Clinical trial NCT06629259: Guanfacine for Alcohol Use Disorder (AUD)
Official title: Guanfacine for Alcohol Use Disorder (AUD): a Telehealth Approach
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Alcohol Use Disorder
Keywords: Alcohol Use Disorder
Stress
Guanfacine
Sex Differences
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-10-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized double blind, placebo controlled
Primary purpose: PREVENTION

Brief summary: The investigators assess whether guanfacine extended release (GXR; 3mg/d) compared with placebo (PBO) will attenuate drinking and drinking-related factors in N=200 men and women with Alcohol Use Disorder (AUD) across 12-weeks.

Detailed description: This is a study to examine the efficacy of guanfacine extended release (GXR) (3mg/d) compared with placebo (PBO) in reducing drinking in N=200 men and women with Alcohol Use Disorder (AUD). The study will be conducted across two sites for 12-weeks. Indiana University will be the primary site and Rutgers University, the secondary site. Participants at both sites will be randomized to either GXR (3mg/d) or placebo (PBO), and titrated to full dose over a three week period. After remaining at full dose for 7 weeks a two week schedule will be used to taper participants off the medication. During the study the investigators will collect brief reports throughout the day and evening of drinking severity, stress, craving, mood, arousal, anxiety, and emotion regulation at weeks 1 and 2 (baseline) and weeks 5 and 6 (steady state). Additionally, blood alcohol concentration (BAC) levels will be collected three times per day for the full 12-weeks. Daily encrypted video recordings will be used to monitor medication compliance, and participants will also take part in twice weekly remote visits to assess safety, vitals, collect urines, monitor alcohol use, and receive weekly Medical Management. It is anticipated that guanfacine will demonstrate greater efficacy in women compared to men with AUD.

Eligibility criteria: Inclusion Criteria:

* be assigned as a biological male or female at birth and identify as such
* meet current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM V) criteria for moderate to severe AUD
* be ≥18 years old and have a body mass index (BMI) of 18-35
* express a desire to quit alcohol as determined by the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
* demonstrate a positive urine for alcohol on admission to study procedures
* be able to provide informed verbal and written consent
* be able to read English and complete study evaluations
* be in good health as verified by the intake 1 physical examination

Exclusion Criteria:

* meet criteria for moderate to severe Substance Use Disorder (SUD), excluding alcohol and nicotine
* have a positive screen for substances of abuse, excluding alcohol, nicotine,
* being psychotic or otherwise severely psychiatrically disabled (including suicidal, homicidal, current mania)
* meet criteria for physiological dependence on alcohol requiring medical detoxification
* regular use of medications in the last 6 months that, in the opinion of the site physician may be contraindicated with GXR and be potentially harmful to the participant
* be pregnant or breast feeding
* be using monophasic contraceptives
* have cardiovascular disease including high blood pressure,
* be hypotensive with sitting blood pressure below 100/50 mmHG
* have bradycardia with a sitting heart rate (HR) of \<60 bpm
* show EKG evidence of any clinically significant conduction abnormalities, including a Bazett's corrected QT interval (QTc) \>470 msec for women and QTc\>450 msec for men.

Primary outcomes:
measure: Change in % number of days drinking
timeFrame: five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12
measure: Change in Blood Alcohol Concentration (BAC) levels
timeFrame: three times per day through week 12.
measure: Change in no. of drinks consumed following stress
timeFrame: five times daily during weeks 1, 2, 5, 6
measure: Change in alcohol craving following stress
timeFrame: five times daily during weeks 1, 2, 5, 6
Secondary outcomes:
measure: Change in number of drinks consumed per occasion
timeFrame: five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12
measure: Change in number of binge episodes
timeFrame: five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12
measure: Change in negative mood following stress
timeFrame: five times daily during weeks 1, 2, 5, 6
measure: Change in anxiety following stress
timeFrame: five times daily during weeks 1, 2, 5, 6
measure: Change in arousal following stress
timeFrame: five times daily during weeks 1, 2, 5, 6
measure: Change in emotion regulation following stress
timeFrame: five times daily during weeks 1, 2, 5, 6
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: The Stark Neuroscience Building (Goodman Hall)
state: Indiana
city: Newark
country: United States
facility: Rutgers School of Health Professionals
state: New Jersey
Study officials:
affiliation: Associate Professor
name: Helen C Fox, PhD
role: PRINCIPAL_INVESTIGATOR
References: