Guanfacine extended-release to reduce drinking in people with alcohol use disorder
Guanfacine for Alcohol Use Disorder (AUD): a Telehealth Approach
PHASE2 · Indiana University · NCT06629259
We will test whether taking guanfacine extended-release (3 mg daily) helps reduce drinking in adults with moderate to severe alcohol use disorder over 12 weeks.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University (other) |
| Locations | 2 sites (Indianapolis, Indiana and 1 other locations) |
| Trial ID | NCT06629259 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled Phase 2 trial will enroll 200 adults with moderate to severe alcohol use disorder across two sites (Indiana University and Rutgers) and follow them for 12 weeks. Participants will be randomized to guanfacine XR (titrated to 3 mg/day over three weeks, maintained for seven weeks, then tapered for two weeks) or matching placebo. The study uses frequent remote monitoring including three daily BAC measures, brief ecological reports of drinking, stress, craving and mood at baseline and steady state, daily encrypted medication videos, and twice-weekly remote safety and medication-management visits. Investigators plan to examine overall drinking outcomes and whether women show greater benefit than men.
Who should consider this trial
Good fit: Adults (≥18) with moderate to severe alcohol use disorder who want to quit drinking, meet health and BMI (18–35) requirements, can provide informed consent and a positive alcohol urine on entry, and can complete remote and in-person visits are ideal candidates.
Not a fit: People with other moderate-to-severe substance use disorders (except nicotine), active psychosis or severe psychiatric instability, or medical contraindications to guanfacine are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, guanfacine XR could provide a new medication option that reduces drinking, cravings, and stress-related relapse for people with alcohol use disorder, potentially with greater benefit in women.
How similar studies have performed: Guanfacine and related adrenergic agents have shown promise in preclinical work and small clinical studies for reducing stress-triggered drinking, but large randomized trials in AUD are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Indianapolis, Indiana and 1 other locations
- The Stark Neuroscience Building (Goodman Hall) — Indianapolis, Indiana, United States (RECRUITING)
- Rutgers School of Health Professionals — Newark, New Jersey, United States (RECRUITING)
Study contacts
- Principal investigator: Helen C Fox, PhD — Associate Professor
- Study coordinator: Helen C Fox, PhD
- Email: helfox@iu.edu
- Phone: 2036719643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alcohol Use Disorder, Stress, Guanfacine, Sex Differences