History of Changes for Study: NCT05520775

Semaglutide for Alcohol Use Disorder

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Study Record Versions

Version	Submitted Date	Changes
1	August 26, 2022	None (earliest Version on record)
2	September 1, 2022	Outcome Measures, Sponsor/Collaborators, Study Status and Study Identification
3	October 11, 2022	Study Status
4	November 14, 2023	Study Status, Study Description, Contacts/Locations and Eligibility
5	March 6, 2024	Recruitment Status, Study Status, Contacts/Locations and Study Design
6	May 6, 2024	Recruitment Status and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	21-1689
Brief Title:	Semaglutide for Alcohol Use Disorder
Official Title:	Human Laboratory Screening of Semaglutide for Alcohol Use Disorder
Secondary IDs:

Study Status


Record Verification:	August 2022
Overall Status:	Recruiting
Study Start:	September 2022
Primary Completion:	August 2023 [Anticipated]
Study Completion:	October 2023 [Anticipated]

First Submitted:	August 26, 2022
First Submitted that Met QC Criteria:	August 26, 2022
First Posted:	August 30, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	August 26, 2022
Last Update Posted:	August 30, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	University of North Carolina, Chapel Hill
Responsible Party:	Principal Investigator Investigator: Christian Hendershot, MS, PhD Official Title: Research Associate Professor Affiliation: University of North Carolina, Chapel Hill
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

Brief Summary:

Pharmacotherapy development remains a critical objective for reducing health and societal burdens associated with alcohol use disorder (AUD). Developing targeted treatments for specific AUD subgroups is a key aim under the NIAAA medication development strategy. Among those with AUD, cigarette smokers comprise a sizable and critical subgroup with disproportionally high long-term health risks, making it a key priority to advance therapies for concurrent AUD and cigarette smoking. Recent preclinical evidence indicates that glucagon-type peptide-1, an incretin hormone, impacts both alcohol and nicotine motivation and intake. This project will utilize human laboratory screening procedures to evaluate a GLP-1 receptor agonist as a novel candidate therapy for smokers with AUD. Participants who meet criteria for AUD and report smoking will complete laboratory alcohol administration procedures while receiving medication or placebo. This study will provide initial human data on the effects of a GLP-1 receptor agonist in relation to alcohol-related outcomes, including both alcohol and nicotine motivation, in participants with AUD. Validation of a candidate monotherapy for joint alcohol and nicotine reduction could have substantial public health impact.

Detailed Description:

Conditions


Conditions:	Alcohol Use Disorder Cigarette Smoking
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Basic Science
Study Phase:	Phase 2
Interventional Study Model:	Parallel Assignment
	Randomized parallel group design.
Number of Arms:	2
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	48 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Semaglutide Participants will receive semaglutide via subcutaneous injections at escalating doses (.25mg to 1.0mg) over 9 weeks.	Drug: Semaglutide Semaglutide (subcutaneous)
Sham Comparator: Sham/Placebo Participants will receive sham subcutaneous injections over 9 weeks.	Drug: Sham/placebo Sham subcutaneous injection

Outcome Measures


Primary Outcome Measures:
1.	Volume of alcohol consumed [ Time Frame: Change in outcome from baseline (Week 0) to post-medication (Week 8) ] Volume of alcohol consumed during a self-administration procedure
2.	Breath alcohol concentration [ Time Frame: Change in outcome from baseline (Week 0) to post-medication (Week 8) ] Peak breath alcohol concentration during a self-administration procedure
Secondary Outcome Measures:
1.	Subjective response to alcohol [ Time Frame: Change in outcome from baseline (Week 0) to post-medication (Week 8) ] Self-reported stimulation and sedation during an alcohol challenge procedure
2.	Drug demand [ Time Frame: Change in outcome from baseline (Week 0) to post-medication (Week 8) ] Self-reported alcohol and cigarette demand during an alcohol challenge procedure
3.	Daily alcohol use [ Time Frame: Change in outcome from baseline (Week 0) to study endpoint (Week 10) ] Self-reported drinks per day
4.	Daily cigarette use [ Time Frame: Change in outcome from baseline (Week 0) to study endpoint (Week 10) ] Self-reported cigarettes per day
Other Outcome Measures:
1.	Weight [ Time Frame: Change in outcome from baseline (Week 0) to study endpoint (Week 10) ] Body weight
2.	HbA1c [ Time Frame: Change in outcome from baseline (Week 0) to study endpoint (Week 10) ] Hemoglobin A1C
3.	Alcohol elimination [ Time Frame: Change in outcome from baseline (Week 0) to post-medication (Week 8) ] Rate of alcohol elimination following an alcohol challenge procedure

Eligibility


Minimum Age:	21 Years
Maximum Age:	65 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
Criteria:	Inclusion Criteria: Age 21-65 Meeting DSM-5 criteria for current (past year) mild or moderate AUD (i.e., from 2-5 symptoms endorsed), and 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) Daily smoker, defined as reporting smoking 1+ cigarettes per day, on average, over the past 12 months (past year avg cigarettes per day ≥ 1) and daily/near-daily smoking in the past month (smoking at least 25 days in the past 30) 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: Regular use of electronic nicotine delivery systems (ENDs; vaping), cigars, chewing tobacco or snuff, based on at least weekly use in the past 30 days Past 30-day use of nicotine replacement therapies/products 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 or smoking cessation 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 TSH >6.0 mIU/L or <0.4 mIU/L 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) <25kg/m2 or >35kg/m2 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)

Contacts/Locations


Central Contact Person:	Christian Hendershot, Ph.D. Telephone: (919) 962-5565 Email: christian_hendershot@med.unc.edu
Central Contact Backup:	Margret Powell Email: margret_powell@med.unc.edu
Study Officials:	Christian Hendershot, Ph.D. Principal Investigator UNC-Chapel Hill
Locations:	United States, North Carolina
	UNC-Chapel Hill [Recruiting] Chapel Hill, North Carolina, United States, 27599 Contact:Contact: Christian Hendershot, Ph.D. 919-962-5565 christian_hendershot@med.unc.edu

IPDSharing


Plan to Share IPD:	Yes IPD will be shared with other investigators upon reasonable request.
	Supporting Information: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
	Time Frame: Data will become available following publication of study manuscripts and will be available indefinitely.
	Access Criteria: Reasonable request from qualified investigator.
	URL:

References


Citations:
Links:
Available IPD/Information: