Tirzepatide for Alcoholism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore whether tirzepatide, a drug typically used for diabetes and weight loss, can reduce alcohol cravings in people with alcohol use disorder (AUD). Researchers will use advanced imaging techniques to examine participants' brain responses to the drug. Participants with AUD who have been heavy drinkers for at least two years and are not currently seeking treatment may be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.
Do I have to stop taking my current medications for the trial?
Yes, you may need to stop taking certain medications. The trial excludes participants who have used certain drugs or medications daily in the past two months, such as stimulants, opioids, and some antidepressants. It's best to discuss your current medications with the trial team to see if they are allowed.
Is there any evidence suggesting that tirzepatide is likely to be safe for humans?
Previous studies have shown that tirzepatide reduces alcohol consumption and cravings while making drinking less rewarding. The FDA has already approved tirzepatide for treating diabetes and weight loss, indicating a known safety record.
For alcohol use disorder, research has demonstrated that tirzepatide significantly reduces dopamine release in the brain, the chemical responsible for the rewarding feeling of drinking. Although specific safety data for alcohol use disorder is not yet available, its use in other conditions provides some confidence in its safety for this trial. Participants in those studies tolerated tirzepatide well, with no major safety concerns reported.12345Why do researchers think this study treatment might be promising?
Tirzepatide is unique because it targets multiple pathways involved in alcoholism, potentially offering a new approach compared to traditional treatments like naltrexone or disulfiram, which primarily focus on blocking the effects of alcohol or causing unpleasant reactions to it. Tirzepatide combines the actions of two hormones, GLP-1 and GIP, which are involved in regulating appetite and reward, possibly reducing alcohol cravings and consumption. Researchers are excited about its potential to address both the physical and psychological aspects of alcohol addiction, offering hope for more comprehensive management of the condition.
What evidence suggests that tirzepatide might be an effective treatment for alcoholism?
Research has shown that tirzepatide, a drug often used for diabetes, might help reduce alcohol consumption. Studies have found that tirzepatide lowers alcohol intake in both rats and humans. Specifically, earlier reports indicated that people taking tirzepatide drank less, had healthier livers, and experienced better overall health. Another study found that higher doses of tirzepatide reduced alcohol cravings and stopped binge drinking in animals. In this trial, participants will receive tirzepatide to evaluate its potential to reduce the urge to drink in people with alcohol use disorder.36789
Who Is on the Research Team?
Nora D Volkow Adler, M.D.
Principal Investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Are You a Good Fit for This Trial?
This trial is for adults aged 21-65 who have a history of heavy drinking and meet criteria for mild to moderate alcohol use disorder, or are healthy volunteers. Participants must be willing to follow study procedures and have prior experience with stimulant drugs.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Part 1: Imaging Procedures
Healthy volunteers undergo 2 to 3 PET/MRI scans to assess test/retest reproducibility of the PET/MRI combined scan measures.
Part 2: Randomization to Tirzepatide & Placebo
Participants are randomized to receive either Tirzepatide or Placebo in a crossover design, with weekly subcutaneous injections for 2 to 3 weeks, followed by PET/MRI scans.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a follow-up phone call about 1 month after imaging scans are complete.
What Are the Treatments Tested in This Trial?
Interventions
- Tirzepatide
Trial Overview
The study tests whether tirzepatide (a diabetes/weight loss drug) can reduce cravings in people with alcohol use disorder by comparing it to a placebo. Both groups receive brain scans before and after treatment in a crossover design.
How Is the Trial Designed?
5
Treatment groups
Active Control
Placebo Group
Radiotracer injection of \[11C\]raclopride during combined PET/MR scan to measure striatal dopamine release (Methylphenidate 0.25 mg/kg injected 45 minutes post radiotracer injection). Subject is not blind to this drug during scan.
Radiotracer injection of \[11C\]raclopride during combined PET/MR scan to measure striatal dopamine release (Methylphenidate 0.25 mg/kg injected 45 minutes post radiotracer injection). Subject is not blind to this drug during scan.
1st Dose: Tirpezatide (2.5 mg dose) will be administered to the abdomen.2nd Dose: Tirzepatide (5 mg dose) will be administered to the abdomen. 3rd Dose (if needed): Tirzepatide (5 mg dose) will be administered to the abdomen.Subject is blinded to drug.
\[11C\]NNC-112 PET/MR or PET/CT scan obtained without any drug intervention to measure dopamine D1 receptors.
1st Dose: placebo will be administered to the abdomen.2nd Dose: placebo will be administered to the abdomen. 3rd Dose (if needed): placebo will be administered to the abdomen.Subject is blinded to drug.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Lead Sponsor
Citations
Tirzepatide reduces alcohol drinking and relapse-like ... - PMC
Subsequently, this GLP-1R/GIPR agonist dose-dependently reduced voluntary alcohol consumption (P < 0.001), prevented binge (P < 0.01) and relapse-like drinking ...
Tirzepatide attenuates dopamine reward signaling and ...
Acute tirzepatide treatment dose-dependently reduces alcohol consumption in male and female rats. To further assess tirzepatide's effectiveness ...
Semaglutide and Tirzepatide reduce alcohol consumption ...
In summary, we provide initial real-world evidence of reduced alcohol consumption in people with obesity taking Semaglutide or Tirzepatide ...
Tirzepatide reduced alcohol use in three patients with alcohol ...
After the initiation of tirzepatide, all patients demonstrated decreased alcohol consumption, improved liver function, and better metabolic control. These ...
Study of Tirzepatide for Recovery and Alcohol Use Management
This is a pilot, 4-week, double-blind, placebo-controlled, randomized trial of individuals with alcohol use disorder (AUD) to receive weekly injections of ...
Tirzepatide reduces alcohol drinking and relapse ... - PubMed
Findings: First, tirzepatide effectively attenuated the rewarding properties of alcohol, measured through locomotor stimulation, conditioned ...
7.
gastroenterologyadvisor.com
gastroenterologyadvisor.com/news/tirzepatide-semaglutide-reduce-alcohol-use-disorder-risk-in-type-2-diabetes/Tirzepatide, Semaglutide Reduce Alcohol Use Disorder ...
Tirzepatide, semaglutide, and liraglutide vs DPP4i were associated with lower risk of alcohol use disorder, especially among men and younger ...
Tirzepatide s Dopaminergic Effects in Alcohol Use ...
A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes.
Can a weight loss drug reduce alcohol cravings
Tirzepatide consistently reduced alcohol consumption and dampened its pleasurable effects. It lowered behavioral responses and blocked dopamine ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.