Alcohol Recovery Research Study
Researchers at Maryland Treatment Centers, with sites in Rockville and Baltimore, Maryland, are conducting a study in adults to better understand alcohol dependency and test a new investigational treatment called brenipatide.
Fast Facts
Alcohol users with alcohol-related problems
No major mental health concerns
Compensation
Provided
Remote & In-Person Clinic Visits in Baltimore or Rockville, MD
Study Background
Researchers at Maryland Treatment Centers/Mountain Manor Treatment Center are conducting a study in adults aged 18–75 to understand moderate-to-severe alcohol use disorder, its effects, and whether a new treatment, brenipatide, can help reduce drinking.
Alcohol use disorder (AUD) is a serious condition that affects millions of adults and is associated with physical, mental, and social problems, including impaired health, disrupted relationships, and reduced quality of life. Heavy alcohol use is linked to changes in the brain’s reward and craving pathways, which can make it difficult for individuals to reduce drinking or maintain abstinence.
Current treatment options for moderate-to-severe AUD are limited, and many individuals do not respond adequately to existing therapies. Brenipatide (LY3537031) is an investigational medicine being studied for its potential to target the brain pathways involved in cravings and reward. By evaluating whether brenipatide can reduce heavy drinking, support abstinence, and improve overall well-being, this study aims to expand the understanding of effective treatments for adults struggling with AUD.
The findings from this research may provide valuable insights into new therapeutic approaches, ultimately helping individuals regain control over their drinking and improve their health, social functioning, and quality of life.
Study Background
Researchers at Maryland Treatment Centers/Mountain Manor Treatment Center are conducting a study in adults aged 18–75 to understand moderate-to-severe alcohol use disorder, its effects, and whether a new treatment, brenipatide, can help reduce drinking.
Alcohol use disorder (AUD) is a serious condition that affects millions of adults and is associated with physical, mental, and social problems, including impaired health, disrupted relationships, and reduced quality of life. Heavy alcohol use is linked to changes in the brain’s reward and craving pathways, which can make it difficult for individuals to reduce drinking or maintain abstinence.
Current treatment options for moderate-to-severe AUD are limited, and many individuals do not respond adequately to existing therapies. Brenipatide (LY3537031) is an investigational medicine being studied for its potential to target the brain pathways involved in cravings and reward. By evaluating whether brenipatide can reduce heavy drinking, support abstinence, and improve overall well-being, this study aims to expand the understanding of effective treatments for adults struggling with AUD.
The findings from this research may provide valuable insights into new therapeutic approaches, ultimately helping individuals regain control over their drinking and improve their health, social functioning, and quality of life.
Additional Information
In this research study, we are trying to understand how moderate-to-severe alcohol use disorder affects adults. We aim to better understand the brain pathways involved in cravings, reward, and drinking behavior. Heavy alcohol use can disrupt these pathways, leading to physical, mental, and social problems, and we will measure these effects throughout the study.
We also want to see whether a new treatment, brenipatide, can help reduce heavy drinking, manage cravings, and improve overall health and well-being. To do this, participants will complete a combination of in-person clinic visits, remote check-ins, and daily diaries to track alcohol use and treatment effects. By understanding how brenipatide works, we hope to identify new ways to support adults living with alcohol use disorder and ultimately improve their quality of life.
Inclusion Criteria
- Adults 18–75 years old
- Experience alcohol related problems
- Willing to attend study visits, complete questionnaires, and record alcohol use in a daily diary
- Otherwise generally healthy adult
- Willing to attend study visits, complete questionnaires, and record alcohol use in a daily diary
Exclusion Criteria
- Serious mental health disorders
- Advanced liver disease
- HIV Positive
- Active hepatitis B or C infection
- Current or prior use of GLP-1 or similar incretin therapies
- Currently in an alcohol treatment program that include therapy focused on alcohol use
- History of symptomatic gallbladder disease
- Uncontrolled diabetes or other serious uncontrolled medical conditions
- Severe kidney, heart, or other chronic conditions that may make participation unsafe
The study lasts up to 68 weeks, with follow-up visits afterward. If you join, you will take part in a combination of in-person clinic visits and remote check-ins:
In-person clinic visits:
You will attend regular visits to check your health, provide blood samples, and complete questionnaires about alcohol use and cravings.
You will receive the study medication (brenipatide) or a placebo once a week, which you can self-inject or have a support person administer.
Some visits may include extra assessments depending on your participation (e.g., retinopathy or MRI-PDFF visits).
Remote visits and daily tracking:
Some check-ins will be remote by phone or video for updates or diary reviews.
You will complete daily electronic diaries to log the number of drinks you consume and track your injections.
If you have type 2 diabetes, you may also keep a hypoglycemia diary.
Post-treatment safety:
After your last dose, there will be two follow-up safety visits about 4 and 8 weeks later to ensure your continued well-being.
Compensation: Participants may receive up to $4,000 for completing the study. Payments are provided for each visit. Exact payments for each visit will be reviewed during screening.
There is no cost for you to participate in our research study. Assistance with transportation and meals may be provided during longer study visits.