Guanfacine for Alcoholism

Recruiting at 1 trial location

Overseen By Mitch Smith

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether guanfacine, an extended-release medication, can reduce drinking in individuals with Alcohol Use Disorder (AUD). Participants will receive either guanfacine or a placebo (a pill with no active drug) for 12 weeks to assess its impact on drinking habits. The trial seeks individuals diagnosed with moderate to severe AUD who wish to quit drinking. Those currently struggling with alcohol and wanting change may be suitable for this study. Participants must be in good health and willing to complete the trial procedures. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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.

Is there any evidence suggesting that guanfacine extended release is likely to be safe for humans?

Research has shown that guanfacine extended release (GXR) is generally well-tolerated. Common side effects include sleepiness, fatigue, insomnia, dizziness, and stomach pain, occurring in over 5% of those using the treatment. These effects are more likely when guanfacine is taken with alcohol or other calming medications. The FDA has approved guanfacine for other uses, indicating its safety. However, this does not guarantee its safety for treating alcohol use disorder. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alcoholism?

Unlike the standard treatments for alcoholism, which often include medications like naltrexone, acamprosate, and disulfiram, guanfacine extended release (XR) operates through a different mechanism. Guanfacine is unique because it primarily targets the brain's alpha-2 adrenergic receptors, which are involved in stress and impulse control. This mechanism could offer a new way to reduce the craving and anxiety associated with alcohol withdrawal. Researchers are excited about guanfacine because it has the potential to improve self-control and reduce alcohol consumption without the side effects commonly seen with other medications.

What evidence suggests that guanfacine extended release might be an effective treatment for alcohol use disorder?

Research has shown that guanfacine extended release (GXR) might help reduce alcohol consumption. In animal studies, guanfacine significantly decreased alcohol intake in rats accustomed to heavy drinking. This suggests the drug might have similar effects in people with Alcohol Use Disorder (AUD). Participants in this trial will receive either guanfacine XR or a placebo to evaluate its effectiveness. Guanfacine affects parts of the brain that control impulses, potentially helping people resist the urge to drink. Although human studies are limited, these early results are promising and warrant further exploration. ^{1 3 4 6 7}

Who Is on the Research Team?

Helen C Fox, PhD

Principal Investigator

Associate Professor

Are You a Good Fit for This Trial?

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

Demonstrate a positive urine for alcohol on admission to study procedures

Provide informed verbal and written consent

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06629259

NCT06629259 | Guanfacine for Alcohol Use Disorder (AUD) 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4367455/

Evaluation of Guanfacine as a Potential Medication for Alcohol ... In this study, both guanfacine and the AUD medication naltrexone significantly decreased voluntary alcohol intake in long-term-drinking rats.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06629259/guanfacine-for-alcohol-use-disorder-aud

Guanfacine for Alcohol Use Disorder (AUD) 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 ...

4. withpower.com withpower.com/trial/phase-2-alcohol-drinking-11-2024-92926

Guanfacine for Alcoholism This Phase 2 medical study run by Indiana University is evaluating whether Guanfacine Extended Release will have tolerable side effects & efficacy for ...

5. researchgate.net researchgate.net/publication/46217865_Sallee_FR_Eaton_K_Guanfacine_extended-release_for_attention-deficithyperactivity_disorder_ADHD_Expert_Opin_Pharmacother_11_2549-2556

Sallee FR, Eaton K. Guanfacine extended-release for ... Guanfacine's effect on human alcohol consumption remains to be investigated; however, we hypothesize that the present results showing that ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2935643/

Guanfacine Extended-Release Tablets (Intuniv), a ... Sedation and somnolence may be experienced if guanfacine ER is taken with alcohol, sedatives, hypnotics, benzodiazepines, barbiturates, or antipsychotic agents.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2013/022037s009lbl.pdf

INTUNIV (guanfacine) extended-release tablets Most common adverse reactions. (≥5% and at least twice placebo rate) in the adjunctive trial: somnolence, fatigue, insomnia, dizziness, and abdominal pain (6).