Mechanistic Evaluation of Guanfacine on Drinking Behavior in Women and Men With Alcohol Use Disorders
Yale University
Summary
For this protocol, the investigators plan to collect pilot data to examine sex differences in guanfacine's effect on 1) counteracting stress and stimulation based drinking behavior in the laboratory and 2) improving clinical outcomes during a subsequent treatment phase.
Description
This study is a double blind, placebo controlled, parallel group design, which will compare guanfacine (6mg/day ER) to placebo (0mg/day) in treatment seeking adults meeting criteria for DSM V alcohol use disorders (160, 40 per med x sex cell). Eligibility screening consists of an intake session and a physical exam. Subjects meeting eligibility criteria will be randomized to 6mg/day ER guanfacine or matching placebo, stratified by sex. Titration to steady state medication levels will occur over a 3 week period (Weeks minus 3 to minus 1). Subjects will then complete three laboratory sessions du…
Eligibility
- Age range
- 21–70 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Age 21 70; 2. Able to read and write English; 3. Meets DSM V criteria for current (past 6 months) alcohol use disorder or Drinking criteria: Males Drinks more than 14 drinks per week and exceeds 4 drinks per day at least twice per week; Females Drinks \> more than 7 drinks per week and exceeds 3 drinks per day at least twice per week. Must meet drinking criteria during a consecutive 30 day period prior to baseline; 4. Laboratory sessions will be scheduled such that subjects will not have major responsibilities on the following day which might limit drinking during the s…
Interventions
- DrugGuanfacine ER
Guanfacine Extended Release (6mg/day ER)
- OtherPlacebo
Placebo
Location
- Yale University School of MedicineNew Haven, Connecticut