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Alcohol Use DisorderPhase 2NCT05520775

Semaglutide for Alcohol Use Disorder

A Phase 2 study testing Semaglutide in people with Alcohol Use Disorder and Cigarette Smoking, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an early-Phase II human laboratory trial using a randomized, placebo-controlled, dose-ranging design to investigate the effects of semaglutide, a GLP-1 receptor agonist, on alcohol-related outcomes in adults with alcohol use disorder (AUD). Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Alcohol Use Disorder, Cigarette Smoking
What is being tested?
Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteUnited States
Study dates
2 Sep 2022to 19 Apr 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 21-65
  • Meeting DSM-5 criteria for current (past year) alcohol use disorder (with 2-7 symptoms endorsed) and National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria for current at-risk drinking (i.e., >7/14 drinks in one week for women/men, with at least two episodes of 4+/5+ drinks in the past 30 days)
  • Willingness/availability to take study medication and complete study procedures, including attending weekly visits for medication administration, side effect assessments, and glucose monitoring
  • Willingness to complete laboratory sessions involving alcohol administration
  • Ability to communicate and read in English

Who cannot join

  • Reporting past 30-day use of illicit drugs other than cannabis at baseline, or having a positive toxicology screen for illicit drugs other than cannabis at baseline
  • Meeting past-year criteria for a substance use disorder (with the exception of alcohol, tobacco or mild cannabis use disorder)
  • Current engagement in alcohol treatments, or currently engaged in intentional efforts to quit alcohol use
  • Past 30-day use of: Sincalide, Sulfonylureas, insulin and insulin products or other medications that may interact with semaglutide;, or weight control medications
  • Prior use of semaglutide or other GLP-1 agonists
  • Known or suspected hypersensitivity to study medication or related products
Show all 29Show fewer
  • Lifetime diagnosis of severe mental illness (including schizophrenia and bipolar disorder)
  • History of suicide attempt, or recent (past 30 day) suicidal ideation, or psychiatric hospitalization in the last 6 months
  • Current significant medical or neurological illness (based on self-report or medical record) including severe hepatic impairment or cirrhosis, impaired renal function (eGFR <50ml/min), acute or chronic pancreatitis, gastroparesis, gallbladder disease or cholelithiasis, other severe gastrointestinal disease, heart failure, coronary artery disease, stroke, seizure disorder, or other medical condition that poses a risk for the medication or alcohol administration components of the study (as determined by the MD)
  • A personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2A or 2B
  • Calcitonin greater than or equal to 50 ng/L
  • Uncontrolled thyroid disease at screening
  • History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
  • History of Type 1 or Type 2 diabetes, or HbA1c >6.5% measured at screening
  • History of diabetic retinopathy, proliferative retinopathy, or maculopathy
  • History of diabetic ketoacidosis
  • History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)
  • Currently nursing, pregnant, anticipating pregnancy in the next 6 months, or not using a highly effective contraceptive method as judged by the MD, and defined as:
  • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
  • progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
  • intrauterine device
  • intrauterine hormone-releasing system
  • bilateral tubal occlusion
  • vasectomized partner
  • sexual abstinence
  • Elevation of serum lipase, amylase, direct (conjugated) bilirubin, or alkaline phosphatase (ALP), ALT, or AST) more than 3X the upper limit of normal on baseline bloodwork
  • Baseline body mass index (BMI) <23kg/m^2
  • Uncontrolled hypertension or systolic BP >180 mmHg and/or diastolic BP >105 mmHg, averaged from three measurements
  • Plans for travel outside of the local area in the upcoming 12 weeks that would interfere with lab visits during the study period (or other logistic factors that would make it difficult to commit to entire duration of study)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UNC-Chapel Hill

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: Human Laboratory Screening of Semaglutide for Alcohol Use Disorder

This is an early-Phase II human laboratory trial using a randomized, placebo-controlled, dose-ranging design to investigate the effects of semaglutide, a GLP-1 receptor agonist, on alcohol-related outcomes in adults with alcohol use disorder (AUD).

Read the detailed description

This is an early-Phase II human laboratory trial using a randomized, placebo-controlled, dose-ranging design to investigate the effects of semaglutide, a GLP-1 receptor agonist, on laboratory alcohol responses and consumption, naturalistic alcohol consumption, and weight loss in participants with alcohol use disorder (AUD). Participants will attend weekly visits while semaglutide dosage is increased to 1.0mg over a period of approximately 9-10 weeks. Participants will attend weekly visits for medication or placebo administration. At scheduled intervals, participants will complete 4 laboratory sessions involving alcohol self-administration and alcohol challenge to characterize medication effects on alcohol-related outcomes.

Being tested
Semaglutide, Sham/placebo
Medical subject headings
Alcoholism, Cigarette Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    Semaglutide (subcutaneous)

  • Sham/placeboDrug

    Sham subcutaneous injection

Study groups in NCT05520775
Study groupRoleWhat they receive
SemaglutideExperimentalParticipants will receive semaglutide via subcutaneous injections at escalating doses (.25mg to 1.0mg) over 9 weeks.
Receives: Drug: Semaglutide
Sham/PlaceboSham comparatorParticipants will receive sham subcutaneous injections over 9 weeks.
Receives: Drug: Sham/placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Alcohol Consumed

    Estimated grams of ethanol consumed.

    Measured: Baseline (Week 0) to post-medication (Week 8)

  2. Change in Breath Alcohol Concentration

    Peak breath alcohol concentration following an alcohol self-administration procedure.

    Measured: Baseline (Week 0) to post-medication (Week 8)

Secondary outcomes (6)

  1. Change in Subjective Stimulation (Biphasic Alcohol Effects Scale)

    Seven questions from the Biphasic Alcohol Effects Scale used to collect self-reported feelings of stimulation during an alcohol challenge procedure. Possible responses are 0-10, 0 being "not at all" and 10 being "extremely". Scale score ranges from 0 to 70. Higher scores indicate greater stimulation effects.

    Measured: Baseline (Week 0) to post-treatment (Week 8)

  2. Change in Subjective Sedation (Biphasic Alcohol Effects Scale)

    Seven questions from the Biphasic Alcohol Effects Scale used to collect self-reported sedative effects during an alcohol challenge procedure. Possible responses are 0 "not at all" through 10 "extremely". Scale scores range from 0 to 70. Higher scores indicate greater sedative effects.

    Measured: baseline (Week 0) to post-medication (Week 8)

  3. Change in Alcohol Demand (Alcohol Purchase Task)

    The Alcohol Purchase Task is a 20-question self-report measure which asks participants about the number of drinks they would purchase and consume based at different monetary costs. Intensity scores reflect the number of drinks that would be purchased when cost is zero.

    Measured: Baseline (Week 0) to post-treatment (Week 8)

  4. Change in Cigarette Demand (Cigarette Purchase Task)

    Self-report cigarette demand as measured by the Cigarette Purchase Task. Intensity scores reflect the number of cigarettes that would be purchased when cost is zero.

    Measured: Baseline (Week 0) to Post-medication (Week 8)

  5. Change in Daily Alcohol Use

    Self-reported drinks per day averaged across study week.

    Measured: baseline (Week 0) to study endpoint (Week 10)

  6. Change in Daily Cigarette Use

    Self-reported cigarettes per day

    Measured: baseline (Week 0) to study endpoint (Week 10)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2022
  2. Study start2 Sep 2022
  3. Primary completion12 Apr 2024
  4. Study completion19 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized parallel group design.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05520775
Sponsor's protocol ID
21-1689
Other IDs
R21AA026931-02
Status last verified
May 2024
First submitted
26 Aug 2022
Last updated
2 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD will be shared with other investigators upon reasonable request.

Publications

  • Hendershot CS, Bremmer MP, Paladino MB, Kostantinis G, Gilmore TA, Sullivan NR, Tow AC, Dermody SS, Prince MA, Jordan R, McKee SA, Fletcher PJ, Claus ED, Klein KR. Once-Weekly Semaglutide in Adults With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Apr 1;82(4):395-405. doi: 10.1001/jamapsychiatry.2024.4789.

    PubMed 39937469

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Semaglutide in people with Alcohol Use Disorder and Cigarette Smoking, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Alcohol Consumed (time frame: Baseline (Week 0) to post-medication (Week 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05520775, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.

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Semaglutide for Alcohol Use Disorder (NCT05520775) | AzTrials