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.
Em resumo
Sobre o que é este estudo?
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.
Pontos principais
- 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.
Quem pode ser elegível?
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.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- Você tem entre 18 e 75 anos?
- 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?
O que envolve a participação?
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.
Riscos e benefícios potenciais
Locations (117)
- Parkway Medical CenterCódigo postal verificadoBirmingham, Estados Unidos· Concluído
- Headlands Research - ScottsdaleCódigo postal verificadoScottsdale, Estados Unidos· Ativo, mas não recrutando
- Woodland International Research GroupCódigo postal verificadoLittle Rock, Estados Unidos· Concluído
- UCLA Clinical & Translational Research Center (CTRC)Código postal verificadoLos Angeles, Estados Unidos· Ativo, mas não recrutando
- Artemis Institute for Clinical ResearchCódigo postal verificadoSan Diego, Estados Unidos· Ativo, mas não recrutando
- UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission BayCódigo postal verificadoSão Francisco, Estados Unidos· Ativo, mas não recrutando
- Mountain Mind - DenverCódigo postal verificadoDenver, Estados Unidos· Ativo, mas não recrutando
- Accel Research Sites - Lakeland Clinical Research UnitCódigo postal verificadoLakeland, United States· Ativo, mas não recrutando
- K2 Medical Research - MaitlandCódigo postal verificadoMaitland, United States· Ativo, mas não recrutando
- K2 Medical Research ORLANDOCódigo postal verificadoMaitland, United States· Ativo, mas não recrutando
- Life Arc Research Centers - MiamiCódigo postal verificadoMiami, Estados Unidos· Ativo, mas não recrutando
- Wellness Research CenterCódigo postal verificadoMiami, Estados Unidos· Ativo, mas não recrutando
Perguntas frequentes
What is brenipatide?
Brenipatide is a new medication being tested to see if it can help people with moderate to severe alcohol use disorder.
O que é um 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.
Quanto tempo durará o estudo?
If you join, your participation in the study will last for approximately 56 weeks, which is a little over a year.
Saberei se estou recebendo o medicamento real ou o placebo?
Neither you nor your study doctor will know whether you are receiving brenipatide or the placebo during the study.
Posso sair do estudo a qualquer momento?
Yes, you are free to leave the study at any point, and doing so will not affect your future medical care.
Como saber mais
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.
Interessado em participar?
Discussão
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Desenvolvido pelo nosso fórum em community.patient.info. Por favor, seja respeitoso — isto não é um conselho médico.