Guanfacine to Reduce Relapse Risk in Women With Alcohol Use Disorder (AUD)
Primary Purpose
Alcohol Abstinence
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Guanfacine XR 3mgs/daily
Placebo (for guanfacine)
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Abstinence focused on measuring Alcohol Use Disorder, Guanfacine, Stress, Craving, Gender, Relapse
Eligibility Criteria
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.
Sites / Locations
- The Clinical Research CenterRecruiting
- Putnam Hall Outpatient FacilityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Guanfacine XR 3mgs/daily
Placebo (for guanfacine)
Arm 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)
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)
Outcomes
Primary Outcome Measures
Alcohol Consumption
Ethyl glucuronide (Etg) urine toxicology screens will be collected two times per week, to assess drinking status
Secondary Outcome Measures
Attrition rate (%)
The percentage number of participants dropping out of the study will be calculated for both the experimental and control group
Alcohol Craving
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
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
Full Information
NCT ID
NCT03137082
First Posted
April 24, 2017
Last Updated
September 4, 2018
Sponsor
Stony Brook University
1. Study Identification
Unique Protocol Identification Number
NCT03137082
Brief Title
Guanfacine to Reduce Relapse Risk in Women With Alcohol Use Disorder (AUD)
Official Title
Guanfacine to Reduce Relapse Risk in Women With Alcohol Use Disorder (AUD)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Recruiting
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abstinence
Keywords
Alcohol Use Disorder, Guanfacine, Stress, Craving, Gender, Relapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Guanfacine XR 3mgs/daily
Arm Type
Experimental
Arm 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)
Arm Title
Placebo (for guanfacine)
Arm Type
Placebo Comparator
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Guanfacine XR 3mgs/daily
Other Intervention Name(s)
Intuniv
Intervention Description
Guanfacine 3mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo (for guanfacine)
Other Intervention Name(s)
Sugar pill
Intervention Description
Sugar pill manufactured to mimic guanfacine tablets
Primary Outcome Measure Information:
Title
Alcohol Consumption
Description
Ethyl glucuronide (Etg) urine toxicology screens will be collected two times per week, to assess drinking status
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Attrition rate (%)
Description
The percentage number of participants dropping out of the study will be calculated for both the experimental and control group
Time Frame
10 weeks
Title
Alcohol Craving
Description
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.
Time Frame
10 weeks
Title
Mood
Description
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
Time Frame
10 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoinette Funaro, MS
Phone
631 638 0057
Email
antoinette.funaro@stonybrookmedicine.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen C Fox, PhD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Clinical Research Center
City
East Setauket
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoinette Funaro, MS
Phone
631-638-0057
Email
antoinette.funaro@stonybrookmedicine.edu
Facility Name
Putnam Hall Outpatient Facility
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Schlager, MD
Phone
631-444-2571
Email
david.schlager@stonybrookmedicine.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24395021
Citation
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.
Results Reference
background
PubMed Identifier
19373619
Citation
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.
Results Reference
background
PubMed Identifier
1913155
Citation
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.
Results Reference
background
PubMed Identifier
12724157
Citation
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.
Results Reference
background
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Guanfacine to Reduce Relapse Risk in Women With Alcohol Use Disorder (AUD)
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