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Does the Glucagon-like Peptide 1 (GLP-1) receptor agonist semaglutide reduce alcohol intake in patients with Alcohol Use Disorder and comorbid obesity?

This research is investigating if a medication known as semaglutide, typically used for managing diabetes and helping with weight loss, could be effective in reducing alcohol consumption for individuals who struggle with alcohol use disorder and also have obesity. It's a phase II study, meaning it's an early step to explore if the treatment has a promising effect before larger studies are conducted. Participants will either receive semaglutide or a dummy treatment (saline injection) for 26 weeks. The main goal is to see if semaglutide can reduce the number of days someone drinks heavily over a 30-day period. Researchers will also look at other factors like overall alcohol intake, craving levels, and general health changes.

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Estado
Reclutamiento
Fase
Exploratorio terapéutico (Fase II)
Patrocinador
Region Hovedstaden
Objetivo de inscripción
108
Inicio
12 May 2023

¿De qué trata este estudio?

This study is designed to explore a new potential use for a medicine called semaglutide. You might know semaglutide by brand names like Wegovy, and it's currently approved to help people manage type 2 diabetes and, more recently, to aid with weight loss. However, scientists are now wondering if it could also help individuals who struggle with alcohol use disorder and who also happen to be overweight or obese.

The main idea behind this research is to see if semaglutide can help people reduce the amount of alcohol they drink, particularly the number of days they drink heavily. They will compare semaglutide to a 'dummy' injection (called a placebo or saline) to understand if any changes are truly due to the active medicine or if they might happen anyway. This is a "Phase II" study, which means it’s an early exploratory step to figure out if the treatment shows enough promise to move forward with larger, more comprehensive studies in the future.

Over 26 weeks, researchers will closely monitor participants' drinking habits. They'll also look at a range of other health markers, including changes in weight, blood pressure, and how strong their cravings for alcohol might be. They even plan to use special brain scans to see if semaglutide affects brain activity related to alcohol. All of this information will help them understand if semaglutide could become a helpful tool for some people dealing with alcohol use disorder.

Puntos clave

  • This study explores if semaglutide can help reduce alcohol intake in people with alcohol use disorder and obesity.
  • It's an early-stage (Phase II) research study.
  • Participants will receive either semaglutide or a dummy injection for 26 weeks.
  • Researchers will monitor alcohol consumption, body weight, and other health markers.
  • It aims to see if this medicine could be a new treatment option in the future.

¿Quién puede ser elegible?

To join this study, you need to be an adult, at least 18 years old. Both men and women can take part. The study is specifically looking for people who have been diagnosed with alcohol use disorder and also have obesity. This means you would need to meet certain medical criteria for both conditions.

There will be specific health checks and other requirements that the study doctors will go over with you. These are in place to make sure the study is safe for you and that the results are as clear as possible. Things like other existing health conditions or medicines you are taking might affect whether you can join.

¿Podría este estudio ser adecuado para ti?

Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.

  1. ¿Tienes 18 años o más?
  2. Have you been diagnosed with Alcohol Use Disorder?
  3. Have you also been diagnosed with obesity?
  4. Are you able to attend regular clinic visits for about six months?
  5. Are you willing to receive injections (either the medicine or a dummy one)?
Responde cada pregunta para ver tu resultado.

¿En qué consiste la participación?

If you decide to participate, you would be randomly assigned to one of two groups: either receiving the study medicine, semaglutide, or a 'dummy' injection called saline. You wouldn't know which one you are getting. Both are given as an injection under the skin using a pre-filled pen. The treatment period would last for 26 weeks, which is about six months.

Throughout the study, you would attend regular visits to the clinic. During these visits, the research team would assess your alcohol consumption using specific methods, monitor your general health, take blood samples, and perhaps conduct other tests like brain scans. They will be looking at how your drinking patterns change, how you feel, and any effects the treatment might have on your body. After the 26-week treatment, there might be a follow-up period to see how you are doing.

Riesgos y beneficios potenciales

Participating in a clinical trial could potentially offer an early opportunity to try a new treatment that might help with alcohol use disorder. However, there are no guarantees that you will experience any direct benefits. The medicine, semaglutide, may also have side effects, which the study team will explain in detail. Potential risks could include injection site reactions, stomach upset, or other side effects known with semaglutide. You are free to withdraw from the study at any time, for any reason, without affecting your medical care.

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Preguntas comunes

What is 'Alcohol Use Disorder'?

Alcohol Use Disorder (AUD) is a medical condition where a person has trouble controlling their drinking, is preoccupied with alcohol, or continues to drink even when it causes problems.

What is semaglutide (Wegovy)?

Semaglutide is a medicine usually prescribed for type 2 diabetes and weight management. It works by affecting hormones that control appetite and blood sugar.

What does 'Phase II' mean for a study?

A Phase II study is an early stage of research. It's done to see if a new treatment works and if it's safe enough to continue with larger studies.

What is a 'dummy' injection (saline)?

A dummy injection, or placebo, looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the actual medicine fairly.

Will I know if I'm getting the medicine or the dummy injection?

No, in this type of study, neither you nor the study team will know which treatment you are receiving until the study is over. This is to ensure fair results.

Cómo obtener más información

Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.

¿Interesado en participar?

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