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GLP-1 Receptor Agonist
Semaglutide for Alcoholism
Phase 2
Recruiting
Led By Joseph P Schacht, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 weeks - change between screening and week 6 visit
Awards & highlights
Study Summary
This trial will assess the safety and effectiveness of a drug to reduce alcohol cravings and consumption in people with alcohol use disorder.
Who is the study for?
Adults over 21 with Alcohol Use Disorder seeking treatment, having a BMI of at least 25 kg/m2, and living within 50 miles of the study site. Excluded are those with certain mental health conditions, using specific medications or therapies for AUD or weight control, past use of GLP-1 agonists like semaglutide, severe alcohol withdrawal history, diabetes, kidney disease, gastrointestinal diseases including pancreatitis, uncontrolled hypertension or liver issues.Check my eligibility
What is being tested?
The trial tests oral semaglutide (up to 7 mg daily) against a placebo in individuals with AUD for its safety and effects on craving and consumption of alcohol. This is an 8-week randomized controlled trial where participants are chosen by chance to receive either the drug or placebo.See study design
What are the potential side effects?
Semaglutide may cause digestive issues such as nausea and constipation; rare but serious side effects include inflammation of the pancreas (pancreatitis), changes in vision due to retinal damage (diabetic retinopathy), kidney problems including kidney failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 weeks - change between screening and week 6 visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 weeks - change between screening and week 6 visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Cue Craving Visual Analog Score
Secondary outcome measures
Number of drinks per day
Percentage of heavy drinking days
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Semaglutide 3 milligrams and 7 milligramsActive Control2 Interventions
Participants in this Arm will study medication for a total of 8 weeks - on semaglutide 3 milligrams per day for 4 weeks, then 7 milligrams per day for 4 weeks. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the capsule orally each morning.
Group II: PlaceboPlacebo Group1 Intervention
Participants in this Arm will take a medically inert placebo. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the capsule orally each morning.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,391 Total Patients Enrolled
12 Trials studying Alcoholism
1,581 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
802 Previous Clinical Trials
1,365,310 Total Patients Enrolled
424 Trials studying Alcoholism
985,733 Patients Enrolled for Alcoholism
Joseph P Schacht, PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus
3 Previous Clinical Trials
312 Total Patients Enrolled
3 Trials studying Alcoholism
312 Patients Enrolled for Alcoholism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been taking metformin in the past month.I have been diagnosed with bipolar disorder, depression, or panic disorder.I am not pregnant, nursing, or I am using reliable birth control.I am 21 years old or older.I have used weight control medications in the last month.I want to reduce or stop my alcohol consumption with medication.I have diabetes or my HbA1c level is above 6.5%.I am only taking antidepressants, and the dose has been stable for 2 months.I have used alcohol use disorder medication in the last month or 60 days.I am currently in psychotherapy for alcohol use disorder, but I also attend AA meetings.My kidney function is reduced based on my age.I have had stomach issues or pancreatitis before.I have used semaglutide or other GLP-1 agonists before.I have or had liver disease, shown by high liver enzyme levels.I or my family have a history of thyroid cancer or MEN2.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Semaglutide 3 milligrams and 7 milligrams
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How detrimental are the impacts of Semaglutide 3mg and 7mg?
"Our experts at Power rated Semaglutide's safety a 2, as this is an experimental Phase 2 trial and there exists evidence of potential security but no data to support its efficacy."
Answered by AI
Is this trial currently recruiting participants?
"According to clinicaltrials.gov, this specific study is no longer recruiting patients - the initial posting occurred on July 15th 2023 and was last updated on May 26th 2023. However, there are currently 377 other trials actively sourcing volunteers."
Answered by AI
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