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).
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
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
48
Semaglutide (subcutaneous)
Sham subcutaneous injection
UNC-Chapel Hill
Chapel Hill, North Carolina, United States
Change in Alcohol Consumed
Estimated grams of ethanol consumed.
Time frame: Baseline (Week 0) to post-medication (Week 8)
Change in Breath Alcohol Concentration
Peak breath alcohol concentration following an alcohol self-administration procedure.
Time frame: Baseline (Week 0) to post-medication (Week 8)
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.
Time frame: Baseline (Week 0) to post-treatment (Week 8)
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.
Time frame: baseline (Week 0) to post-medication (Week 8)
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.
Time frame: Baseline (Week 0) to post-treatment (Week 8)
Change in Cigarette Demand (Cigarette Purchase Task)
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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.
Time frame: Baseline (Week 0) to Post-medication (Week 8)
Change in Daily Alcohol Use
Self-reported drinks per day averaged across study week.
Time frame: baseline (Week 0) to study endpoint (Week 10)
Change in Daily Cigarette Use
Self-reported cigarettes per day
Time frame: baseline (Week 0) to study endpoint (Week 10)