Semaglutide Treatment for Alcohol Use Disorder After Metabolic and Bariatric Surgery: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Percent weight change
研究概览
简要总结
The purpose of this research study is to evaluate the feasibility of treating Alcohol Use Disorder with Semaglutide after metabolic and bariatric surgery in adults with overweight or obesity.
详细描述
This study aims to evaluate the feasibility and acceptability of treating Alcohol Use Disorder with Semaglutide after metabolic and bariatric surgery in adults with overweight/obesity. This study will also examine changes in alcohol use disorder and weight. It is hypothesized that the treatment will be feasible and acceptable to participants, and result in reductions in alcohol use and weight.
A recently published randomized controlled trial provided preliminary evidence that Semaglutide can reduce some alcohol craving and drinking outcomes; however, this has not been examined in individuals with a history of bariatric surgery who are at increased risk of alcohol misuse and Alcohol Use Disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Post-treatment and six-month follow-up assessments will be completed by a study clinician that is blind to treatment group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study (up to 6 months: 3-month treatment plus 3-month follow up)
- •Age 18 and older
- •Have a BMI ≥30 (or BMI ≥27 with a medical comorbidity) and BMI ≤50 kg/m2
- •Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy within the past seven years
- •Meet current DSM-5 criteria for Alcohol Use Disorder
- •Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators
- •Read, comprehend, and write English at a sufficient level to complete study-related materials
- •For females of reproductive potential: use of highly effective contraception and agreement to use such a method during study participation
排除标准
- •Any of the following: myocardial infarction, stroke, hospitalization for unstable angina, or transient ischemic attack within the past 60 days prior to screening
- •History or presence of chronic or recurrent pancreatitis
- •History of malignant neoplasms within the past 5 years prior to screening
- •Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2
- •Is currently using other medications for weight loss or other GLP-1 receptor agonists
- •Has a history of allergy or sensitivity to Semaglutide
- •Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression)
- •Has untreated hypertension with a seated systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg, or heart rate > 100 beats/minute
- •Has current uncontrolled hypertension
- •Has current uncontrolled Type I or Type II diabetes mellitus
- •Has untreated hypothyroidism with a TSH > 1.5 times the upper limit of normal for the test laboratory with repeat value that also exceeds this limit
- •Has active gallbladder disease
- •Has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder
- •Has a recent history of substance use disorder (with the exception of cannabis or tobacco use disorder) within the past 12 months
- •Is currently engaging in other treatment for Alcohol Use Disorder or making intentional efforts to quit alcohol use
- •Is currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device
- •Is breast-feeding, pregnant, or not using a reliable form of birth control
- •Reports active suicidal or homicidal ideation
- •Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria which, in the investigator's opinion, might have jeopardized the participant's safety or compliance with the protocol
研究组 & 干预措施
Semaglutide
Participants randomized to Semaglutide will be initiated on a 0.25 mg dose (injection) once weekly for 4 weeks (first month) with an escalation to 0.5 mg for the second month, and 1.0 mg in the final month. Participants will be on Semaglutide for three months total.
干预措施: Semaglutide 1.0 mg (Drug)
Wait-list control
Participants randomized to wait-list control will be followed for three months but no treatment will be administered. At the conclusion of the study, participants in the wait list control group will be offered a three-month behavioral intervention to treat Alcohol Use Disorder, although this is not required.
结局指标
主要结局
Percent weight change
时间窗: Baseline, Week 12, 6-month follow-up
Percent weight change will be calculated. Negative values are indicative of weight loss. Positive values are indicative of weight gain.
Mean drinks per calendar day to assess alcohol use
时间窗: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean drinks per calendar day will be assessed through timeline follow back interviews
Mean drinks per drinking day to assess Alcohol use
时间窗: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean drinks per drinking day will be assessed through timeline follow back interviews
Mean number of heavy drinking days to assess Alcohol use
时间窗: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean number of heavy drinking days will be assessed through timeline follow back interviews
Mean number of drinking vs abstinent days to assess Alcohol use
时间窗: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean number of drinking vs abstinent days will be assessed through timeline follow back interviews
次要结局
未报告次要终点