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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT03764098
Phase
PHASE2
Status
Recruiting
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Conditions

  • Alcohol Use

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Guanfacine ER — DRUG
    Guanfacine Extended Release (6mg/day ER)
  • Placebo — OTHER
    Placebo

Study Details

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.

Key Dates

Start date
Aug 10, 2020
Status verified
Feb 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Guanfacine ER
    Guanfacine extended release (6mg/day ER). Administered orally twice daily at 8:00 AM and 8:00 PM while titrating to the full dose. Titration schedule: Days 1-3 1mg/day; 0.5mg/dose, Days 4-6 2mg/day; 1mg/dose, Days 7-9 3mg/day; 1.5mg/dose, Days 10-12 4mg/day; 2mg/dose; Days 13-15 5mg/day; 2.5mg/dose and Days 16-23 6mg/day; 3mg/dose. Once at steady state, administration is orally once per day at 8:00 PM.
  • Placebo Comparator: Placebo
    Administered orally twice a day at 8:00 AM and 8:00 PM Days 1-23, then orally once a day at 8:00 PM.

Primary Outcome Measure

Alcohol Consumption [ Time Frame: 120 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale University School of MedicineNew HavenConnecticut06510
Meaghan Lavery
[email protected]
203-737-2783
Sabrina Coppola
[email protected]
203-737-2827
Sherry McKee, PhD (PRINCIPAL_INVESTIGATOR)

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