Alcohol Use Disorder study: Semaglutide
Official title Semaglutide Dose Effects on Metabolic and Stress Hormone, Craving and Alcohol Use Outcomes
ClinicalTrials.gov ID: NCT07772960
What this study is testing
What is Semaglutide 1.0 mg?
Semaglutide 1.0 mg is an investigational medicine, being studied as a potential treatment for alcohol use disorder (aud).
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
- This study will examine two doses of 1.0 mg and 2.0 mg of Semaglutide versus placebo in patients with Alcohol Use Disorder (AUD) and Obesity (Ob) to assess if these doses improve alcohol craving, stress and alcohol use outcomes.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, 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 to 68
You may be able to join if
- Male and females ages 18-60 and BMI in 30-49.9 kg/m2;
- regular weekly alcohol use (at least 3X/week) prior to admission;
- must meet current DSM-V criteria for moderate to severe Alcohol Use Disorders (AUDs) using SCID-I for DSM-V;
- Good health as verified by screening and physical examination;
- Able to read English and complete study evaluation;
You likely can't join if
- Meet current criteria for moderate to severe substance use disorders from abuse of any another psychoactive substance, excluding nicotine;
- Current use of opiates;
- Current use of psychiatric medications, including benzodiazepine-based sedatives/anxiolytics and anticonvulsants, non SSRI antidepressants, oral...
- Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
- Endocrine or immune disorders, including diagnosis of diabetes (T2D or T1D) by American Diabetes Association (ADA) criteria or a history of HgbA1c...
- Significant underlying medical conditions, including history of pancreatitis, acute kidney injury, medullary thyroid cancer, or MEN syndrome, as well...
See the full eligibility criteria
- Male and females ages 18-60 and BMI in 30-49.9 kg/m2;
- regular weekly alcohol use (at least 3X/week) prior to admission;
- must meet current DSM-V criteria for moderate to severe Alcohol Use Disorders (AUDs) using SCID-I for DSM-V;
- Good health as verified by screening and physical examination;
- Able to read English and complete study evaluation;
- Able to provide informed written and verbal consent.
- Meet current criteria for moderate to severe substance use disorders from abuse of any another psychoactive substance, excluding nicotine;
- Current use of opiates;
- Current use of psychiatric medications, including benzodiazepine-based sedatives/anxiolytics and anticonvulsants, non SSRI antidepressants, oral prescription analgesics (other than non-steroidal anti-inflammatory...
- Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
- Endocrine or immune disorders, including diagnosis of diabetes (T2D or T1D) by American Diabetes Association (ADA) criteria or a history of HgbA1c \>6.5% and on current medications for T2D treatment;
- Significant underlying medical conditions, including history of pancreatitis, acute kidney injury, medullary thyroid cancer, or MEN syndrome, as well as other cerebral, renal, thyroid or cardiac pathology that would...
- Current use of any anti-obesity medications;
- Prior history of bariatric surgery or current intragastric balloon;
- Current participation in structured meal replacement or weight loss program;
- Weight loss of \>=10% over the preceding 6 months;
- Women who are pregnant, nursing or refuse use of reliable form of birth control.
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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 to 68 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New Haven, Connecticut, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.