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Clinical trial

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

ID
Name
R21AA024880
Description
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.
Trial arms
Trial start
2017-07-12
Estimated PCD
2021-03-31
Trial end
2021-03-31
Status
Completed
Phase
Early phase I
Treatment
Guanfacine XR 3mgs/daily
Guanfacine 3mg tablet
Arms:
Guanfacine XR 3mgs/daily
Other names:
Intuniv
Placebo (for guanfacine)
Sugar pill manufactured to mimic guanfacine tablets
Arms:
Placebo (for guanfacine)
Other names:
Sugar pill
Size
32
Primary endpoint
Percentage of Days Abstinent
12 weeks
Percentage of Heavy Drinking Days
12 weeks
Alcohol Consumption (Percentage of Negative Urines)
12 weeks
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}
Updated at
2024-06-05

1 organization

2 products

1 indication

Organization
Stony Brook University
Product
Guanfacine XR
Indication
Alcohol Abstinence
Product
Placebo