Mechanistic Evaluation of Guanfacine on Drinking Behavior
- Study HIC#:2000023970
- Last Updated:07/15/2021
In this study, we are seeking individuals who are interested in reducing or cutting back their drinking behavior. We will be looking at how the medication Intuniv, which is Guanfacine, influences drinking behavior. Guanfacine is a medication that has been approved by the Food and Drug Administration (FDA) to treat high blood pressure and ADHD. There are three phases to the study.
- Age21 years - 70 years
- Start Date03/01/2019
- End Date09/29/2026
Trial Purpose and Description
This study is a proof-of-concept Phase 2b double-blind, placebo-controlled, parallel-group design, which will compare guanfacine (6mg/day ER) to placebo in treatment-seeking adults meeting criteria for DSM-5 AUD (n=32, 8 per med x sex cell). This study will consist of an intake session, a physical exam, script development, and three laboratory sessions following medication titration to steady-state levels. 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. Participants will then begin a 6-week treatment phase where medication is combined with a medical management platform. At the end of the treatment phase, medication will be tapered, 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 self-administration sessions and % reduction in heavy days of drinking during treatment.
Drinks alcohol often.
Interested in changing their drinking.
Other criteria will be assessed by phone or in-person.