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

September 4, 2018 updated by: Helen Fox, Stony Brook University
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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Guanfacine 3mg tablet
Other Names:
  • Intuniv
Placebo Comparator: 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)
Sugar pill manufactured to mimic guanfacine tablets
Other Names:
  • Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol Consumption
Time Frame: 10 weeks
Ethyl glucuronide (Etg) urine toxicology screens will be collected two times per week, to assess drinking status
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 weeks
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.
10 weeks
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
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Helen C Fox, PhD, Stony Brook University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

April 24, 2017

First Submitted That Met QC Criteria

April 27, 2017

First Posted (Actual)

May 2, 2017

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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