NCT03764098

Mechanistic Evaluation of Guanfacine on Drinking Behavior in Women and Men With Alcohol Use Disorders

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed 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 during Week 0 to evaluate ad lib consumption. During each laboratory session, personalized imagery (within subject factor, stress, stimulating, or neutral/relaxing, order balanced) will precede a 2 hour alcohol self-administration period. Subjects will then begin a 6 week treatment phase (Week 1 to 6) where medication is combined with a medical management platform delivered at weekly appointments. At the end of the treatment phase, medication will be tapered for 5 days, and a final follow up evaluation will occur 1 and 3 months following the end of treatment. Primary outcome measures include the number of drinks consumed during the three self-administration sessions, and reduction in percent heavy days of drinking during treatment. Adverse events are evaluated at each study appointment and will be tabulated. The date March 1, 2019 was used as the actual start date that was associated with the preliminary funding. The study start date has been updated to reflect the beginning of the U54 grant.

Conditions

• Alcohol Use

Interventions

Type	Name	Description
DRUG	Guanfacine ER	Guanfacine Extended Release (6mg/day ER)
OTHER	Placebo	Placebo

Timeline

• Start date: 2020-08-10
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2018-12-04
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study