- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05520775
Semaglutide for Alcohol Use Disorder
May 6, 2024 updated by: University of North Carolina, Chapel Hill
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC-Chapel Hill
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Sham/Placebo
Participants will receive sham subcutaneous injections over 9 weeks.
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Sham subcutaneous injection
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Experimental: Semaglutide
Participants will receive semaglutide via subcutaneous injections at escalating doses (.25mg to 1.0mg) over 9 weeks.
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Semaglutide (subcutaneous)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Volume of Alcohol Consumed
Time Frame: baseline (Week 0) to post-medication (Week 8)
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Volume of alcohol consumed during a self-administration procedure
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baseline (Week 0) to post-medication (Week 8)
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Change in Breath Alcohol Concentration
Time Frame: baseline (Week 0) to post-medication (Week 8)
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Peak breath alcohol concentration during a self-administration procedure
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baseline (Week 0) to post-medication (Week 8)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Subjective Stimulation from Alcohol (Biphasic Effects of Alcohol questionnaire)
Time Frame: baseline (Week 0) to post-medication (Week 8)
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Seven questions from the Biphasic Effects of Alcohol questionnaire 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".
Scores range from 0 to 70.
Higher scores indicate more stimulation effects.
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baseline (Week 0) to post-medication (Week 8)
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Change in Subjective Sedation from Alcohol (Biphasic Effects of Alcohol questionnaire)
Time Frame: baseline (Week 0) to post-medication (Week 8)
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Seven questions from the Biphasic Effects of Alcohol questionnaire used to collect self-reported sedative feelings during an alcohol challenge procedure.
Possible responses are 0 "not at all" through 10 "extremely".
Scores range from 0 to 70.
Higher scores indicate more sedative effects.
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baseline (Week 0) to post-medication (Week 8)
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Change in Alcohol Demand (Alcohol Purchase Task)
Time Frame: baseline (Week 0) to post-medication (Week 8)
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The Alcohol Purchase Task is a 20-question self-reported measure to understand motivation for obtaining alcohol which asks participants about the number of drinks they would purchase and consume based on an increasing drink cost.
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baseline (Week 0) to post-medication (Week 8)
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Change in Cigarette Demand (Cigarette Purchase Task)
Time Frame: baseline (Week 0) to post-medication (Week 8)
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Self-reported cigarette demand during an alcohol challenge procedure
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baseline (Week 0) to post-medication (Week 8)
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Change in Daily Alcohol Use (Timeline Followback questionnaire)
Time Frame: baseline (Week 0) to study endpoint (Week 10)
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Self-reported drinks per day
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baseline (Week 0) to study endpoint (Week 10)
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Change in Daily Cigarette Use (Timeline Followback questionnaire)
Time Frame: baseline (Week 0) to study endpoint (Week 10)
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Self-reported cigarettes per day
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baseline (Week 0) to study endpoint (Week 10)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in HbA1c
Time Frame: baseline (Week 0) to study endpoint (Week 10)
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Hemoglobin A1C (HbA1c)
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baseline (Week 0) to study endpoint (Week 10)
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Change in Weight
Time Frame: baseline (Week 0) to study endpoint (Week 10)
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Body weight
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baseline (Week 0) to study endpoint (Week 10)
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Change in Alcohol elimination
Time Frame: baseline (Week 0) to post-medication (Week 8)
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Rate of alcohol elimination following an alcohol challenge procedure
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baseline (Week 0) to post-medication (Week 8)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christian Hendershot, Ph.D., UNC-Chapel Hill
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 2, 2022
Primary Completion (Actual)
April 12, 2024
Study Completion (Actual)
April 19, 2024
Study Registration Dates
First Submitted
August 26, 2022
First Submitted That Met QC Criteria
August 26, 2022
First Posted (Actual)
August 30, 2022
Study Record Updates
Last Update Posted (Actual)
May 8, 2024
Last Update Submitted That Met QC Criteria
May 6, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-1689
- R21AA026931-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
IPD will be shared with other investigators upon reasonable request.
IPD Sharing Time Frame
Data will become available following publication of study manuscripts and will be available indefinitely.
IPD Sharing Access Criteria
Reasonable request from qualified investigator.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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