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

NCT03137082 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: R21AA024880
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Abstinence

Keywords

Alcohol Use Disorder; Guanfacine; Stress; Craving; Gender; Relapse

Outcome Measures

Primary Outcomes (3)

• Percentage of Days Abstinent

  Percentage of days abstinent across the 12-week trial was calculated using the Timeline follow Back.

  12 weeks

• Percentage of Heavy Drinking Days

  Percentage of heavy drinking days across the 12-week trial was calculated using the Timeline follow Back.

  12 weeks

• Alcohol Consumption (Percentage of Negative Urines)

  Urine screening will be conducted twice per week across the trial.

  12 weeks

Secondary Outcomes (10)

• Mood (Anxiety)

  2 times per week for 12 weeks

• Mood (Depression)

  2 times per week for 12 weeks

• Alcohol Craving

  12-weeks

• Emotion Regulation (Difficulties in Impulse Control)

  12-weeks

• Emotion Regulation (Difficulties With Engaging in Goal Related Behavior)

  12-week

Study Arms (2)

Guanfacine XR 3mgs/daily

EXPERIMENTAL

* 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)

Drug: Guanfacine XR 3mgs/daily

Placebo (for guanfacine)

PLACEBO COMPARATOR

* 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)

Drug: Placebo (for guanfacine)

Interventions

Guanfacine XR 3mgs/daily DRUG

Guanfacine 3mg tablet

Also known as: Intuniv

Guanfacine XR 3mgs/daily

Placebo (for guanfacine) DRUG

Sugar pill manufactured to mimic guanfacine tablets

Also known as: Sugar pill

Placebo (for guanfacine)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

The Health Sciences Center

Stony Brook, New York, 11794, United States

Location

Related Publications (5)

• 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.

  PMID: 24395021 BACKGROUND

• 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.

  PMID: 19373619 BACKGROUND

• 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.

  PMID: 1913155 BACKGROUND

• 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.

  PMID: 12724157 BACKGROUND

• Konjusha A, Colzato L, Ghin F, Stock AK, Beste C. Auricular transcutaneous vagus nerve stimulation for alcohol use disorder: A chance to improve treatment? Addict Biol. 2022 Sep;27(5):e13202. doi: 10.1111/adb.13202.

  PMID: 36001426 DERIVED

MeSH Terms

Conditions

Alcohol Abstinence; Alcoholism; Coitus; Recurrence

Interventions

Guanfacine; Sugars

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Sexual Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Carbohydrates

Limitations and Caveats

Delay in study commencement and staff losses leading to small sample size.

Results Point of Contact

• Title: Dr Helen C Fox
• Organization: Stony Brook University

helen.fox@stonybrookmedicine.edu

631 632 0057

Study Officials

• Helen C Fox, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 2, 2017
• Study Start: July 12, 2017
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: June 5, 2024
• Results First Posted: June 5, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)