Suvorexant for Alcoholism

Overseen By Stephanie Gorka

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ohio State University

Must not be taking: Psychotropics, Antihistamines, CYP3A inducers, others

Disqualifiers: Schizophrenia, Bipolar, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if suvorexant, a sleep aid medication, can effectively treat alcohol use disorder (AUD) and reduce stress reactions. Researchers will compare suvorexant to a placebo to assess its effectiveness. Participants will take either suvorexant or a placebo pill nightly for eight weeks while tracking their alcohol use, sleep, and mood. The trial seeks individuals currently seeking treatment for alcohol use disorder who have a pattern of heavy drinking (14+ drinks a week for men, 7+ for women). As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop my current medications to join the trial?

Yes, you will need to stop taking any medications for alcohol use disorder, psychotropic medications, antihistamines, and certain other medications that may interact with the trial drug. Please consult with the study physician for specific guidance.

Is there any evidence suggesting that suvorexant is likely to be safe for humans?

Research has shown that suvorexant has been studied for its safety in treating alcohol use disorder (AUD). In earlier studies, it reduced alcohol cravings and improved physical and mental health, as well as sleep quality. These results suggest that participants tolerated suvorexant well.

Suvorexant is also being tested as a safe way to manage sleep problems in people with alcohol dependence, supporting its potential safety for those with AUD.

Additionally, the FDA has already approved suvorexant for treating insomnia, indicating a known safety record for that use, even though it is being explored for a new purpose here.

While this trial remains in the early stages, initial findings suggest suvorexant could be a safe option for addressing alcohol use issues. ^{1 2 3 4 5}

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

Suvorexant is unique because it targets the brain's orexin system, which plays a role in regulating wakefulness and is now being explored for its potential to curb alcohol cravings. Unlike standard treatments for alcoholism, which often include medications like naltrexone or acamprosate that focus on reducing the rewarding effects of alcohol or stabilizing brain chemistry, suvorexant offers a novel mechanism by impacting sleep and craving pathways. Researchers are excited because this approach could address both sleep disturbances and alcohol dependency, offering a dual benefit that current options don't provide.

What evidence suggests that suvorexant might be an effective treatment for alcohol use disorder?

Research has shown that suvorexant, which participants in this trial may receive, might help people with alcohol use disorder by reducing cravings and improving both physical and mental health. Studies have found that it can also aid sleep, often disrupted by alcohol use and a factor in relapse. In animal studies, suvorexant lowered alcohol consumption and helped prevent stress-induced relapses. These findings suggest that suvorexant could be a promising option for treating alcohol use disorder by addressing both alcohol cravings and sleep problems. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with moderate to severe alcohol use disorder, who drink heavily and are seeking treatment. Participants should be generally healthy and able to consent. It's not specified who can't join because the exclusion criteria were cut off.

Inclusion Criteria

I am generally healthy without major medical or neurological issues.

I am willing and able to agree to participate in the study.

I have been diagnosed with a moderate to severe alcohol use problem.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take 10mg capsules of SUV or a placebo orally each night before bedtime for 8 weeks

8 weeks

3 visits (in-person) at baseline, 4 weeks, and 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Suvorexant

Trial Overview The study tests if Suvorexant (SUV), a drug taken as a 10mg capsule nightly for 8 weeks, helps treat alcohol use disorder compared to a placebo. It includes lab visits and daily smartphone reports on side effects, sleep, drinking habits, and mood.

How Is the Trial Designed?

Group I: Suvorexant Experimental Treatment 1 Intervention

Individuals will take 10mg of suvorexant (Merck \& Co Inc.) daily for 8-weeks.

Group II: Control Placebo Group 1 Intervention

Individuals will take a placebo pill daily for 8-weeks.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11063611/

The dual orexin receptor antagonist suvorexant in alcohol ... We demonstrate improvements in alcohol cravings, physical and psychological health, and sleep outcomes with treatment. These data support ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03897062

Suvorexant in the Management Comorbid Sleep Disorder ... This proposal aims to evaluate the use of suvorexant as a safe and effective pharmacotherapy to treat sleep disorders in alcohol dependent patients.

3. frontiersin.org frontiersin.org/journals/behavioral-neuroscience/articles/10.3389/fnbeh.2022.1085882/full

Alternative use of suvorexant (Belsomra®) for the ... Suvorexant at 5, 10, and 20 mg/kg selectively decreased alcohol intake in dependent rats. Furthermore, 5 mg/kg SUV prevented the stress-induced reinstatement of ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/ccr3.8740

The dual orexin receptor antagonist suvorexant in alcohol ... We demonstrate improvements in alcohol cravings, physical and psychological health, and sleep outcomes with treatment. These data support ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006899318304190

A sleeping giant: Suvorexant for the treatment of alcohol ... Suvorexant may address alcohol-induced sleep disruptions, which may in turn help reduce or prevent relapse.

6. tandfonline.com tandfonline.com/doi/full/10.1080/17512433.2025.2573787

Full article: The orexin system and alcohol use disorder Suvorexant (5 mg/kg) also prevented stress-induced reinstatement of alcohol drinking in only dependent rats in the same study.

7. scripps.edu scripps.edu/news-and-events/press-room/2023/20230110-martin-fardon-alcohol.html

Scripps Research study suggests insomnia drug could be ... Treatment with suvorexant, however, reduced the rats' alcohol use during withdrawal to the same low levels seen in rats that had no alcohol ...