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Tirzepatide's Effects on Alcohol Use Disorder (AUD)

This study is looking at how a drug called tirzepatide, which is approved for diabetes, might affect the brains of people with Alcohol Use Disorder (AUD). Researchers want to see if tirzepatide can reduce the urge to drink by changing how dopamine, a brain chemical, works. You would receive either tirzepatide or a placebo (an inactive substance) by injection. The study also uses special brain scans (PET/MR or PET/CT) with tracers like [11C]raclopride and [11C]NNC-112 to measure dopamine levels and receptors. The goal is to understand if tirzepatide can change brain activity related to alcohol cravings. This study is currently recruiting 176 participants, including healthy volunteers and individuals with AUD.

Study design
This is an interventional study with 176 planned participants, including healthy volunteers and individuals with AUD. Participants will be blind to whether they receive tirzepatide or a placebo.
What's involved
If you have AUD, you would complete study procedures within 90 days, potentially longer, and have a follow-up phone call about one month after your scans. Healthy volunteers in Part 1 will have 2-3 PET/MRI scans within 60 days.
Compensation
Not stated in the trial record.
Follow-up
Participants with AUD will have a follow-up phone call about one month after imaging scans are complete. Healthy volunteers in Part 1 complete all study procedures within 60 days.

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NCT07559500

Tirzepatide s Dopaminergic Effects in Alcohol Use Disorders (AUD)

Recruiting
PHASE1Ages 21–65InterventionalBasic science
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
~176 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:TirzepatidePlacebo[11C]raclopride plus drug[11C]NNC-112

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over We aim to have each subject (n=5) complete all study procedures within 60 days.
+1 more outcome measured

Conditions

Alcohol Use Disorder (AUD)

Explore related trials

Abnormal eye physiologyAlcohol use disorder

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Nora D Volkow Adler, M.D. · PRINCIPAL_INVESTIGATOR · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Who to contact

Michele-Vera I Yonga, C.R.N.P.
[email protected]
(301) 273-4169
Email the study team

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Eligibility criteria

Exclusion

We are excluding non-English speakers since the study includes questionnaires that are validated for English and only some are available in Spanish. The fMRI paradigms also require that the subject be able to speak, read and comprehend English.
If a subject s breath alcohol (\>0.08%) screen test is positive on days involving imaging (PET/MRI) and NP testing, the procedures will be postponed and rescheduled. We will allow for up to 3 rescheduled study days resulting from positive breath alcohol screens. If subject continues to show up intoxicated they will be withdrawn.
If urine drug screen is positive for THC-COOH a saliva drug screen will be performed and subject may proceed with study day testing procedures if saliva results for THC are negative. If we are unable to perform the saliva drug screen for any reason, the study day procedures will be postponed. If the urine/saliva drug test is positive on the third rescheduled visit, the participant will be withdrawn from the study. Saliva THC is not required for determining eligibility.
If a participants urine drug screen test is positive for cocaine, heroin or methamphetamine after 3 days of rescheduling they will be excluded.

What this trial measures

  • 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.We aim to have each subject (n=5) complete all study procedures within 60 days.

    We will measure dopamine in the brain. Dopamine is a chemical messenger that carries signals between brain cells. It plays a role in human behavior. It is also believed to play a role in addiction. In this study, we will use a combined scanner for PET and MRI to measure dopamine with the stimulant drug methylphenidate. Each scan will be done by getting a small amount of a radiotracer through an IV catheter. During each of the two PET/MRI scan sessions each subject will receive IV methylphenidate. We will look at the effects of methylphenidate on brain dopamine. We will also look at brain responses, mood and thinking. The results of each subject's scans will be compared to each other. We will also compare the results to other participants to see if we get similar information.

  • Part 2 (n=88, 44 healthy volunteers and 44 AUD) : Effects of Tirzepatide on striatal dopamine D1R and D2R availability; striatal DA increase; brain reactivity to MP and to food and alcohol cues in AUD and in healthy controls.We aim to have each subject complete study procedures within 90 days, but this could take longer. AUD participants will undergo a Follow Up phone call about 1 month after imaging scans are complete.

    We will measure dopamine levels in the brain. Dopamine is a chemical messenger that carries signals between brain cells. It plays a role in human behavior. It is also believed to play a role in addiction. In this study, we will use a combined scanner for PET and MRI to measure dopamine with the stimulant drug methylphenidate. We will look at the effects of methylphenidate on brain dopamine. To do this we will obtain imaging scans after the subject receives Tirzepatide and a Placebo. We will also look at brain responses, mood and thinking. Results from the same scans on two separate days will be compared to each other. We will also compare the results to other participants to see if we get similar information.