NCT04662801已完成2 期
A Behavioral Treatment With Sequenced Adjunctive Pharmacotherapy for Weight Regain After Bariatric Surgery: A Pilot Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Body Mass Index
研究概览
简要总结
This study will examine behavioral and pharmacologic (Naltrexone+Bupropion) treatments for weight regain after bariatric surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be in the age range ≥18 years of age and ≤70 years of age
- •Have a BMI ≥30 (or BMI ≥27 with a medical comorbidity) and ≤50 kg/m2
- •Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
- •Experiencing weight regain after bariatric surgery
- •Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies).
- •Read, comprehend, and write English at a sufficient level to complete study-related materials.
- •Provide a signed and dated written informed consent prior to study participation.
- •Be available for participation in the study for up to 3 months.
排除标准
- •Has a predisposition to seizures (e.g., subject with a history or evidence of seizure disorder, febrile seizures during childhood, brain tumor, cerebrovascular disease, or significant head trauma; has a family history of idiopathic seizure disorder or is currently being treated with medications or treatment regimens that lower seizure threshold).
- •Has a history of anorexia nervosa or history of bulimia nervosa.
- •Is currently taking a medication that is a contraindication to NB medication (e.g., MAOI, opiates).
- •Is currently using other medications for weight loss.
- •Has a history of allergy or sensitivity to bupropion or naltrexone.
- •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 a history of congenital heart disease, cardiovascular disease, cardiac arrhythmias requiring medication, or a history of cerebrovascular pathology including stroke.
- •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 gallbladder disease.
- •Has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder.
- •Has a recent history of drug or alcohol dependence (since having bariatric surgery).
- •Is currently in active treatment for eating or weight loss.
- •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 or is pregnant or is not using a reliable form of birth control.
- •Reports active suicidal or homicidal ideation.
结局指标
主要结局
Body Mass Index
时间窗: Post-treatment (3 months)
BMI is calculated using measured height and weight- kg/m2.
次要结局
- Eating Disorder Psychopathology(Post-treatment (3 months))
- Depressive Symptoms(Post-treatment (3 months))
- Food Craving(Post-treatment (3 months))
研究者
研究点 (2)
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