# What does the research actually show?

Four studies of semaglutide and drinking, each with sample size, effect versus placebo, and limitations — including one Phase 2 trial that missed its primary endpoint.

Every effect below is reported against its comparator, with sample size and limitations.

## Klausen MK, et al. The Lancet, May 2, 2026. doi:10.1016/S0140-6736(26)00305-3

- Design: Randomized, double-blind, 26 weeks, semaglutide 2.4 mg weekly vs placebo; every participant in every arm also received cognitive behavioural therapy.
- Sample: 108 treatment-seeking adults with alcohol use disorder and comorbid obesity (BMI 30+). 81% completed.
- Findings vs comparator: Heavy drinking days fell 41.1 percentage points from baseline versus 26.4 percentage points on placebo — a 13.7-percentage-point difference versus placebo (95% CI −22.0 to −5.4; P=0.0015). Weight loss 11.2 kg versus 2.2 kg on placebo. Number needed to treat 4.3.
- Limitation: Single-centre, obesity-only cohort, and not tested as a standalone therapy since every arm received CBT.

## Cai M, Choi T, Xie Y, Al-Aly Z. BMJ. 2026;392:e086886. doi:10.1136/bmj-2025-086886 (PMID 41781010)

- Design: Observational cohort study of health records.
- Sample: 606,434 US veterans with type 2 diabetes.
- Findings vs comparator: GLP-1 use was associated with a 14% lower risk of developing any substance use disorder, and 18% lower risk for alcohol specifically, compared with non-users.
- Limitation: Observational — association, not causation. Cohort was largely older and male. VA-funded.

## Schacht JP, Sakai JT, Raymond K, Shelton R. American Journal of Psychiatry, July 29, 2026. doi:10.1176/appi.ajp.20260003

- Design: Phase 2 randomized trial, oral semaglutide, 8 weeks.
- Sample: 50 adults.
- Findings vs comparator: This trial MISSED ITS PRIMARY ENDPOINT: a laboratory measure of cue-elicited craving showed no significant difference from placebo. It also missed one of two key secondary endpoints. It did reduce heavy drinking days, drinks per drinking day, and real-world craving compared with placebo.
- Limitation: Primary endpoint not met, so the trial does not establish an effect on cue-elicited craving. Small and short.

## Hendershot CS, Bremmer MP, Paladino MB, et al. JAMA Psychiatry. 2025;82(4):395-405.

- Design: Randomized trial, low-dose semaglutide, 9 weeks.
- Sample: 48 adults.
- Findings vs comparator: Reduced laboratory alcohol consumption and weekly craving compared with placebo.
- Limitation: Very small and very short.

## What is actually approved today

- Semaglutide is NOT FDA-approved to treat alcohol use disorder. It is approved for type 2 diabetes and chronic weight management only.
- There has been no newly FDA-approved medication for alcohol use disorder since 2006. Three medications are approved: naltrexone, acamprosate, and disulfiram.
- A Phase 3 trial exists precisely because the answer is not yet known. Randomized placebo-controlled trials require clinical equipoise — documented genuine uncertainty about which arm is better.

## Sources

- ClinicalTrials.gov, study record NCT07218354 — https://clinicaltrials.gov/study/NCT07218354
- National Institute on Alcohol Abuse and Alcoholism, alcohol use disorder overview — https://www.niaaa.nih.gov/alcohol-health/overview-alcohol-consumption/alcohol-use-disorders
- Klausen MK, et al. The Lancet, May 2, 2026 (doi:10.1016/S0140-6736(26)00305-3) — https://doi.org/10.1016/S0140-6736(26)00305-3
- Cai M, et al. BMJ 2026;392:e086886 (doi:10.1136/bmj-2025-086886) — https://doi.org/10.1136/bmj-2025-086886
- Schacht JP, et al. American Journal of Psychiatry, July 29, 2026 (doi:10.1176/appi.ajp.20260003) — https://doi.org/10.1176/appi.ajp.20260003
- Hendershot CS, et al. JAMA Psychiatry. 2025;82(4):395-405 (doi:10.1001/jamapsychiatry.2024.4789) — https://doi.org/10.1001/jamapsychiatry.2024.4789

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Canonical: https://cravetrial.com/evidence
Author: Jason Burns, Editorial Steward — https://cravetrial.com/steward
Published: 2026-08-05T07:30:00-07:00
Modified: 2026-08-06T10:05:00-07:00
Last verified: 2026-08-06
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