NCT02310347进行中（未招募）不适用
Influence of a Medicinal Cannabinoid Agonist on Behavioural Responses to Food Images and Food Intake: Role of Gut Peptides
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Behavioural responses to food images and food intake
研究概览
简要总结
The purpose of this study is to examine the influence of a medicinal cannabinoid agonist versus placebo on behavioural and gut peptide responses to food images and food intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For healthy volunteers:
- •20 ≤ BMI ≤ 25
- •Right handed
- •Stable body weight for at least 3 consecutive months at start of study and no history of behavioural, therapeutic or surgical treatment aiming at or leading to weight loss/gain
- •For obese subjects:
- •Right handed
- •Stable body weight for at least 3 consecutive months at start of the study and no behavioural, therapeutic or surgical treatment aiming at or leading to weight loss/gain for at least 3 consecutive months
- •For FD patients:
- •FD diagnosis according to 'Rome III' criteria
- •Right handed
- •5% weight loss since onset of symptoms
排除标准
- •Medical conditions (current or history):
- •Abdominal/thoracic surgery except appendectomy
- •Gastrointestinal, endocrine (especially diabetes), or neurological diseases
- •Cardiovascular, respiratory, renal or urinary diseases
- •Hypertension
- •Food or drug allergies
- •Head trauma with loss of consciousness
- •Psychiatric disorders:
- •Eating disorders
- •Psychotic disorders
- •Major depressive disorder
- •Somatoform disorder
- •Medication use:
- •No history of cannabis use or any other drug of abuse for at least 12 months prior to the study
- •All medication except oral contraception;
- •Known allergy to dronabinol and/or sesam oil
- •Pregnancy, plans to conceive or refusal to take adequate precaution to avoid pregnancy
- •Subjects who refuse to abstain from driving during the study
研究组 & 干预措施
Marinol
Experimental
- generic name: dronabinol
- dosage: 0.1 mg/kg
- frequency: 2 times a single dose
- duration: acute adminstration
干预措施: dronabinol (Drug)
Placebo
Placebo Comparator
Empty hard gelatin capsules
干预措施: Placebo (Drug)
结局指标
主要结局
Behavioural responses to food images and food intake
时间窗: 2 years
Scores on Visual Analogue Scales
Gut peptide responses
时间窗: 2 years
Concentrations of gut peptide levels will be determined using radioimmunoassays
次要结局
未报告次要终点
研究者
研究点 (1)
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