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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-12

Study Completion Date

2021-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alcohol Abstinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Guanfacine XR 3mgs/daily

* 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)

Group Type EXPERIMENTAL

Guanfacine XR 3mgs/daily

Intervention Type DRUG

Guanfacine 3mg tablet

Placebo (for guanfacine)

* 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)

Group Type PLACEBO_COMPARATOR

Placebo (for guanfacine)

Intervention Type DRUG

Sugar pill manufactured to mimic guanfacine tablets

Interventions

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Guanfacine XR 3mgs/daily

Guanfacine 3mg tablet

Intervention Type DRUG

Placebo (for guanfacine)

Sugar pill manufactured to mimic guanfacine tablets

Intervention Type DRUG

Other Intervention Names

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Intuniv Sugar pill

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No