Tirzepatide for Alcoholism

(STREAM Trial)

Recruiting at 1 trial location

Overseen By Laura M Holsen, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Brigham and Women's Hospital

Must not be taking: GLP-1 agonists, Anti-obesity, Glucose-lowering, AUD medications

Disqualifiers: Substance use disorder, Diabetes, Eating disorders, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether tirzepatide, a medication, helps people with alcohol use disorder (AUD) respond less to cues that might trigger drinking. Participants will take part in a short, four-week study, receiving either tirzepatide injections or a placebo (a harmless substance with no effect) to compare results. The researchers aim to ensure its safety and assess its effectiveness for AUD. Suitable candidates have been diagnosed with AUD, are receiving treatment for alcohol withdrawal at Brigham and Women's Faulkner Hospital, and can attend follow-up visits. 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?

Yes, you will need to stop taking any medications for alcohol use disorder, anti-obesity medications, or medications with glucose-lowering properties at least 30 days before joining the trial.

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

Research shows that tirzepatide, a treatment used for other health issues, is generally well-tolerated. In studies focused on obesity, tirzepatide has proven safe. Most participants experienced mild side effects like nausea or diarrhea, while serious side effects were rare.

Although tirzepatide hasn't been widely tested for alcohol use disorder, similar drugs have undergone study. These studies suggest they can be safe for people with alcohol problems. Given tirzepatide's history, it is expected to be similarly safe in this new area of research.

This trial is in the early stages of testing tirzepatide for alcohol use disorder. While there isn't much data yet on its safety for this specific use, the current information is promising. ^{1 2 3 4 5}

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

Tirzepatide is unique because it targets the GLP-1 receptor, which is different from most standard treatments for alcoholism that typically involve behavioral therapies or medications like naltrexone, acamprosate, and disulfiram. This novel mechanism could offer a new way to reduce cravings and alcohol consumption by influencing metabolic pathways. Researchers are excited about tirzepatide because it has the potential to address addiction through biological means, providing an alternative or complementary option to existing therapies that focus more on behavior and psychological support.

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

This trial will compare tirzepatide with a saline placebo to evaluate its effectiveness in reducing alcohol cravings. Studies have shown that tirzepatide, a medication targeting specific brain signals, can help reduce the urge to drink alcohol. Research indicates that it works by affecting brain signals related to alcohol use. Similar studies have found that other medications significantly reduce alcohol cravings and consumption. Early findings suggest that tirzepatide's unique mechanism may offer a promising approach for those struggling with alcohol use disorder. While more research is needed, these initial results are encouraging for its potential effectiveness. ^{2 6 7 8 9}

Who Is on the Research Team?

Joji Suzuki, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with alcohol use disorder (AUD). Participants will be randomly chosen to receive either the study drug, Tirzepatide, or a saline placebo through weekly injections. The main goal is to see how Tirzepatide affects their response to alcohol-related cues.

Inclusion Criteria

Diagnosed with current DSM-5 alcohol use disorder

I am admitted to BWF's ARP for alcohol withdrawal treatment.

Willing to travel to BWH CCI outpatient facilities for study visits after discharge from the BWF ARP

Exclusion Criteria

I have never been diagnosed with an eating disorder.

Calcitonin ≥ 50 ng/L

Anticipated to be enrolled in another clinical drug trial during participation in this trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

2 visits (in-person)

Treatment

Participants receive weekly injections of tirzepatide or placebo for 4 weeks

4 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Tirzepatide

Trial Overview The trial tests the impact of Tirzepatide on people with AUD compared to a saline placebo. It's designed as a double-blind study, meaning neither participants nor researchers know who receives the actual medication versus the placebo.

How Is the Trial Designed?

Group I: Tirzepatide Experimental Treatment 1 Intervention

This arm will receive tirzepatide (n=10) weekly 2.5mg injections for 4 weeks.

Group II: Saline Placebo Placebo Group 1 Intervention

This arm will receive saline placebo injections (n=10) weekly for 4 weeks.

Tirzepatide is already approved in United States, European Union, Canada, United Kingdom for the following indications:

Approved in United States as Mounjaro for:

• Type 2 diabetes

Approved in European Union as Mounjaro for:

• Type 2 diabetes

Approved in Canada as Mounjaro for:

• Type 2 diabetes

Approved in United States as Zepbound for:

• Weight loss
• Moderate to severe obstructive sleep apnea

Approved in United Kingdom as Zepbound for:

• Weight loss

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Published Research Related to This Trial

Tirzepatide, a dual GIP and GLP-1 receptor agonist, has a safety profile similar to other GLP-1 receptor agonists, but higher doses (10mg and above) are associated with increased risks of hypoglycemia and treatment discontinuation.

In clinical trials involving 9818 patients, higher doses of tirzepatide led to more frequent gastrointestinal side effects like nausea, vomiting, and diarrhea, indicating that these adverse events are dose-dependent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the safety of tirzepatide-a new dual GLP1 and GIP agonist - is its safety profile acceptable? Meng, Z., Yang, M., Wen, H., et al.[2023]

Tirzepatide, approved in 2022, is a novel treatment for type 2 diabetes that acts on both GLP-1 and GIP pathways, showing significant efficacy in lowering blood sugar levels and promoting weight loss in various patient groups.

Clinical trials, including the SURPASS and SURMOUNT studies, indicate that tirzepatide has a safety profile similar to traditional GLP-1 receptor agonists, with common gastrointestinal side effects, making it a promising option for patients needing better glycemic and weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: Clinical review of the "twincretin" injectable. Krauss, Z., Hintz, A., Fisk, R.[2023]

Tirzepatide, the first dual GIP/GLP-1 receptor co-agonist approved for type 2 diabetes, significantly reduces HbA1c levels (by 1.24 to 2.58%) and body weight (by 5.4-11.7 kg) in clinical trials involving type 2 diabetic patients, outperforming the selective GLP-1 RA semaglutide.

The safety profile of tirzepatide is similar to that of other GLP-1 receptor agonists, with common side effects including nausea and diarrhea, and it shows potential cardiovascular safety, as no significant increase in major adverse cardiovascular events was observed during the trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regrading glycaemic control and body weight reduction. Nauck, MA., D'Alessio, DA.[2022]

Tirzepatide, a new medication approved by the FDA, acts as an agonist for both GLP-1 and GIP receptors, which helps improve blood sugar control in patients with type II diabetes when combined with diet and exercise.

This drug represents a significant advancement in diabetes management, offering a new approach to treatment by targeting multiple pathways involved in glucose regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: A New Generation Therapeutic for Diabetes Type 2. Al-Horani, RA., Chedid, M.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06994338

NCT06994338 | Tirzepatide for Alcohol Use Disorder The objective of this Phase 2 randomized controlled trial is to evaluate the effects of weekly tirzepatide (vs. placebo) on alcohol consumption and ...

2. 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 ...

3. reporter.nih.gov reporter.nih.gov/project-details/11192379

Phase II Evaluation of Tirzepatide in Adults with Alcohol ... Tirzepatide, the first dual GLP-1 and GIP (glucose-dependent insulinotropic polypeptide) receptor agonist, shows superior efficacy for weight loss compared to ...

4. nature.com nature.com/articles/s41598-023-48267-2

Semaglutide and Tirzepatide reduce alcohol consumption ... Among the alcohol-related posts (n = 1580), 71% were identified as craving reduction, decreased desire to drink, and other negative effects. In ...

5. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.70169

Relative efficacy of GLP‐1 and GLP‐1/GIP receptor agonists ... The mean follow-up time was 473 days in the tirzepatide arm and 445 days in the DPP4i arm. TABLE 2. Primary and secondary outcomes of alcohol- ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07046819

Study Details | NCT07046819 | Tirzepatide in MetALD This study will evaluate the efficacy and safety of tirzepatide as a novel treatment for alcohol use disorder (AUD) and metabolic alcohol-associated liver ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11786240/

Effects of GLP‐1 Receptor Agonists in Alcohol Use Disorder This review presents the existing data from animal studies in rodents and non‐human primates, clinical trials, register studies and social media ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.16679

The association between glucose‐dependent ... First, this study aims to estimate the strength of association between GIP/GLP-1 RA prescriptions and incident opioid overdose and alcohol ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0033062024001798

Tirzepatide and semaglutide for treating obesity-related ... Tirzepatide and semaglutide, unlike prior weight-loss drugs, are effective and relatively safe/well-tolerated medications that are associated with reduced risks ...