Semaglutide (SEMA) for Alcohol Use Disorder (AUD) After Metabolic and Bariatric Surgery (MBS)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
The purpose of this research study is to evaluate the feasibility of treating Alcohol Use Disorder with Semaglutide after metabolic and bariatric surgery in adults with overweight or obesity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study (up to 6 months: 3-month treatment plus 3-month follow up)
Age 18 and older
Have a BMI ≥30 (or BMI ≥27 with a medical comorbidity) and BMI ≤50 kg/m2
Disqualifiers
Any of the following: myocardial infarction, stroke, hospitalization for unstable angina, or transient ischemic attack within the past 60 days prior to screening
History or presence of chronic or recurrent pancreatitis
History of malignant neoplasms within the past 5 years prior to screening
Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2
Trial design
Design model
Parallel
Treatments tested in this trial
Semaglutide 1.0 mg
DrugParticipants randomized to Semaglutide will be initiated on a 0.25 mg dose (injection) once weekly for 4 weeks (first month) with an escalation to 0.5 mg for the second month, and 1.0 mg in the final month (three months total).
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: SemaglutideExperimental treatment 1 intervention
Group B: Wait-list controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Percent weight change
Percent weight change will be calculated. Negative values are indicative of weight loss. Positive values are indicative of weight gain.
Time frame
Baseline, Week 12, 6-month follow-up2
Mean drinks per calendar day to assess alcohol use
Mean drinks per calendar day will be assessed through timeline follow back interviews
Time frame
Baseline, Week 4, Week 8, Week 12, 6-month follow-up3
Mean drinks per drinking day to assess Alcohol use
Mean drinks per drinking day will be assessed through timeline follow back interviews
Time frame
Baseline, Week 4, Week 8, Week 12, 6-month follow-up4
Mean number of heavy drinking days to assess Alcohol use
Mean number of heavy drinking days will be assessed through timeline follow back interviews
Time frame
Baseline, Week 4, Week 8, Week 12, 6-month follow-upSponsors and contacts
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Source ClinicalTrials.gov