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Semaglutide for Alcoholism (STAR-T Trial)
Phase 2
Recruiting
Led By William K Simmons, Ph.D.
Research Sponsored by Oklahoma State University Center for Health Sciences
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 baseline (week 1) to post-medication (week 13
Awards & highlights
STAR-T Trial Summary
This trial will test if a drug can reduce drinking in people with signs of alcohol use disorder.
Who is the study for?
This trial is for adults with Alcohol Use Disorder who drink more than a moderate amount weekly and can consent to the study. They must be in stable health, not have certain mental health conditions or hearing loss, and women should use effective birth control. People with diabetes, severe kidney issues, high triglycerides, or those on specific medications cannot join.Check my eligibility
What is being tested?
The study tests if semaglutide can safely reduce alcohol consumption compared to a placebo (a substance with no therapeutic effect). Participants will receive either the actual drug or placebo without knowing which one they are getting.See study design
What are the potential side effects?
Semaglutide may cause side effects like nausea, headache, digestive problems, low blood sugar levels (in people with diabetes), and possible allergic reactions. Not everyone will experience these side effects.
STAR-T Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (week 1) to post-medication (week 13
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 1) to post-medication (week 13
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in alcohol drinking
Secondary outcome measures
Change in blood phosphatidylethanol (PEth) levels as a biomarker of alcohol use
Change in drinks per drinking days
Change in heavy drinking days
+5 moreSide 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
STAR-T Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SemaglutideExperimental Treatment1 Intervention
Participants will receive subcutaneous injections of semaglutide in escalating doses (.25mg to 1.0mg) over the course of 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive subcutaneous injections of a placebo saline solution over the course of 12 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?
Oklahoma State University Center for Health SciencesLead Sponsor
35 Previous Clinical Trials
5,176 Total Patients Enrolled
National Institute of Drug AbuseFED
9 Previous Clinical Trials
14,439 Total Patients Enrolled
William K Simmons, Ph.D.Principal InvestigatorOklahoma State University Center for Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am following the required birth control and pregnancy testing guidelines.I am 18 years old or older.I have a known history of specific medical conditions or surgeries.I am currently taking medication to lower my blood sugar.I haven't taken any weight loss drugs in the last 3 months.I have a known history of ear or balance disorders.My heart condition is stable.My vision and hearing are normal, or corrected to be normal.My BMI is either below 25 or above 50.I am not taking any medications that interact with semaglutide.I have diabetes or my HbA1c level is 6.5% or higher.My physical or mental health is stable.
Research Study Groups:
This trial has the following groups:- Group 1: 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: NCT05891587 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this research still in progress?
"Per clinicaltrials.gov, this investigation is no longer recruiting patients as of June 5th 2023. It was first posted on the 1st of June and has not been updated since its last update a few days later. Fortunately, there are 273 additional studies actively searching for participants at present."
Answered by AI
Has the U.S. Food and Drug Administration given Semaglutide its stamp of approval?
"Semaglutide was determined to be a 2 on the safety scale, as no studies have proven its efficacy yet and there is only some evidence of it being safe."
Answered by AI
Who else is applying?
What state do they live in?
South Carolina
What site did they apply to?
OSU Biomedical Imaging Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
How often will I need to travel to Oklahoma?
PatientReceived no prior treatments
Why did patients apply to this trial?
I am struggling to reduce my drinking without sucess. I have been a functioning alcoholic my adult life but in retirement it is really impacting my health.
PatientReceived no prior treatments
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