Semaglutide Therapy for Alcohol Reduction - Tulsa

What Was Tested

The trial (phase 2) is built around Semaglutide.

It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).

Participants will receive subcutaneous injections of a placebo saline solution over the course of 12 weeks.

The registry classes the interventions as drug.

More on the Plan

Participants will complete a remote phone screening and an on-site screening visit to determine study eligibility.

Eligible participants will be randomized to receive weekly subcutaneous injections of either semaglutide or a placebo (1:1 ratio).

Participants will be asked to complete experimental procedures at the baseline and endpoint visits (Week 1 and Week 12), which include functional magnetic resonance imaging (fMRI) experiments, functional near-infrared spectroscopy (fNIRS) experiments, and virtual reality experiments.

Participants will also complete questionnaires, biospecimen collections, and computer-based behavioral therapy modules at various study timepoints.

Who Took Part

The registry lists 80 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ability to provide informed consent before any trial-related activities. Male or female individuals who are at least 18 years old. Able to speak, read, write, and understand English. Normal or corrected-to-normal (e.g., wearing glasses or contacts) vision and normal or corrected-to-normal (e.g., with the use of a hearing aid) hearing.

The full record lists 8 inclusion and 21 exclusion criteria; among the exclusions: BMI \< 25 kg/m2 or BMI ≥ 50 kg/m2; evidence of malnutrition as determined by the nutrition risk screening 2002 (nrs-2002); current use of the following medications with glucose lowering properties: glp-1 analogues, sulfonylurea, insulin, metformin, thiazolidinediones (tzd), dipeptidyl peptidase-4 (dpp-iv) inhibitors, sodium-glucose cotransporter-2 (sglt-2) inhibitors.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

The Semaglutide group and the comparison group ran side by side rather than switching.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2023-07-07 with completion listed for 2025-07-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in alcohol drinks per drinking day (time frame: Baseline (Week 1) to post-medication (Week 13)).

It also tracked 8 secondary outcomes, for example Change in drinks per week, Change in heavy drinking days per week, Safety and tolerability of semaglutide in individuals with alcohol use disorder (AUD), Change in blood phosphatidylethanol (PEth) levels as a biomarker of alcohol use, Changes in brain activity in response to alcohol cues during fMRI cue reactivity task and Changes in brain activity during an fMRI interoceptive attention task.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 80 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.