Clinical Trial: Guanfacine to Reduce Relapse Risk in Women With Alcohol Use Disorder (AUD)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Guanfacine to Reduce Relapse Risk in Women With Alcohol Use Disorder (AUD)

Brief Summary: Guanfacine may preferentially reduce craving and improve cognitive control in women with Alcohol Use Disorder (AUD), compared to men. As these behaviors are related to relapse, the objectives of this study are to conduct a 10-week out-patient clinical trial to examine the effects of Guanfacine Extended Release (XR; 3mgs) versus placebo on drinking measures in women with AUD.

Detailed Summary: Gender-specific variation in sympathetic sensitivity (Fox et al., 2014; Fox and Sinha, 2009; Cahill, 2003; Heinsbroek et al., 1991) may mean that guanfacine is particularly efficacious in attenuating drinking in women, rather than men with Alcohol Use Disorder (AUD). Thus, the investigators propose a double blind, placebo-controlled, 10-week randomized clinical trial to examine the effects of Guanfacine XR (3mgs/daily) versus placebo in 60 women with AUD. This will include twice weekly appointments comprising medical management and contingency management protocols, collection of urine, breathalyzer screens, and vitals. Measures of craving and mood will also be assessed. Parallel laboratory challenge studies will also be conducted both on admission to out-patient treatment and again following 4 weeks of treatment, in order to better elucidate the potentially therapeutic mechanisms of guanfacine. Participants will be exposed to a personal stress versus relaxing imagery condition, 1 condition per day, in a randomized order. Craving, anxiety, mood, cognitive control, heart rate and blood pressure (HRBP), and biological stress system markers will be assessed at baseline, following imagery and at various recovery timepoints.
Sponsor: Stony Brook University

Current Primary Outcome: Alcohol Consumption [ Time Frame: 10 weeks ]

Ethyl glucuronide (Etg) urine toxicology screens will be collected two times per week, to assess drinking status


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Attrition rate (%) [ Time Frame: 10 weeks ]
    The percentage number of participants dropping out of the study will be calculated for both the experimental and control group
  • Alcohol Craving [ Time Frame: 10 weeks ]
    The Alcohol Urges Questionnaire (AUQ) will be administered 2 times per week to assess changes in craving. The scale comprises 8 craving-related statements ranging from 1(Strongly Disagree) to 7(Strongly Agree), yielding a total ranging from 7 to 56. The higher the score, the higher the reported craving.
  • Mood [ Time Frame: 10 weeks ]
    The Profile of Mood States (POMS) will be administered 2 times per week to assess changes in mood. The scale comprises 72 adjectives that describe different feelings, and participants are required to rate the extent to which they are experiencing each feeling at the moment, from 0= not at all; 1= a little; 2= moderately; 3= quite a bit; 4= extremely. Subscales include: Tension; Depression; Anxiety; Fatigue; Confusion; Vigor


Original Secondary Outcome: Same as current

Information By: Stony Brook University

Dates:
Date Received: April 24, 2017
Date Started: January 2017
Date Completion: December 2019
Last Updated: April 27, 2017
Last Verified: April 2017