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.
Överblick
Vad handlar denna studie om?
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.
Viktiga punkter
- 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.
Vem kan vara berättigad?
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).
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- 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).
Vad innebär deltagande?
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.
Potentiella risker och fördelar
Locations (116)
- Headlands Research - ScottsdaleVerifierat postnummerScottsdale, USA· Aktiv men inte rekryterande
- Woodland International Research GroupVerifierat postnummerLittle Rock, USA· Aktiv men inte rekryterande
- UCLA Clinical & Translational Research Center (CTRC)Verifierat postnummerLos Angeles, USA· Aktiv men inte rekryterande
- Artemis Institute for Clinical ResearchVerifierat postnummerRiverside, United States· Aktiv men inte rekryterande
- Artemis Institute for Clinical ResearchVerifierat postnummerSan Diego, USA· Aktiv men inte rekryterande
- UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission BayVerifierat postnummerSan Francisco, USA· Aktiv men inte rekryterande
- Accel Research Sites - Lakeland Clinical Research UnitVerifierat postnummerLakeland, USA· Aktiv men inte rekryterande
- Innovative Clinical ResearchVerifierat postnummerLauderhill, United States· Aktiv men inte rekryterande
- K2 Medical Research - MaitlandVerifierat postnummerMaitland, USA· Aktiv men inte rekryterande
- K2 Medical Research ORLANDOVerifierat postnummerMaitland, USA· Aktiv men inte rekryterande
- Life Arc Research Centers - MiamiVerifierat postnummerMiami, USA· Aktiv men inte rekryterande
- Wellness Research CenterVerifierat postnummerMiami, USA· Aktiv men inte rekryterande
Vanliga frågor
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.
Vad är en 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.
Hur länge kommer jag att vara med i studien?
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.
Kan jag sluta delta i studien när som helst?
Yes, you are free to leave the study at any point and for any reason, without it affecting your regular medical care.
Hur du får reda på mer
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.
Intresserad av att delta?
Diskussion
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