RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Semaglutide 1.0 mg for Alcohol Use Disorder (AUD)

This study will examine two doses of 1.0 mg and 2.0 mg of Semaglutide versus dummy treatment (placebo) in patients with Alcohol Use Disorder (AUD) and Obesity (Ob) to assess if these doses improve alcohol craving, stress and alcohol use outcomes.

Official registry: https://clinicaltrials.gov/study/NCT07772960 · Yale University · enrollment listed as 90

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 Placebo, Semaglutide 1.0 mg, or Semaglutide 2.0 mg. The registry lists allocation as randomized. This study will examine two doses of 1.0 mg and 2.0 mg of Semaglutide versus dummy treatment (placebo) in patients with Alcohol Use Disorder (AUD) and Obesity (Ob) to assess if these doses improve alcohol craving, stress and alcohol use outcomes.

They plan to enroll about 90 people at New Haven. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Semaglutide Dose Effects on Metabolic and Stress Hormone, Craving and Alcohol Use Outcomes

Interventions: Placebo, Semaglutide 1.0 mg, Semaglutide 2.0 mg

Primary outcome (registry wording): Alcohol use days

Who it is for (from inclusion criteria)

Ages 18 Years to 68 Years
Male and females ages 18-60 and body-mass index (BMI) in 30-49.9 kg/m2;
regular weekly alcohol use (at least 3X/week) prior to admission;
must meet current DSM-V criteria for moderate to severe Alcohol Use Disorders (AUDs) using SCID-I for DSM-V;
Good health as verified by screening and physical examination;
Able to read English and complete study evaluation;

Who the registry excludes

Meet current criteria for moderate to severe substance use disorders from abuse of any another psychoactive substance, excluding nicotine;
Current use of opiates;
Current use of psychiatric medications, including benzodiazepine-based sedatives/anxiolytics and anticonvulsants, non SSRI antidepressants, oral prescription analgesics (other than non-steroidal anti-inflammatory drugs), acamprosate, naltrexone, antabuse, baclofen, varenicline;
Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
Endocrine or immune disorders, including diagnosis of diabetes (T2D or T1D) by American Diabetes Association (ADA) criteria or a history of HgbA1c \>6.5% and on current medications for T2D treatment;
Significant underlying medical conditions, including history of pancreatitis, acute kidney injury, medullary thyroid cancer, or MEN syndrome, as well as other cerebral, renal, thyroid or cardiac pathology that would preclude study participation;
Current use of any anti-obesity medications;

Public study contact (from the registry)

RAJITA SINHA, PHD

2037375805

rajita.sinha@yale.edu

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

Sites listed on ClinicalTrials.gov

1 listed

Yale Stress Center — New Haven, Connecticut (recruiting)

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FAQ about this NCT record

Is NCT07772960 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 NCT07772960?

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 NCT07772960?

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