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

Registration

Registration

NCT07559500

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

DOUBLE

Status

RECRUITING

Enrollment

176

Start

2026-05-20

Primary completion

2031-12-31

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Conditions

Alcohol Use Disorder (AUD)

Interventions

DRUG:Tirzepatide; DRUG:Placebo; DRUG:[11C]raclopride plus drug; DRUG:[11C]NNC-112

Results posted

FALSE

Individual participant data sharing

UNDECIDED

Secondary identifiers

OTHER:002447-AA

Registered primary outcomes

• 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.]
• 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.]