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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 minutes
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
Select...
I am between 21 and 70 years old.
Select...
I can take pills and will follow the medication plan.
Select...
I can take pills and will follow the medication plan.
Select...
I am between 21 and 70 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
796 Previous Clinical Trials
1,361,263 Total Patients Enrolled
420 Trials studying Alcoholism
984,785 Patients Enrolled for Alcoholism
Yale UniversityLead Sponsor
1,841 Previous Clinical Trials
2,734,367 Total Patients Enrolled
82 Trials studying Alcoholism
10,076 Patients Enrolled for Alcoholism
Sherry McKee, PhDPrincipal Investigator - Yale University
Yale University
5 Previous Clinical Trials
276 Total Patients Enrolled
1 Trials studying Alcoholism
10 Patients Enrolled for Alcoholism

Media Library

Guanfacine ER (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03764098 — Phase 2
Alcoholism Research Study Groups: Placebo, Guanfacine ER
Alcoholism Clinical Trial 2023: Guanfacine ER Highlights & Side Effects. Trial Name: NCT03764098 — Phase 2
Guanfacine ER (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03764098 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical research include participants who are of adult age?

"This research project stipulates that the minimum age for participation is 21 and no patient over 70 years old can join."

Answered by AI

Has Guanfacine ER ever been the subject of prior clinical investigations?

"At the present time, there are 9 operational clinical trials analyzing Guanfacine ER with 2 of them in Phase 3. Although a portion of these tests for Guanfacine ER is taking place out of Palo Alto, California, there are 80 trial sites scattered across the nation."

Answered by AI

Has Guanfacine ER been given clearance by the FDA?

"Evaluating the safety of Guanfacine ER, our team assigned a rating of 2. This is owing to the fact that this Phase 2 trial has accrued some data indicating its security but no evidence verifying efficacy yet."

Answered by AI

What is the upper limit of individuals taking part in this investigation?

"Affirmative. The information presented on clinicaltrials.gov implies that this medical trial is being actively pursued, with the first post dated 8/10/2020 and the most recent update at 3/11/2022. 160 participants are required to be recruited from 1 site in total."

Answered by AI

Is this a previously untested experiment?

"Since 2018, research has been conducted on Guanfacine ER. This medication was initially studied in a 20-person trial sponsored by Shire and following its success it received N/A drug approval. As of now, nine clinical studies are ongoing across 24 cities and nine different countries."

Answered by AI

What conditions does Guanfacine ER typically address?

"Guanfacine ER is a medication utilized to address migraine, as well as attention deficit hyperactivity disorder (ADHD), hypertensive disease, and the prevention of migraines."

Answered by AI

Am I eligible to participate in this research?

"To be considered for admission to this experiment, applicants must demonstrate drinking behavior and fall within the age demographic of 21-70. In total, 160 individuals will be admitted into the trial."

Answered by AI

Are there still vacancies in this clinical experiment for participants?

"According to the clinicaltrials.gov database, this medical trial is actively searching for participants. It was initially posted on August 10th 2020 and most recently updated on March 11th 2022."

Answered by AI
~33 spots leftby Feb 2025