A Study of Brenipatide in Participants With Alcohol Use Disorder
This research study is investigating a new potential treatment, brenipatide, for individuals who have alcohol use disorder (AUD) and drink at hazardous levels. The main goal is to find out if brenipatide is both safe to use and effective in helping people reduce or stop drinking, compared to a placebo (a dummy treatment). Participants will be involved in the study for about 56 weeks, which is just over a year. Throughout this time, researchers will closely monitor their health and drinking habits to understand how well the new medication works and if there are any side effects. Your participation would help us learn more about potential new ways to treat AUD.
Em resumo
Sobre o que é este estudo?
This study is all about finding a new and effective way to help people who are struggling with alcohol use disorder, sometimes called AUD. AUD is a medical condition where a person has problems controlling their drinking, is preoccupied with alcohol, or continues to use alcohol even when it causes problems. The new medication being tested in this study is called brenipatide.
Researchers want to compare brenipatide to a placebo. A placebo looks just like the actual medication but doesn't contain any active drug. This comparison helps scientists understand if any changes seen are truly due to brenipatide or if they might happen anyway. It's a standard and important part of medical research to make sure new treatments are genuinely effective.
By taking part, you would be contributing to vital research that could one day lead to more options for people living with alcohol use disorder. The study will look carefully at whether brenipatide helps people reduce or stop their drinking and if it's safe to use over time.
Pontos principais
- The study tests a new drug, brenipatide, for alcohol use disorder.
- It compares brenipatide to a placebo (dummy treatment).
- Participation lasts about 56 weeks (over a year).
- You'll need to self-inject the medication or have help.
- Close medical monitoring and regular visits are part of the study.
- Your involvement helps advance treatments for alcohol use disorder.
Quem pode ser elegível?
To join this study, you need to be between 18 and 75 years old. If you're in Japan, you need to be at least 20. It's important that you are actively looking for help with your drinking and are motivated to either stop or cut down.
You can't take part if you've recently had problems with other drug use (apart from nicotine or caffeine) within the last six months. Also, if you've had certain thoughts about self-harm or suicide recently, or have a history of serious liver disease related to alcohol, this study might not be suitable for you. You also shouldn't have taken part in another drug study within a certain recent timeframe.
Overall, the study is looking for people who are committed to attending appointments, willing to follow instructions, and can manage self-injecting the study medication (or have someone to help them).
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.
- Are you between 18 and 75 years old (or 20+ if in Japan)?
- Are you motivated to stop or cut down your drinking?
- Can you commit to around 56 weeks for the study?
- Will you be able to give yourself injections or have someone help you?
- Do you have certain serious liver conditions or recent drug use issues (excluding nicotine/caffeine)? (If yes to these, you might not be eligible).
- Have you recently had specific thoughts about self-harm or suicide? (If yes, you might not be eligible).
O que envolve a participação?
If you join this study, your involvement will last for about 56 weeks, which is just over a year. During this time, you would have regular visits to the study clinic where you'll have health checks and discussions about your progress. You will also need to self-inject the study medication – either brenipatide or the placebo – at home. If you're unable to do this yourself, someone trained can help you.
You'll also be asked to keep track of your information in diaries, either on paper or electronically, and complete questionnaires. These help the researchers understand how you're feeling and how the treatment is working. Throughout the study, your health will be carefully monitored to check for any side effects and to see the effects of the treatment.
Riscos e benefícios potenciais
Locations (116)
- Headlands Research - ScottsdaleCódigo postal verificadoScottsdale, Estados Unidos· Ativo, mas não recrutando
- Woodland International Research GroupCódigo postal verificadoLittle Rock, Estados Unidos· Ativo, mas não recrutando
- UCLA Clinical & Translational Research Center (CTRC)Código postal verificadoLos Angeles, Estados Unidos· Ativo, mas não recrutando
- Artemis Institute for Clinical ResearchCódigo postal verificadoRiverside, 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
- Accel Research Sites - Lakeland Clinical Research UnitCódigo postal verificadoLakeland, United States· Ativo, mas não recrutando
- Innovative Clinical ResearchCódigo postal verificadoLauderhill, 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 alcohol use disorder reduce or stop their drinking.
O que é um placebo?
A placebo is a 'dummy' treatment that looks just like the real medication but doesn't contain any active drug. It helps researchers compare the new treatment's effects.
Quanto tempo estarei no estudo?
If you join, you will be part of the study for about 56 weeks, which is roughly one year and two months.
Will I know if I'm getting the real medication or the placebo?
No, you won't know if you're receiving brenipatide or the placebo. This is to ensure fair results for the study.
Posso parar de participar do estudo a qualquer momento?
Yes, you are free to leave the study at any point and for any reason, without it affecting your regular 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.