Cognitive-Behavioral and Pharmacologic Treatment of Binge-Eating Disorder and Obesity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in Binge-Eating Frequency
研究概览
简要总结
This study will test the relative efficacy and effectiveness of the combination of naltrexone and bupropion (NB) medication as a treatment for binge-eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst non-responders to acute treatments, NB medication results in superior outcomes compared with placebo.
详细描述
Obesity is a heterogeneous problem and research has highlighted the particular significance of a subgroup with binge-eating disorder (BED), the most prevalent formal eating disorder. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study RCT will provide new and novel findings from a controlled test, amongst non-responders to acute treatments, whether Naltrexone/Bupropion medication results in superior and longer-term outcomes than placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 64 years old
- •Meets DSM-5 criteria for binge-eating disorder
- •BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and <50
- •Medically cleared as determined by EKG and medical record review
- •Available for the duration of the treatment and follow-up (18 months)
- •Read, comprehend, and write English at a sufficient level to complete study-related materials
- •Able to travel to study location (New Haven, CT) for weekly visits
排除标准
- •Previous history of problems with LDX or other stimulants
- •Current psychostimulant use or use of any medication for ADHD
- •Current use of study medications: LDX (Vyvanse), Bupropion (Wellbutrin, Zyban), Naltrexone, or Contrave
- •History of congenital heart disease, known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, cerebrovascular pathology including stroke, exertional chest pain, uncontrolled high blood pressure, and other serious heart problems.
- •History of severe renal, hepatic, neurological, or chronic pulmonary disease or other serious, unstable medical disorder.
- •Current uncontrolled hypertension
- •Current uncontrolled type I or II diabetes mellitus
- •Current uncontrolled thyroid illness
- •Gallbladder disease
- •Co-occurring severe mental illness requiring hospitalization or intensive treatment
- •Endorses current active suicidal or homicidal ideation with intent or plan
- •History or current alcohol or substance use disorder (smoking is not exclusionary)
- •Predisposition to seizures
- •History of anorexia nervosa or bulimia nervosa, or currently regularly self-inducing vomiting
- •Currently taking MAOI, SSRI or strong inhibitors of CYP2D6
- •History of allergy or sensitivity to the study medication or stimulant medications
- •Current use of medications contraindicated with the study medications
- •Currently breast feeding or pregnant, or not willing to use reliable form of contraception
- •Currently taking opioid pain medications or drugs
- •Currently using effective treatment (evidence-based therapeutic or psychopharmacologic) for eating and/or weight loss
- •Currently participating in another clinical study in which the participant is or will be exposed to an investigational or a non-investigational drug or device
- •Medical status judged by study physician as contraindication
研究组 & 干预措施
Naltrexone/Bupropion
干预措施: Naltrexone and Bupropion (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change in Binge-Eating Frequency
时间窗: From baseline interview at study enrollment to 3 months after the 12-week treatment.
Binge-eating frequency is a continuous variable of binge-eating episodes assessed using interview (Eating Disorder Examination interview). The Eating Disorder Examination uses a 28 day recall of eating behavior. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) defines binge-eating as "eating, in a discrete period of time an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances and a sense of loss of control over eating during the episode." The number of episodes that meet this description will be counted and totaled.
Change in Binge-Eating Frequency
时间窗: From post-treatment to the 6-month follow-up
Binge-eating frequency is a continuous variable of binge-eating episodes assessed using interview (Eating Disorder Examination interview). The Eating Disorder Examination uses a 28 day recall of eating behavior. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) defines binge-eating as "eating, in a discrete period of time an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances and a sense of loss of control over eating during the episode." The number of episodes that meet this description will be counted and totaled.
Percent Change in Weight
时间窗: From baseline interview at study enrollment to 3 months after the 12-week treatment.
Negative values indicate weight loss and positive values indicate weight gain.
Percent Change in Weight
时间窗: From post-treatment to the 6-month follow-up
Negative values indicate weight loss and positive values indicate weight gain.
Change in Binge-Eating Frequency
时间窗: From post-treatment to the 12-month follow-up
Binge-eating frequency is a continuous variable of binge-eating episodes assessed using interview (Eating Disorder Examination interview). The Eating Disorder Examination uses a 28 day recall of eating behavior. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) defines binge-eating as "eating, in a discrete period of time an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances and a sense of loss of control over eating during the episode." The number of episodes that meet this description will be counted and totaled.
Percent Change in Weight
时间窗: From post-treatment to the 12-month follow-up
Negative values indicate weight loss and positive values indicate weight gain.
次要结局
- Binge-Eating Remission(12-month follow-up)
- Change in Eating-Disorder Psychopathology (Continuous)(From post-treatment to the 12-month follow-up)
- Change in Depressive Symptoms(From post-treatment to the 12-month follow-up)
- Binge-Eating Remission(12-weeks)
- Binge-Eating Remission(6-month follow-up)
- Change in Eating-Disorder Psychopathology (Continuous)(From baseline interview at study enrollment to 3 months after the 12-week treatment.)
- Change in Eating-Disorder Psychopathology (Continuous)(From post-treatment to the 6-month follow-up)
- Change in Depressive Symptoms(From baseline interview at study enrollment to 3 months after the 12-week treatment.)
- Change in Depressive Symptoms(From post-treatment to the 6-month follow-up)