Randomized, Controlled Trial of Rybelsus (Semaglutide) Among Adults With Alcohol Use Disorder (AUD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Cue Craving Visual Analog Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will be blind to medication assignment, as will all care providers and investigators.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 or older.
- •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).
- •Seeking pharmacological treatment for AUD and wants to stop or cut down on drinking.
- •Has a body mass index (BMI) of at least 25 kg/m
- •Able to read and understand questionnaires and informed consent.
- •Lives within 50 miles of the study site.
- •Please contact clinical site for additional inclusion criteria.
排除标准
- •Current DSM-5 diagnosis of any other substance use disorder of moderate or greater severity, except for Nicotine Use Disorder, as assessed by MINI.
- •Urine drug screen at screening positive for any substance except cannabis.
- •Current DSM-5 bipolar disorder, major depressive episode, or panic disorder, as assessed by MINI.
- •Current or lifetime eating disorder (anorexia, bulimia, or binge eating disorder) or psychotic disorder, as assessed by MINI.
- •Current suicidal ideation or homicidal ideation.
- •Current use of other psychotropic medications except antidepressants (for which dose must be stable for at least the past 2 months).
- •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.
- •Current psychotherapy in which the primary focus is AUD. Attendance at Alcoholics Anonymous (AA) meetings is not exclusionary.
- •Current or past-month use of weight control medications.
- •Current or past-month use of metformin for any indication.
- •Any prior use of semaglutide or other GLP-1 agonists.
- •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).
- •Current or lifetime Type 1 or Type 2 diabetes diagnosis, or HbA1c >6.5%.
- •Current or lifetime kidney disease or creatinine clearance <80 mL/min for participants <=55 years of age (<65 mL/min for those >55).
- •Personal history of gastrointestinal disease (e.g., gastroparesis) or pancreatitis.
- •Personal or family history of medullary thyroid carcinoma and/or multiple endocrine neoplasia syndrome type 2
- •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.
- •Uncontrolled hypertension (systolic BP >160 mmHg or diastolic >100 mmHg).
- •Biological females of childbearing potential who are pregnant (by plasma HCG), nursing, or who are not using a reliable form of contraception.
- •Lack of a stable living situation.
- •(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.
- •(If participating in MRI sessions) Severe claustrophobia or morbid obesity that preclude placement in the MRI scanner.
研究组 & 干预措施
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.
干预措施: Placebo (Drug)
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.
干预措施: Semaglutide 3 MG [Rybelsus] (Drug)
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.
干预措施: Semaglutide 7 MG [Rybelsus] (Drug)
结局指标
主要结局
Change in Cue Craving Visual Analog Score
时间窗: 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.
次要结局
- Number of drinks per day(4 weeks)
- Percentage of heavy drinking days(4 weeks)
- Change in alcohol cue-elicited brain activation(8 weeks)