Clinical Trial of Rybelsus (Semaglutide) Among Adults With Alcohol Use Disorder (AUD)
Study Details
Study Description
Brief Summary
This study is a randomized controlled trial of oral semaglutide among treatment-seeking individuals with AUD. The investigators will randomly assign 50 participants to receive semaglutide (titrated to 7 milligrams (mg) per day) or matched placebo for 8 weeks. The primary aims are to assess the safety and tolerability of semaglutide in this population and to evaluate its effects, relative to placebo, on alcohol cue-elicited craving and alcohol consumption.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
A screening visit will be conducted at which written informed consent will be obtained and inclusion/exclusion criteria will be assessed. Subsequently, eligible participants will be randomly assigned to take oral semaglutide or matched placebo for 8 weeks, with the semaglutide dose titrated from 3 milligrams (mg)/day for the first 4 weeks to 7 milligrams (mg)/day for the second 4 weeks. Participants will complete 7 additional clinic visits (weekly during the first 4 weeks of the treatment period and biweekly during the second 4 weeks). At each visit, participants will also engage in a computerized behavioral intervention. At screening and again at the Week 6 visit, participants will complete an alcohol cue reactivity task. At the Week 1 visit, before ingesting the first dose of study medication, and again at the Week 8 visit, participants will complete a functional MRI session.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Participants in this Arm will take a medically inert placebo. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the capsule orally each morning. |
Drug: Placebo
A medically inert placebo medication will be taken for 8 weeks.
|
| Active Comparator: Semaglutide 3 milligrams and 7 milligrams Participants in this Arm will study medication for a total of 8 weeks - on semaglutide 3 milligrams per day for 4 weeks, then 7 milligrams per day for 4 weeks. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the capsule orally each morning. |
Drug: Semaglutide 3 MG [Rybelsus]
Semaglutide 3 mg will be taken for the first 4 weeks of the 8-week trial.
Other Names:
Drug: Semaglutide 7 MG [Rybelsus]
Semaglutide 7 mg will be taken for the second 4 weeks of the 8-week trial.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Cue Craving Visual Analog Score [7 weeks - change between screening and Week 6 visit]
The primary efficacy endpoint will be the magnitude of change between screening and Week 6 in the cue-craving VAS score on the first VAS item ("How strong is your craving to drink alcohol?") administered after the alcohol cue presentation. Scores range from 0 (none) to 20 (extremely strong). Higher scores indicate a higher level of craving.
Secondary Outcome Measures
- Number of drinks per day [4 weeks]
The number of standard alcoholic drinks participants consume per day during the last 4 weeks of the treatment period (Week 5-8), as reported on the Timeline Follow-Back Interview.
- Percentage of heavy drinking days [4 weeks]
The percentage of heavy drinking days during the last 4 weeks of the treatment period (Week 5-8), as reported on the Timeline Follow-Back Interview.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 21 or older.
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Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for current AUD of at least moderate severity, as assessed by the Mini International Neuropsychiatric Interview (MINI).
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Seeking pharmacological treatment for AUD and wants to stop or cut down on drinking.
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Has a body mass index (BMI) of at least 25 kg/m2.
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Able to read and understand questionnaires and informed consent.
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Lives within 50 miles of the study site.
Please contact clinical site for additional inclusion criteria.
Exclusion Criteria:
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Current DSM-5 diagnosis of any other substance use disorder of moderate or greater severity, except for Nicotine Use Disorder, as assessed by MINI.
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Urine drug screen at screening positive for any substance except cannabis.
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Current DSM-5 bipolar disorder, major depressive episode, or panic disorder, as assessed by MINI.
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Current or lifetime eating disorder (anorexia, bulimia, or binge eating disorder) or psychotic disorder, as assessed by MINI.
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Current suicidal ideation or homicidal ideation.
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Current use of other psychotropic medications except antidepressants (for which dose must be stable for at least the past 2 months).
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Current or past-month use of AUD pharmacotherapy, including (e.g., oral naltrexone, acamprosate, or disulfiram) or current or past 60-day use of injectable naltrexone.
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Current psychotherapy in which the primary focus is AUD. Attendance at Alcoholics Anonymous (AA) meetings is not exclusionary.
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Current or past-month use of weight control medications.
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Current or past-month use of metformin for any indication.
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Any prior use of semaglutide or other GLP-1 agonists.
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History of severe alcohol withdrawal (e.g., seizure, delirium tremens), as evidenced by self- report and assessment with Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar).
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Current or lifetime Type 1 or Type 2 diabetes diagnosis, or HbA1c >6.5%.
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Current or lifetime kidney disease or creatinine clearance <80 mL/min for participants <=55 years of age (<65 mL/min for those >55).
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Personal history of gastrointestinal disease (e.g., gastroparesis) or pancreatitis.
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Personal or family history of medullary thyroid carcinoma and/or multiple endocrine neoplasia syndrome type 2
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Current or past hepatocellular disease, as indicated by verbal report or elevations of serum amylase, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of the normal range at screening.
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Uncontrolled hypertension (systolic BP >160 mmHg or diastolic >100 mmHg).
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Biological females of childbearing potential who are pregnant (by plasma HCG), nursing, or who are not using a reliable form of contraception.
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Lack of a stable living situation.
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(If participating in MRI sessions) Contraindications to MRI scanning, ferrous metal in the body including intracranial, intraorbital, or intraspinal metal, pacemakers, cochlear implants, other non-MRI-compatible devices, or other devices that could compromise the quality of the MRI images such as a permanent top retainer or braces.
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(If participating in MRI sessions) Severe claustrophobia or morbid obesity that preclude placement in the MRI scanner.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Colorado Anschutz Medical Campus | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- University of Colorado, Denver
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
- Principal Investigator: Joseph P Schacht, PhD, University of Colorado - Anschutz Medical Campus
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 23-0261
- R21AA031146