Semaglutide for Alcoholism

(CRAVE Trial)

Overseen By Neil C Johnson, MA BA

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VA Office of Research and Development

Must not be taking: Antidepressants, Antianxiety, Insulin, others

Disqualifiers: Diabetes, Schizophrenia, Hepatitis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called semaglutide to determine its effectiveness in reducing heavy drinking among Veterans with moderate to severe alcohol use disorder (AUD). Participants will receive either semaglutide or a placebo, and results will be compared over several months. The researchers aim to establish whether semaglutide can serve as a safe and effective treatment for AUD. Veterans with recent risky drinking levels who meet specific AUD criteria may qualify for this study. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment for AUD.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. If you are currently using medications for alcohol use disorder or certain diabetes medications, you must stop them at least 30 days before starting the trial. Also, if you've recently changed doses of psychiatric medications, you need to wait 2 months before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that semaglutide, a medication for diabetes and weight loss, is being tested for alcohol use disorder (AUD). Studies have found that it can reduce both the urge to drink and the amount consumed by some individuals. Semaglutide is generally easy to take, with most side effects being mild, such as nausea, which often improves over time.

Since this trial is in a later stage, extensive safety information is already available, indicating that semaglutide is safe enough for further testing. Participants will begin with a small dose that gradually increases to help manage any side effects. If semaglutide is already approved for other uses, it typically indicates a strong safety record. ^{1 2 3 4 5}

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

Researchers are excited about semaglutide for alcoholism because it offers a unique approach compared to current treatments like naltrexone, acamprosate, or disulfiram. Unlike these medications, which typically aim to reduce cravings or produce adverse reactions to alcohol, semaglutide works by mimicking a hormone called GLP-1, which helps regulate appetite and may influence alcohol consumption behavior. Additionally, semaglutide is administered through weekly subcutaneous injections, which could be more convenient for some patients compared to daily oral medications. This novel mechanism and delivery method give researchers hope for a new and effective option in treating alcohol use disorder.

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

Research shows that semaglutide, a type of medication, may help reduce alcohol use. In earlier studies, people taking semaglutide experienced fewer days of heavy drinking and consumed about two fewer standard drinks. It also reduced their cravings for alcohol. In this trial, participants will receive either semaglutide or a placebo. Specifically, participants who took semaglutide in previous studies drank less on days they consumed alcohol compared to those who took a placebo. These results suggest that semaglutide could effectively help people with alcohol use disorder (AUD) drink less. ^{1 2 4 6 7}

Who Is on the Research Team?

David W. Oslin, MD

Principal Investigator

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Are You a Good Fit for This Trial?

This trial is for U.S. Veterans with moderate to severe alcohol use disorder who are seeking treatment. Participants must be willing to receive injections and follow up for a total of 32 weeks. Specific eligibility criteria details were not provided, so it's important to contact the study team for full inclusion and exclusion requirements.

Inclusion Criteria

Veteran

WHO risk drinking level of Very High or High in the 30 days prior to screening

Current diagnosis of moderate or severe AUD (meeting at least 4 of 11 DSM-5 AUD criteria)

Exclusion Criteria

Known hypersensitivity reaction to semaglutide or related products

I am currently taking medication that lowers my blood sugar.

I have had severe diabetic eye disease.

Timeline for a Trial Participant

Recruitment, Consent and Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Dose Initiation

Participants are randomized and begin initial dosing of semaglutide or placebo

4 weeks

1 visit (in-person)

Endpoint Ascertainment Period

Participants receive semaglutide or placebo with dose titration and are monitored for reduction in risky drinking

24 weeks

6 visits (in-person)

Post-Treatment Safety Assessment

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide

Trial Overview The trial tests semaglutide, a medication that affects appetite and insulin regulation, against a placebo to see if it can help reduce or stop alcohol consumption in veterans with AUD. It involves weekly injections over 28 weeks, with doses increasing based on tolerance.

How Is the Trial Designed?

Group I: Semaglutide Experimental Treatment 1 Intervention

Weekly subcutaneous injections of semaglutide up to 2.4 mg/week or maximum tolerated dose. Initial dosing starting at 0.25 for weeks 1-4. Further titration up to 2.4 mg weekly starting at week 5.

Group II: Placebo Placebo Group 1 Intervention

Weekly subcutaneous injections of placebo.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2829811

Once-Weekly Semaglutide in Adults With Alcohol Use ... Over 9 weeks of treatment, semaglutide led to reductions in some but not all measures of weekly consumption, significantly reduced weekly alcohol craving ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11822619/

Once-Weekly Semaglutide in Adults With Alcohol Use Disorder Over 9 weeks of treatment, semaglutide led to reductions in some but not all measures of weekly consumption, significantly reduced weekly ...

3. psychopharmacologyinstitute.com psychopharmacologyinstitute.com/section/semaglutide-for-alcohol-use-disorder-new-rct-data/

03. Semaglutide for Alcohol Use Disorder: New RCT Data Results: Reduced Heavy Drinking Days · Reduced alcohol intake by about 2 standard drinks (26g of alcohol) · Led to a 57% reduction in average ...

4. bbrfoundation.org bbrfoundation.org/content/glp-1-drug-semaglutide-ozempic-wegovy-reduced-heavy-drinking-craving-adults-alcohol-use

GLP-1 Drug Semaglutide (Ozempic, Wegovy) Reduced ... Relative to those in the placebo group, those treated with semaglutide took significantly fewer drinks on days they consumed alcohol, and ...

5. news.unchealthcare.org news.unchealthcare.org/2024/06/clinical-trial-on-semaglutide-shows-promise-for-treatment-of-alcohol-use-disorder-warrants-further-trials/

Clinical Trial on Semaglutide Shows Promise for Treatment ... Preliminary results from the trial indicate that those taking the medication experienced greater reductions in drinking quantity and heavy ...

6. nature.com nature.com/articles/s41467-024-48780-6

Associations of semaglutide with incidence and recurrence ... Given that the previous clinical trial of the GLP-1RA exenatide for AUD found reduced alcohol consumption only in those who were overweight, we ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06015893

Semaglutide Therapy for Alcohol Reduction (STAR) This study will test the safety/tolerability and early efficacy of subcutaneous (s.c.) semaglutide at the dose of 2.4 mg/week or maximum tolerated dose (MTD) as ...