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New treatment option for Alcohol Use Disorder
Official title Semaglutide (SEMA) for Alcohol Use Disorder (AUD) After Metabolic and Bariatric Surgery (MBS)
ClinicalTrials.gov ID: NCT07223983
What this study is testing
What is Semaglutide 1.0 mg?
Semaglutide 1.0 mg is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for alcohol use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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 seven years
You likely can't join if
- Any of the following: myocardial infarction, stroke, hospitalization for unstable angina, or transient ischemic attack within the past 60 days prior...
- 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
See the full eligibility 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 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
- Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy within the past seven 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
- 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 exclusion criteria which, in the investigator's opinion, might have jeopardized the participant's safety or compliance with the protocol
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.