Alcohol Use Disorder, Weight Loss, Bariatric Surgery Patients
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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).
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Post-treatment and six-month follow-up assessments will be completed by a study clinician that is blind to treatment group.
Intervention model description
Participants will be randomized to a medication (Semaglutide) or a wait-list control for three months with a subsequent six-month follow-up (total 9 months).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 9 months: 3-month treatment plus 6-month follow up) * Age 18 and older * Have a BMI ≥30 (or BMI ≥27 with a medical comorbidity) and BMI ≤50 kg/m2 * Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy within the past three years * Meet current DSM-5 criteria for Alcohol Use Disorder * Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators * Read, comprehend, and write English at a sufficient level to complete study-related materials * For females of reproductive potential: use of highly effective contraception and agreement to use such a method during study participation
Exclusion criteria
* 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 * Is currently using other medications for weight loss or other GLP-1 receptor agonists * Has a history of allergy or sensitivity to Semaglutide * Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression) * Has untreated hypertension with a seated systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg, or heart rate \> 100 beats/minute * Has current uncontrolled hypertension * Has current uncontrolled Type I or Type II diabetes mellitus * Has untreated hypothyroidism with a TSH \> 1.5 times the upper limit of normal for the test laboratory with repeat value that also exceeds this limit * Has active gallbladder disease * Has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder * Has a recent history of substance use disorder (with the exception of cannabis or tobacco use disorder) within the past 12 months * Is currently engaging in other treatment for Alcohol Use Disorder or making intentional efforts to quit alcohol use * Is currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device * Is breast-feeding, pregnant, or not using a reliable form of birth control * Reports active suicidal or homicidal ideation * Any disorder, unwillingness or inability, not covered by any of the other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent weight change | Baseline, Week 12, 6-month follow-up | Percent weight change will be calculated. Negative values are indicative of weight loss. Positive values are indicative of weight gain. |
| Mean drinks per calendar day to assess alcohol use | Baseline, Week 4, Week 8, Week 12, 6-month follow-up | Mean drinks per calendar day will be assessed through timeline follow back interviews |
| Mean drinks per drinking day to assess Alcohol use | Baseline, Week 4, Week 8, Week 12, 6-month follow-up | Mean drinks per drinking day will be assessed through timeline follow back interviews |
| Mean number of heavy drinking days to assess Alcohol use | Baseline, Week 4, Week 8, Week 12, 6-month follow-up | Mean number of heavy drinking days will be assessed through timeline follow back interviews |
| Mean number of drinking vs abstinent days to assess Alcohol use | Baseline, Week 4, Week 8, Week 12, 6-month follow-up | Mean number of drinking vs abstinent days will be assessed through timeline follow back interviews |
Countries
United States
Contacts
CONTACTValentina Ivezaj, PhD
CONTACTCaitlin Smith, PhD
PRINCIPAL_INVESTIGATORValentina Ivezaj, PhD
Yale University
Outcome results
None listed