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Semaglutide for Alcoholism

Phase 2
Recruiting
Led By Lorenzo Leggio, M.D.
Research Sponsored by National Institute on Drug Abuse (NIDA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years old
Self-reported drinking of > 7 drinks per week for females or > 14 drinks per week for males during the 28-day period prior to screening + at least four days with > 3 drinks for females or > 4 drinks for males during the 28-day period prior to screening
Must not have
Present diagnosis of diabetes mellitus or blood hemoglobin A1c (HbA1c) >= 6.5 %
Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up difference in other alcohol-related outcomes (e.g., heavy drinking days, drinks per drinking days, who drinking levels) from baseline to end of the study.
Awards & highlights

Summary

This trial is testing if a medication (Semaglutide) can reduce drinking in adults with Alcohol Use Disorder (AUD). Participants will visit NIDA in Baltimore for ~5 months, take tests, and receive weekly shots.

Who is the study for?
Adults aged 18 or older with Alcohol Use Disorder (AUD) who drink more than a moderate amount weekly and can understand English may join. They shouldn't be on other AUD treatments, have unstable heart conditions, extreme body weight, certain blood test abnormalities, diabetes, or be pregnant. Those with specific medical histories like thyroid cancer or severe allergies to similar drugs are excluded.Check my eligibility
What is being tested?
The STAR trial is testing if Semaglutide can safely help reduce alcohol consumption in people with AUD. Participants will randomly receive either Semaglutide or a placebo as weekly shots for about 5 months at NIDA in Baltimore and undergo tests including blood work, therapy sessions, questionnaires, taste tests, virtual reality experiences and brain scans.See study design
What are the potential side effects?
While the trial description doesn't list side effects specifically for Semaglutide within this context of treating AUD; generally it could include digestive issues like nausea or diarrhea, potential allergic reactions and possibly changes in appetite.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I drink more than the recommended weekly limit for my gender.
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My vision and hearing are normal, or corrected to be normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have diabetes or my HbA1c level is 6.5% or higher.
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I or my family have a history of MTC or MEN 2.
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I have a history of balance disorders or severe motion sickness.
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My heart condition is stable.
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I am pregnant, breastfeeding, planning to become pregnant, or not using effective birth control.
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I have a history of alcohol-related health issues or have had gastric bypass surgery.
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My BMI is either below 25 or above 50.
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I have not attempted suicide nor had suicidal thoughts in the last 2 years.
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My health conditions are stable, both physically and mentally.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~difference in alcohol/food craving scores post exposure between the two groups.
This trial's timeline: 3 weeks for screening, Varies for treatment, and difference in alcohol/food craving scores post exposure between the two groups. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the safety and tolerability of semaglutide in individuals with AUD.
Determine whether semaglutide, compared to placebo, reduces alcohol drinking.
Secondary outcome measures
Determine whether semaglutide reduces alcohol/food cue-elicited craving assessed in a bar-like laboratory.
Determine whether semaglutide reduces and/or changes food choices in a virtual reality buffet-like laboratory.
Determine whether semaglutide reduces blood Phosphatidylethanol (PEth) levels as a biomarker of alcohol use.
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SemaglutideExperimental Treatment2 Interventions
Weekly subcutaneous (s.c.) injections of semaglutide up to 2.4 mg/week or maximum tolerated dose (MTD). Consistent with current recommendations, the dose will be titrated at minimum every four weeks to maximize tolerability and minimize adverse events.
Group II: PlaceboPlacebo Group1 Intervention
Weekly subcutaneous (s.c.) injections of placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160
Take Control
2017
Completed Phase 3
~90

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Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)Lead Sponsor
2,503 Previous Clinical Trials
2,625,531 Total Patients Enrolled
49 Trials studying Alcoholism
28,611 Patients Enrolled for Alcoholism
Lorenzo Leggio, M.D.Principal InvestigatorNational Institute on Drug Abuse (NIDA)
10 Previous Clinical Trials
9,372 Total Patients Enrolled
8 Trials studying Alcoholism
221 Patients Enrolled for Alcoholism
~35 spots leftby Dec 2030