Clinical Trial of Rybelsus (Semaglutide) Among Adults With Alcohol Use Disorder (AUD)

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05892432
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide 3 MG [Rybelsus] — DRUG
    Semaglutide 3 mg will be taken for the first 4 weeks of the 8-week trial.
  • Semaglutide 7 MG [Rybelsus] — DRUG
    Semaglutide 7 mg will be taken for the second 4 weeks of the 8-week trial.
  • Placebo — DRUG
    A medically inert placebo medication will be taken for 8 weeks.

Study Details

This study is a randomized controlled trial of oral semaglutide among treatment-seeking individuals with AUD. The investigators will randomly assign 50 participants to receive semaglutide (titrated to 7 milligrams (mg) per day) or matched placebo for 8 weeks. The primary aims are to assess the safety and tolerability of semaglutide in this population and to evaluate its effects, relative to placebo, on alcohol cue-elicited craving and alcohol consumption.

Key Dates

Start date
Jan 11, 2024
Status verified
Dec 2025
Primary completion
Nov 4, 2025
Completion
Nov 15, 2025

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Participants in this Arm will take a medically inert placebo. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the capsule orally each morning.
  • Active Comparator: Semaglutide 3 milligrams and 7 milligrams
    Participants in this Arm will study medication for a total of 8 weeks - on semaglutide 3 milligrams per day for 4 weeks, then 7 milligrams per day for 4 weeks. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the capsule orally each morning.

Primary Outcome Measure

Change in Cue Craving Visual Analog Score [ Time Frame: 7 weeks - change between screening and Week 6 visit ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045-

Find similar trials in Aurora, CO

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
University of Colorado Anschutz Medical Campus· Aurora, CO

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