Semaglutide Therapy for Alcohol Reduction (STAR)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-110
SponsorNational Institute on Drug Abuse (NIDA)
About this trial
Background:
Alcohol use disorder (AUD) is a problematic pattern of alcohol use accompanied by clinically significant medical consequences. Medications can help most people reduce their drinking, but the number is limited, and additional treatment options are needed.
Objective:
To test if a medication named Semaglutide may reduce alcohol drinking in people with AUD.
Who can participate?
All Adults aged 18 or older with AUD might be eligible to participate in the study.
What will happen during the study?
Participants will visit the National Institute on Drug Abuse (NIDA) in Baltimore once a week for about 20 weeks (5 months). Each visit will last between 2 and 6 hours depending on the tasks scheduled for that visit.
Participants will be assigned by chance (like flipping a coin) to receive either Semaglutide or placebo. A placebo looks just like a real drug but contains no medicine.
The study medication is given as a shot under the skin each week.
Participants will undergo different tests throughout the study:
They will give blood, urine, and saliva samples.
They will engage in self-paced behavioral therapy on a computer.
They will answer questions about their mood, diet, alcohol drinking and craving, tobacco use, etc.
They will taste several sweet liquids and tell their preferences.
They will sit in a bar-like room and be exposed to cues that might make them feel the urge to eat food or drink alcohol.
They will wear a virtual reality headset that creates a cafeteria setting. They will walk the virtual cafeteria and choose food and drinks from a buffet.
They will have a functional magnetic resonance imaging (fMRI) scan to take pictures of their brain. During the scans, participants will be shown pictures of alcohol-containing drinks, food, and other items.They will perform tasks on a computer screen.
Participants will have a follow-up visit about 7 weeks after their last shot.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years old
Alcohol Use Disorder (minimum 2 symptoms on a validated diagnostic tool, e.g., the Mini-International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID))
Self-reported drinking, according to alcohol Timeline Follow-Back (TLFB), of > 7 drinks per week for females or > 14 drinks per week for males during the 28-day period prior to screening plus at least four days with > 3 drinks for females or > 4 drinks for males during the 28-day period prior to screening
Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score < 10
Disqualifiers
BMI < 23 kg/m² or BMI >= 50 kg/m²
Evidence of malnutrition as determined by the Nutrition Risk Screening 2002 (NRS-2002)
Most recent blood tests: creatinine >= 2 mg/dL, eGFR <45 mL/min/1.73 m², triglycerides > 500 mg/dl, ALP > 4x the upper limit of normal, clinically abnormal lipase levels per study clinician
Present diagnosis of diabetes mellitus or blood hemoglobin A1c (HbA1c) >= 6.5 %
Trial design
Design model
Parallel
Treatments tested in this trial
Take Control
BehavioralA computer-delivered behavioral therapy derived from the NIAAA s self-help approach, Rethinking Drinking, developed for use in pharmacotherapy trials.
Semaglutide
DrugWeekly subcutaneous (s.c.) injections of semaglutide (or placebo) up to 2.4 mg/week or maximum tolerated dose (MTD).
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: SemaglutideExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Determine whether semaglutide, compared to placebo, reduces alcohol drinking.
Recording the difference of alcohol consumption between baseline and end of the study is crucial to understand whether drinking amount/patterns change throughout the study, potentially due to the use of semaglutide.
Time frame
Difference in number of standard alcohol-containing drinks consumed / week (Drinks Per Week, DPW) from baseline to end of the study.Secondary outcomes
1
Determine whether semaglutide reduces brain activity in resting-state and/or task-based fMRI scans.
Differences in fMRI outcomes will demonstrate whether the drug changes brain activity at rest and/or in response to tasks.
Time frame
Difference in relevant fMRI measures between the two groups.2
Determine whether semaglutide reduces and/or changes food choices in a virtual reality buffet-like laboratory.
Differences in food choices selected will demonstrate whether the drug changes food-seeking behaviors in a population with AUD.
Time frame
Difference in food selection in the virtual buffet between the two groups.3
Determine whether semaglutide reduces alcohol/food cue-elicited craving assessed in a bar-like laboratory.
Differences in craving scores will demonstrate whether the drug changes cue-reactivity in a population with AUD.
Time frame
Difference in alcohol/food craving scores post exposure between the two groups.4
Determine whether semaglutide reduces blood Phosphatidylethanol (PEth) levels as a biomarker of alcohol use.
Recording the difference of blood PEth levels between baseline and end of the study will provide an objective biomarker of change in alcohol use throughout the study, potentially due to the use of semaglutide.
Time frame
Difference in blood PEth levels from baseline to end of the study.Sponsors and contacts
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Source ClinicalTrials.gov