Guanfacine for Alcoholism

Recruiting at 1 trial location

Overseen By Helen C Fox, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Indiana University

Must not be taking: Monophasic contraceptives

Disqualifiers: Substance use disorder, Psychotic, Cardiovascular disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it excludes those who regularly use medications that might be harmful with guanfacine. It's best to discuss your current medications with the trial doctor.

How does the drug Guanfacine Extended Release differ from other treatments for alcoholism?

Guanfacine Extended Release is unique because it is primarily used for treating attention deficit hyperactivity disorder (ADHD) and works by affecting certain receptors in the brain to improve attention and impulse control. This mechanism is different from other alcoholism treatments like naltrexone or disulfiram, which focus on reducing cravings or causing unpleasant reactions to alcohol. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Helen C Fox, PhD

Principal Investigator

Associate Professor

Eligibility Criteria

This trial is for men and women with Alcohol Use Disorder (AUD) who are seeking treatment. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information on who can participate.

Inclusion Criteria

Provide informed verbal and written consent

Demonstrate a positive urine for alcohol on admission to study procedures

Read English and complete study evaluations

Exclusion Criteria

Meet criteria for physiological dependence on alcohol requiring medical detoxification

Be pregnant or breast feeding

Meet criteria for moderate to severe SUD, excluding alcohol and nicotine

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive guanfacine XR or placebo for 12 weeks, with titration to full dose over 3 weeks, 7 weeks at full dose, and 2 weeks tapering off

12 weeks

Twice weekly remote visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Guanfacine Extended Release

Trial Overview The trial is testing if Guanfacine Extended Release (GXR), at a dose of 3mg per day, helps reduce alcohol consumption over a period of 12 weeks compared to a placebo in 200 participants.

Participant Groups

Group I: Guanfacine Extended Release (XR) Experimental Treatment 1 Intervention

Participants receive guanfacine XR, 3mg tablet orally, once per day for 12 weeks

Group II: Placebo Placebo Group 1 Intervention

Participants receive guanfacine XR, placebo tablet orally, once per day for 12 weeks

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

Alcohol use disorder (AUD) is common but often under-treated, with only three approved medications, highlighting the need for more diverse and effective treatment options.

The review discusses various pharmacotherapies, including both approved and novel agents, showing promise for improving treatment efficacy and supporting personalized medicine approaches for individuals with AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Agents for the Pharmacological Treatment of Alcohol Use Disorder. Burnette, EM., Nieto, SJ., Grodin, EN., et al.[2022]

Acamprosate and naltrexone are the only two medications approved for treating alcohol use disorders (AUDs) that have strong evidence from numerous clinical trials, making them effective options for patients.

Several off-label medications, such as topiramate and gabapentin, show promise for treating AUDs, but more research is needed to confirm their efficacy and safety in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of alcoholism - an update on approved and off-label medications. Soyka, M., Müller, CA.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Low-threshold extended-release naltrexone for high utilizers of public services with severe alcohol use disorder: A pilot study. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Novel Agents for the Pharmacological Treatment of Alcohol Use Disorder. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of alcoholism - an update on approved and off-label medications. [2018]

4. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Nalmefene: A Novel Drug for an Old Disorder. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Extended-release naltrexone plus medical management alcohol treatment in primary care: findings at 15 months. [2013]