- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03137082
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
Status
Recruiting
Conditions
Intervention / Treatment
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
- Name: Antoinette Funaro, MS
- Phone Number: 631 638 0057
- Email: antoinette.funaro@stonybrookmedicine.edu
Study Locations
-
-
New York
-
East Setauket, New York, United States, 11794
- Recruiting
- The Clinical Research Center
-
Contact:
- Antoinette Funaro, MS
- Phone Number: 631-638-0057
- Email: antoinette.funaro@stonybrookmedicine.edu
-
Stony Brook, New York, United States, 11794
- Recruiting
- Putnam Hall Outpatient Facility
-
Contact:
- David Schlager, MD
- Phone Number: 631-444-2571
- Email: david.schlager@stonybrookmedicine.edu
-
-
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 3mg tablet
Other Names:
|
Placebo Comparator: Placebo (for guanfacine)
|
Sugar pill manufactured to mimic guanfacine tablets
Other Names:
|
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.
Sponsor
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.
General Publications
- Fox HC, Morgan PT, Sinha R. Sex differences in guanfacine effects on drug craving and stress arousal in cocaine-dependent individuals. Neuropsychopharmacology. 2014 May;39(6):1527-37. doi: 10.1038/npp.2014.1. Epub 2014 Jan 7.
- Fox HC, Sinha R. Sex differences in drug-related stress-system changes: implications for treatment in substance-abusing women. Harv Rev Psychiatry. 2009;17(2):103-19. doi: 10.1080/10673220902899680.
- Heinsbroek RP, van Haaren F, Feenstra MG, Boon P, van de Poll NE. Controllable and uncontrollable footshock and monoaminergic activity in the frontal cortex of male and female rats. Brain Res. 1991 Jun 14;551(1-2):247-55. doi: 10.1016/0006-8993(91)90939-s.
- Cahill L. Sex-related influences on the neurobiology of emotionally influenced memory. Ann N Y Acad Sci. 2003 Apr;985:163-73. doi: 10.1111/j.1749-6632.2003.tb07080.x.
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
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Drinking Behavior
- Alcohol-Related Disorders
- Substance-Related Disorders
- Disease Attributes
- Alcohol Drinking
- Alcoholism
- Recurrence
- Alcohol Abstinence
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Guanfacine
Other Study ID Numbers
- R21AA024880 (U.S. NIH Grant/Contract)
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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