
VA Connecticut Healthcare System VA Connecticut encompasses an inpatient facility and Ambulatory Care Center in...
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