RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Tirzepatide for Alcohol Use Disorder (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.

Official registry: https://clinicaltrials.gov/study/NCT07559500 · National Institute on Alcohol Abuse and Alcoholism (NIAAA) · enrollment listed as 176

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Tirzepatide, Placebo, or [11C]raclopride plus drug. The registry lists allocation as randomized. Background: Glucagon-like peptide 1 (GLP-1) agonist drugs are used to treat diabetes and aid weight loss.

They plan to enroll about 176 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Tirzepatide s Dopaminergic Effects in Alcohol Use Disorders (AUD), a Phase 1b Study

Interventions: Tirzepatide, Placebo, [11C]raclopride plus drug, [11C]NNC-112

Primary outcome (registry wording): Part 1 (n=5 healthy volunteers): We will assess the reproducibility of striatal dopamine (DA) measures in response to iv methylphenidate (MP) using PET/MR combined scanning and the bolus infusion protocol in healthy controls.

Who it is for (from inclusion criteria)

Ages 21 Years to 65 Years
Healthy Volunteer Participants
To be eligible to participate in this study, an individual must meet the following criteria:
Enrollment in 14AA0181
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, ages 21-65 years old
Have or had any prior experience with stimulant drugs including cocaine, methylphenidate, amphetamine or methamphetamine, or prescription stimulants (prescription or recreational use), whether or not they have had a past substance use disorder
To be eligible, individuals with AUD must meet the following criteria:

Who the registry excludes

All Participants (Healthy Volunteers and AUD)
Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard contraindication to MRI
Cannot lie comfortably flat on his/her back for up to 2 hours in the PET/MRI scanner
body-mass index (BMI) \<23 or \>35 (but no more than 500 lbs). The PET/MRI scanner bed is tested to a weight limit of 500 lbs
Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that, with the exposure from this study, would exceed NIH annual research limits as determined by medical history and physical exam
Severe head trauma with loss of consciousness \> 60 minutes
Current severe mental illness (schizophrenia, bipolar disorder)

Public study contact (from the registry)

Michele-Vera I Yonga, C.R.N.P.

(301) 273-4169

michele-vera.yonga@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

National Institutes of Health Clinical Center — Bethesda, Maryland (recruiting)

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FAQ about this NCT record

Is NCT07559500 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07559500?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07559500?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary