Semaglutide for Alcoholism

Overseen By Caitlin Smith, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Yale University

Must not be taking: Weight loss drugs, GLP-1 agonists

Disqualifiers: Pancreatitis, Thyroid carcinoma, Hypertension, Diabetes, Psychiatric conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Semaglutide, a medication typically used for weight management, can aid individuals with Alcohol Use Disorder, particularly after weight-loss surgery such as gastric bypass or sleeve gastrectomy. The goal is to determine if this medication effectively reduces alcohol use. Participants who have undergone weight-loss surgery in the past three years, have a BMI over 30, and meet the criteria for Alcohol Use Disorder may be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants an opportunity to contribute to groundbreaking research.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be using other weight loss medications or GLP-1 receptor agonists. It's best to discuss your specific medications with the study team.

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

Research has shown that semaglutide is generally safe for patients. In a study involving adults with alcohol use disorder, semaglutide did not cause serious side effects. Participants received weekly doses, and most tolerated the treatment well. Some experienced mild side effects like nausea or headache, but these were neither severe nor long-lasting.

The FDA has also approved semaglutide for other conditions, such as type 2 diabetes and weight management, indicating confidence in its safety. Although this trial is in an early stage, semaglutide's existing safety record in other uses is reassuring. ^{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 involve behavioral therapy and medications like naltrexone or acamprosate, semaglutide is gaining attention for its potential new approach. Semaglutide works by mimicking a hormone called GLP-1, which can influence both appetite and reward pathways in the brain. This unique mechanism may help reduce alcohol cravings and consumption. Researchers are excited about semaglutide because it targets these pathways differently, offering a fresh strategy for managing alcohol use disorder.

What evidence suggests that Semaglutide might be an effective treatment for Alcohol Use Disorder?

Research has shown that semaglutide, which participants in this trial may receive, can help individuals with Alcohol Use Disorder reduce cravings for alcohol and decrease consumption. Specifically, studies found that over nine weeks, semaglutide significantly decreased the desire to drink and reduced alcohol intake by about two standard drinks. It also reduced heavy drinking days by 57% compared to those not taking the drug. These results suggest that semaglutide might effectively help individuals drink less and better manage their alcohol use. ^{1 3 5 6 7}

Who Is on the Research Team?

Valentina Ivezaj, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults with obesity who've had bariatric surgery in the last 3 years, have Alcohol Use Disorder but no other substance abuse or severe psychiatric conditions. Participants must be willing to follow study procedures for up to 9 months and use effective contraception if of reproductive potential.

Inclusion Criteria

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study (up to 9 months: 3-month treatment plus 6-month follow up)

Meet current DSM-5 criteria for Alcohol Use Disorder

Exclusion Criteria

Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression)

Has a recent history of substance use disorder (with the exception of cannabis or tobacco use disorder) within the past 12 months

Is currently engaging in other treatment for Alcohol Use Disorder or making intentional efforts to quit alcohol use

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Semaglutide with dose escalation over three months

12 weeks

Weekly visits for dose administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up assessments at 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide

Trial Overview

The trial is testing Semaglutide's effectiveness in treating Alcohol Use Disorder after metabolic and bariatric surgery. It involves a treatment phase of 3 months followed by a 6-month follow-up to assess feasibility and outcomes.

How Is the Trial Designed?

Group I: Semaglutide Experimental Treatment 1 Intervention

Participants randomized to Semaglutide will be initiated on a 0.25 mg dose (injection) once weekly for 4 weeks (first month) with an escalation to 0.5 mg for the second month, and 1.0 mg in the final month. Participants will be on Semaglutide for three months total.

Group II: Wait-list control Active Control 1 Intervention

Participants randomized to wait-list control will be followed for three months but no treatment will be administered. At the conclusion of the study, participants in the wait list control group will be offered a three-month behavioral intervention to treat Alcohol Use Disorder, although this is not required.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

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 ...

... semaglutide is associated with a 50%-56% reduced risk for both the incidence and recurrence of alcohol use disorder in real-world populations.

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 ...