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

Trial Summary

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.

How is the drug tirzepatide unique for treating alcoholism?

Tirzepatide is unique because it is a dual-action drug that targets both GIP and GLP-1 receptors, which are involved in insulin secretion and appetite regulation, potentially offering a novel approach to treating alcoholism by affecting brain regions that control food and possibly alcohol intake. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a pilot, 4-week, double-blind, placebo-controlled, randomized trial of individuals with alcohol use disorder (AUD) to receive weekly injections of either tirzepatide (n=10) or matching placebo (n=10). The primary aim is to determine the effects of tirzepatide on cue-reactivity among individuals with AUD. The secondary aim is to assess the safety and preliminary efficacy of tirzepatide for AUD.

Research Team

Joji Suzuki, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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.

I or my family have a history of medullary thyroid cancer or MEN2.

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Tirzepatide: A New Generation Therapeutic for Diabetes Type 2. [2023]

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The impact of tirzepatide and glucagon-like peptide 1 receptor agonists on oral hormonal contraception. [2023]

4. Switzerland 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? [2023]

5. England pubmed.ncbi.nlm.nih.gov

Tirzepatide: Clinical review of the "twincretin" injectable. [2023]