Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This study aims to evaluate the feasibility and acceptability of treating Alcohol Use Disorder with Semaglutide after metabolic and bariatric surgery in adults with overweight/obesity. This study will also examine changes in alcohol use disorder and weight. It is hypothesized that the treatment will be feasible and acceptable to participants, and result in reductions in alcohol use and weight.
A recently published randomized controlled trial provided preliminary evidence that Semaglutide can reduce some alcohol craving and drinking outcomes; however, this has not been examined in individuals with a history of bariatric surgery who are at increased risk of alcohol misuse and Alcohol Use Disorder.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Experimental | Participants 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. Participants will be on Semaglutide for three months total. |
|
| Wait-list control | No Intervention | Participants randomized to wait-list control will be followed for three months but no treatment will be administered. At the conclusion of the study, participants in the wait list control group will be offered a three-month behavioral intervention to treat Alcohol Use Disorder, although this is not required. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide 1.0 mg | Drug | Participants 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Percent weight change | Percent weight change will be calculated. Negative values are indicative of weight loss. Positive values are indicative of weight gain. | Baseline, Week 12, 6-month follow-up |
| Mean drinks per calendar day to assess alcohol use | Mean drinks per calendar day will be assessed through timeline follow back interviews | Baseline, Week 4, Week 8, Week 12, 6-month follow-up |
| Mean drinks per drinking day to assess Alcohol use | Mean drinks per drinking day will be assessed through timeline follow back interviews | Baseline, Week 4, Week 8, Week 12, 6-month follow-up |
| Mean number of heavy drinking days to assess Alcohol use | Mean number of heavy drinking days will be assessed through timeline follow back interviews | Baseline, Week 4, Week 8, Week 12, 6-month follow-up |
| Mean number of drinking vs abstinent days to assess Alcohol use | Mean number of drinking vs abstinent days will be assessed through timeline follow back interviews | Baseline, Week 4, Week 8, Week 12, 6-month follow-up |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valentina Ivezaj, PhD | Contact | 203-785-7807 | valentina.ivezaj@yale.edu | |
| Caitlin Smith, PhD | Contact | 203-785-7210 | caitlin.smith@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Valentina Ivezaj, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | Recruiting | New Haven | Connecticut | 06520 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39937469 | Background | Hendershot CS, Bremmer MP, Paladino MB, Kostantinis G, Gilmore TA, Sullivan NR, Tow AC, Dermody SS, Prince MA, Jordan R, McKee SA, Fletcher PJ, Claus ED, Klein KR. Once-Weekly Semaglutide in Adults With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Apr 1;82(4):395-405. doi: 10.1001/jamapsychiatry.2024.4789. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591245 | semaglutide |
Not provided
Not provided
Not provided
Participants will be randomized to a medication (Semaglutide) or a wait-list control for three months with a subsequent three-month follow-up (total 6 months).
Not provided
Not provided
Post-treatment and six-month follow-up assessments will be completed by a study clinician that is blind to treatment group.
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |