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Alpha-2 Adrenergic Agonist

Guanfacine for Alcohol Use Disorder

Phase 2

Recruiting

Led By Sherry McKee, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Drinking criteria: Males Drinks more than 14 drinks per week and exceeds 4 drinks per day at least twice per week; Females Drinks > more than drinks per week and exceeds 3 drinks per day at least twice per week. Must meet drinking criteria during a consecutive 30 day period prior to baseline

Age 21-70

Must not have

Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives [oral, implant, injection, patch, or ring], contraceptive sponge, double barrier [diaphragm or condom plus spermicide], or IUD)

Suicidal, homicidal or evidence of current (past 6 month) mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 120 minutes

Summary

This trial will study how well guanfacine works in treating stress and stimulation-based drinking behavior, and will compare how it affects men and women.

Who is the study for?

This trial is for adults aged 21-70 with alcohol use disorder, as defined by DSM V criteria. Participants must be English literate, able to take oral medication, and willing to reduce drinking. Excluded are those using psychoactive drugs or with significant mental health issues, cardiovascular problems, liver/renal impairment, or a history of severe alcohol withdrawal.

What is being tested?

The study tests whether Guanfacine ER can help control stress-induced and stimulation-based drinking behaviors in men and women with alcohol use disorders. It also looks at how it affects their overall treatment outcomes compared to a placebo.

What are the potential side effects?

Guanfacine may cause side effects like drowsiness, dry mouth, constipation, headache, fatigue and potentially lower blood pressure which could lead to fainting or heart-related issues in some individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a male who drinks more than 14 drinks weekly and exceeds 4 drinks per day twice a week, or I am a female who drinks more than 7 drinks weekly and exceeds 3 drinks per day twice a week.

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I am between 21 and 70 years old.

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I can take pills and will follow the medication plan.

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I am between 21 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or nursing and use effective birth control or am surgically sterile/postmenopausal.

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I have not had any severe mental health issues like schizophrenia, bipolar disorder, major depression, or anxiety in the past 6 months.

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I do not have any major health issues like heart problems, kidney or liver disease, seizures, or HIV.

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I want to stop drinking alcohol completely.

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I have used drugs for mental health, like anxiety or depression meds, in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~120 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Alcohol Consumption

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Guanfacine ERExperimental Treatment1 Intervention

Guanfacine extended release (6mg/day ER). Administered orally twice daily at 8:00 AM and 8:00 PM while titrating to the full dose. Titration schedule: Days 1-3 1mg/day; 0.5mg/dose, Days 4-6 2mg/day; 1mg/dose, Days 7-9 3mg/day; 1.5mg/dose, Days 10-12 4mg/day; 2mg/dose; Days 13-15 5mg/day; 2.5mg/dose and Days 16-23 6mg/day; 3mg/dose. Once at steady state, administration is orally once per day at 8:00 PM.

Group II: PlaceboPlacebo Group1 Intervention

Administered orally twice a day at 8:00 AM and 8:00 PM Days 1-23, then orally once a day at 8:00 PM.

0 / 9Eligibility criteria met