A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder
This research study is investigating a new medication called brenipatide for individuals dealing with moderate to severe alcohol use disorder. The main goal is to find out if brenipatide is both safe and helpful when compared to a placebo, which is an inactive substance that looks just like the real medication. Participants will be involved for about 56 weeks. This study aims to help those who are motivated to reduce or stop their alcohol consumption. By participating, you would be helping researchers understand if this new treatment could be a valuable option for many people in the future.
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¿De qué trata este estudio?
This study is about a new medicine called brenipatide, and how it might help people who struggle with moderate to severe alcohol use disorder. Alcohol use disorder is a condition where a person has trouble controlling their drinking, even when it causes problems in their life. The researchers want to see if brenipatide can help people cut down or stop drinking, and if it's safe to use.
To find this out, they will compare brenipatide with a 'placebo.' A placebo is a dummy pill or injection that doesn't contain any active medicine. This helps the researchers understand if the changes people experience are truly due to the medicine or something else. Half of the people in the study will get brenipatide, and the other half will get the placebo. Neither you nor your study doctor will know which one you are receiving.
This is a 'Phase 3' study, which means the medicine has already been tested in smaller groups of people and shown some promise. This larger study is needed to confirm its safety and effectiveness before it can potentially be made available to more people. Taking part could help improve treatments for alcohol use disorder.
Puntos clave
- This study is testing a new medicine called brenipatide for alcohol use disorder.
- It aims to see if brenipatide is safe and helps people reduce or stop drinking.
- Participants will receive either brenipatide or a dummy medicine (placebo).
- The study involves regular clinic visits and self-injections of the study medicine.
- Participation lasts about 56 weeks and helps advance understanding of treatments.
- You can withdraw from the study at any time without penalty.
¿Quién puede ser elegible?
You might be able to join this study if you are between 18 and 75 years old and are actively looking for help to stop or reduce your drinking. It's important that you are able to attend all the study visits and follow the instructions carefully throughout the study, which includes things like keeping diaries and giving yourself injections.
However, some things would mean you can't take part. For example, if you've had problems with certain other types of substance use (other than alcohol, nicotine, or caffeine) in the last six months, or if you've had recent thoughts or actions related to harming yourself. Also, if you have severe liver disease, you wouldn't be able to join this study. The study team will check for these and other conditions to make sure the study is safe for you.
¿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.
- ¿Tienes entre 18 y 75 años?
- Are you motivated to cut down or stop your drinking?
- Are you able to attend all study visits and follow instructions carefully?
- Have you had no serious substance use issues (other than alcohol, nicotine, or caffeine) in the last 6 months?
- Have you not had recent thoughts or actions to harm yourself in the last 6 months?
- Do you have no severe liver disease?
¿En qué consiste la participación?
If you join this study, your involvement would last for about 56 weeks, which is just over a year. During this time, you would have regular visits to the study clinic. You would need to give yourself the study medicine (either brenipatide or the placebo) as an injection at home. You'll be shown exactly how to do this safely and how to store the medicine properly.
You'll also be asked to keep track of your progress by filling out electronic or paper diaries and completing questionnaires. These help the study team understand how you are doing. The team will provide you with all the necessary materials and support throughout your participation.
Riesgos y beneficios potenciales
Locations (117)
- Parkway Medical CenterCódigo postal verificadoBirmingham, United States· Completado
- Headlands Research - ScottsdaleCódigo postal verificadoScottsdale, Estados Unidos· Activo, no reclutando
- Woodland International Research GroupCódigo postal verificadoLittle Rock, Estados Unidos· Completado
- UCLA Clinical & Translational Research Center (CTRC)Código postal verificadoLos Angeles, United States· Activo, no reclutando
- Artemis Institute for Clinical ResearchCódigo postal verificadoSan Diego, Estados Unidos· Activo, no reclutando
- UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission BayCódigo postal verificadoSan Francisco, Estados Unidos· Activo, no reclutando
- Mountain Mind - DenverCódigo postal verificadoDenver, Estados Unidos· Activo, no reclutando
- Accel Research Sites - Lakeland Clinical Research UnitCódigo postal verificadoLakeland, United States· Activo, no reclutando
- K2 Medical Research - MaitlandCódigo postal verificadoMaitland, United States· Activo, no reclutando
- K2 Medical Research ORLANDOCódigo postal verificadoMaitland, United States· Activo, no reclutando
- Life Arc Research Centers - MiamiCódigo postal verificadoMiami, United States· Activo, no reclutando
- Wellness Research CenterCódigo postal verificadoMiami, United States· Activo, no reclutando
Preguntas comunes
What is brenipatide?
Brenipatide is a new medication being tested to see if it can help people with moderate to severe alcohol use disorder.
¿Qué es un placebo?
A placebo is a 'dummy' medicine that looks like the real treatment but doesn't contain any active drug. It helps researchers understand if the new medicine is actually working.
¿Cuánto tiempo durará el estudio?
If you join, your participation in the study will last for approximately 56 weeks, which is a little over a year.
¿Sabré si estoy recibiendo el medicamento real o el placebo?
Neither you nor your study doctor will know whether you are receiving brenipatide or the placebo during the study.
¿Puedo abandonar el estudio en cualquier momento?
Sí, eres libre de abandonar el estudio en cualquier momento, y hacerlo no afectará tu atención médica futura.
Cómo obtener más información
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
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Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.