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GLP-1 Receptor Agonist
Semaglutide for Alcoholism
Phase 2
Waitlist Available
Led By Christian Hendershot, Ph.D.
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 21-65
Willingness/availability to take study medication and complete study procedures, including attending weekly visits for medication administration, side effect assessments, and glucose monitoring
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0) to study endpoint (week 10)
Awards & highlights
Study Summary
This trial will test a new medication for smokers with AUD to see if it impacts both alcohol and nicotine motivation and intake.
Who is the study for?
Adults aged 21-65 who smoke daily, meet criteria for mild or moderate alcohol use disorder (AUD), and drink at risky levels can join this trial. They must be willing to take medication, attend weekly visits, and participate in lab sessions with alcohol administration. Exclusions include regular use of other tobacco products, prior GLP-1 agonist use like semaglutide, current cessation treatments for smoking or drinking, certain medical conditions including uncontrolled hypertension or thyroid disease, history of severe mental illness or cancer within the last five years.Check my eligibility
What is being tested?
The trial is testing semaglutide's effects on adults with AUD by comparing it against a placebo. Semaglutide is a drug that affects glucose control and appetite regulation. Participants will receive either the actual drug or a sham treatment randomly and their responses to alcohol consumption will be monitored.See study design
What are the potential side effects?
Semaglutide may cause side effects such as nausea, vomiting, diarrhea, constipation, abdominal pain; low blood sugar; increased heart rate; pancreatitis; gallbladder problems; kidney problems; allergic reactions including swelling under the skin (urticaria); fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 65 years old.
Select...
I am willing and able to follow the study's medication and visit schedule.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (week 0) to study endpoint (week 10)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0) to study endpoint (week 10)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Respiration
Change in Volume of Alcohol Consumed
Secondary outcome measures
Change in Alcohol Demand (Alcohol Purchase Task)
Change in Cigarette Demand (Cigarette Purchase Task)
Alcohol Use Disorder
+3 moreOther outcome measures
Change in Alcohol elimination
Change in HbA1c
Change in Weight
Side effects data
From 2020 Phase 4 trial • 104 Patients • NCT0418984821%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SemaglutideExperimental Treatment1 Intervention
Participants will receive semaglutide via subcutaneous injections at escalating doses (.25mg to 1.0mg) over 9 weeks.
Group II: Sham/PlaceboPlacebo Group1 Intervention
Participants will receive sham subcutaneous injections over 9 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5160
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,504 Previous Clinical Trials
4,187,614 Total Patients Enrolled
15 Trials studying Alcoholism
2,484 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
799 Previous Clinical Trials
1,362,463 Total Patients Enrolled
422 Trials studying Alcoholism
985,160 Patients Enrolled for Alcoholism
Christian Hendershot, Ph.D.Principal InvestigatorUNC-Chapel Hill
2 Previous Clinical Trials
8 Total Patients Enrolled
1 Trials studying Alcoholism
5 Patients Enrolled for Alcoholism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe liver, kidney, heart, or other major health issues.I am not pregnant, nursing, planning to become pregnant soon, and I use effective birth control.I haven't had cancer, except for some skin cancers or early-stage cancers, in the last 5 years.I or my family have a history of specific thyroid cancer or genetic conditions.I am between 21 and 65 years old.I am willing and able to follow the study's medication and visit schedule.I have had major stomach surgery that could affect medication absorption.I have used vaping, cigars, chewing tobacco, or snuff at least once a week in the last month.You are currently trying to stop drinking alcohol or smoking, or you are actively involved in programs or treatments to help you quit.I have diabetes or my HbA1c level was over 6.5% at screening.I have a history of serious eye conditions related to diabetes.I have used semaglutide or similar medications before.I have not taken Sincalide, Sulfonylureas, insulin, semaglutide, or weight control medications in the last 30 days.You have had a bad allergic reaction to the study medication or similar products before.You have used nicotine replacement therapies or products in the last 30 days.I have not attempted suicide, had thoughts of suicide in the last 30 days, or been hospitalized for psychiatric reasons in the last 6 months.I have had diabetic ketoacidosis in the past.You smoke one or more cigarettes per day on average over the past year, and you have smoked almost every day in the past month.
Research Study Groups:
This trial has the following groups:- Group 1: Sham/Placebo
- Group 2: Semaglutide
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.
Alcoholism Patient Testimony for trial: Trial Name: NCT05520775 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what end is this clinical experiment striving?
"The primary purpose of this medical investigation is to observe changes in Breath Alcohol Concentration (BAC) over the trial period. Additionally, secondary goals are to evaluate alterations in daily alcohol and cigarette use as well as subjective responses to an administered dose of alcohol."
Answered by AI
Can I become an active participant in this research endeavor?
"Eligible applicants must have an alcohol use disorder and be between 21-65 years of age. The research team is looking to recruit a total of 48 participants."
Answered by AI
How many individuals is this clinical trial taking in at this time?
"Affirmative, the info hosted on clinicaltrials.gov affirms that this research project is actively recruiting individuals for participation. It was first posted on September 2nd 2022 and most recently revised October 11th 2022. As of now, 48 participants are needed from a single site."
Answered by AI
Does this research protocol include adults aged 18 or over among its participants?
"This experiment is searching for individuals who are between 21 and 65 years old."
Answered by AI
Does this research program have room for additional participants at present?
"Indeed, clinicaltrials.gov has stated that this research is actively searching for participants. The posting of the trial was on September 2nd 2022 and updates were made most recently on October 11th 2022. This study needs 48 patients to be recruited from one location only."
Answered by AI
Has the regulatory agency given its stamp of approval to Semaglutide?
"Semaglutide receives a score of 2 in regards to safety, given that the trials thus far have only offered preliminary evidence for its security and none regarding efficacy."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
Virginia
North Carolina
Other
What site did they apply to?
UNC-Chapel Hill
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I've read quite a few articles about Ozempic curbs alcohol and nicotine addiction. My husband also took it for four months last year and completely stopped drinking because alcohol suddenly became unappealing to him. And he generally loves alcohol. I've struggled with alcohol addiction since I was sixteen.
PatientReceived 2+ prior treatments
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