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

Stony Brook University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Alcohol Abstinence

Treatments: Drug: Guanfacine XR 3mgs/daily; Drug: Placebo (for guanfacine)

Study type: Interventional

Funder types: Other

Identifiers

NCT03137082

R21AA024880

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must meet Diagnostic and Statistical Manual of Mental Disorders-V (DSM- V) criteria for moderate to severe Alcohol Use Disorder (AUD),
• Must produce positive urine toxicology screens on admission to study
• Must demonstrate good health as verified by screening examination
• Must be able to read English and complete study evaluations
• Must be able to provide informed written and verbal consent

Exclusion criteria

• Meeting current use disorder for any other psychoactive substance, excluding nicotine.
• Having any other current Axis I psychiatric disorders or medical conditions requiring treatment or medication
• EKG evidence at baseline screening of any clinically significant conduction abnormalities including a Bazlett's QTc (corrected QT interval) of >470 msec.
• Must not be on monophasic contraceptives, nursing or pregnant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 2 patient groups, including a placebo group

Guanfacine XR 3mgs/daily

Experimental group

Description:

* Guanfacine XR tablet by mouth every 24 hours for 12 weeks * 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21) * Full dose: 3mgs/d (day 21- day 70) * 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)

Treatment:

Drug: Guanfacine XR 3mgs/daily

Placebo (for guanfacine)

Placebo Comparator group

Description:

* Guanfacine XR tablet by mouth every 24 hours for 12 weeks * 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21) * Full dose: 3mgs/d (day 21- day 70) * 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)

Treatment:

Drug: Placebo (for guanfacine)