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NCT07559500 · ClinicalTrials.gov registry record · Phase 1
Tirzepatide s Dopaminergic Effects in Alcohol Use Disorders (AUD)
A Phase 1 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 176
- Enrollment target
NCT07559500 is a Phase 1 study that is actively recruiting participants, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 176 participants.
The verdict
NCT07559500, a Phase 1 study, is actively recruiting participants, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 176 participants
- Enrollment target
Study Summary
Background: Glucagon-like peptide 1 (GLP-1) agonist drugs are used to treat diabetes and aid weight loss. They may also help reduce cravings for drugs and alcohol. Researchers want to know if a GLP-1 drug (tirzepatide) can lessen the urge to drink in people with alcohol use disorder (AUD). Objective: To learn how the brains of people with AUD respond to a GLP-1 drug. Eligibility: People aged 21 to 65 years with AUD who are non-treatment seeking. They must be enrolled in protocol 14-AA-0181. Healthy volunteers are also needed. Design: This study consists of Part 1 and Part 2. Part 1 (Imaging Procedures): Five healthy volunteers will undergo 2 to 3 combined positron emission tomography/magnetic resonance imaging (PET/MRI) scans, with an interval of 2 to 3 weeks between scans. For each scan, a radioactive substance (tracer) will be administered intravenously. Participants will undergo PET/MRI scanning to assess brain activity during resting state. Methylphenidate (Ritalin) will be administered during each scan. Each imaging session will last approximately 2 hours. Tirzepatide and placebo will not be administered in Part 1. Participants with alcohol use disorder (AUD) are not included in Part 1. The purpose of this part of the study is to assess test/retest reproducibility of the PET/MRI combined scan measures. Part 2 (Randomization to Tirzepatide \& Placebo): Participants will be randomized to receive either Tirzepatide or Placebo first. Healthy Volunteers and AUD participants will receive both treatments in a crossover design. Tirzepatide and placebo will be administered via subcutaneous injection (under the skin) once weekly for 2 to 3 weeks. This treatment period will be followed by 2 to 3 PET/MRI combined imaging scans described in the next paragraph. After a washout interval of approximately 2 to 3 weeks, participants will cross over to the alternate treatment (tirzepatide or placebo), administered once weekly for 2 to 3 weeks. This second treatment perio
Interventions
- DRUG Placebo
- DRUG Tirzepatide
- DRUG [11C]raclopride plus drug
- DRUG [11C]NNC-112
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2026-05-20 |
| Est. Completion | 2031-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07559500
The ClinicalTrials.gov registry entry for NCT07559500 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 176 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT07559500 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07559500 about?
NCT07559500 is a clinical study titled "Tirzepatide s Dopaminergic Effects in Alcohol Use Disorders (AUD)". Background: Glucagon-like peptide 1 (GLP-1) agonist drugs are used to treat diabetes and aid weight loss. They may also help reduce cravings for drugs and alcohol. Researchers want to know if a GLP-1 drug (tirzepatide) can lessen the urge to drink in people with alcohol use disorder (AUD). Objecti...
What is the current status of trial NCT07559500?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 176 participants. The study started on 2026-05-20. Estimated completion is 2031-12-31.
What interventions are being tested in trial NCT07559500?
The interventions under investigation include: Placebo (DRUG), Tirzepatide (DRUG), [11C]raclopride plus drug (DRUG), [11C]NNC-112 (DRUG).
Who is sponsoring clinical trial NCT07559500?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
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