The Quantification of Ingestive Behavior
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Food Intake
研究概览
简要总结
The goal of this study is to determine whether one week of phentermine compared to placebo administration results in changes in food intake during a laboratory meal.
详细描述
This study aims to explore whether short-term measures of eating behavior can be related to later, longer-term weight loss. In a double-blind, randomized fashion, participants will be asked to take study medication for three weeks: one week of phentermine and two weeks of placebo. At the end of the first and third weeks, participants will be asked to participate in a range of eating behavior studies. Following this three-week, double-blind phase, participants will be offered 6 months of open treatment for weight loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI between 30-40kg/m2
- •Stable weight (+5 lbs) for a minimum of 3 months
- •Systolic Blood Pressure <140mm Hg
- •Diastolic Blood Pressure <90 mm Hg
- •Pulse <95 beats per minute
- •English language proficiency
排除标准
- •Previous unsuccessful trial of phentermine
- •Prior adverse reaction to phentermine
- •On any antidepressant medications,especially monoamine oxidase inhibitors(MAOI)
- •History of neurological disorder (e.g. dementia)
- •History of moderate or severe head injury
- •Current or past history of coronary artery disease
- •Current or past history of stroke or transient ischemic attack
- •Current or past history of heart arrhythmias
- •Current of past history of congestive heart failure
- •Current or past history of peripheral artery disease
- •Current or past history of liver disease
- •Current or past history of kidney disease
- •Uncontrolled diabetes mellitus (type I or II)
- •Narrow-angle glaucoma
- •Hypo- or hyper-thyroidism not adequately treated
- •On medications (prescribed or OTC) known to affect appetite (e.g. diet pills), weight, or metabolism
- •Current or past history (within the past 12 months) of major depression
- •Current or past history (past 12 months) of alcohol or drug abuse or dependence
- •Current or past history (lifetime) of amphetamine abuse or dependence
- •Known history of learning disorder or developmental disability
- •Current or past Attention Deficit Hyperactivity Disorder (ADHD)
- •Pregnancy, planning to become pregnant, or lactation within the previous 6 months
- •Waist circumference greater than 188cm
- •Indwelling metallic object (e.g., pacemaker,pump), non-removable metal jewelry, medicinal patch or recent metallic ink tattoo
- •Significant claustrophobia
- •Current or past history of anorexia nervosa,bulimia nervosa (within the past 12 months) or binge eating disorder (within the previous 6 months)
研究组 & 干预措施
37.5 mg Phentermine daily for 7 days
In this arm, participants receive 37.5mg phentermine for one week followed by 2 weeks of placebo.
Other names for phentermine:
adipex ionamin
干预措施: Phentermine (Drug)
Placebo (for phentermine 37.5mg)
In this arm, participants receive Placebo (for 37.5mg phentermine) for two weeks followed by phentermine 37.5mg for 7 days.
干预措施: placebo (Drug)
结局指标
主要结局
Food Intake
时间窗: one week
The primary outcome measure is food intake assessed by laboratory meal study after one week of phentermine administration compared to one week of placebo administration.
次要结局
未报告次要终点