Influence of a Medicinal Cannabinoid Agonist on Responses to Food Images and Food Intake

Study Overview
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Brief Summary
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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.

Official Title
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Influence of a Medicinal Cannabinoid Agonist on Behavioural Responses to Food Images and Food Intake: Role of Gut Peptides

Conditions
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Appetite Regulation

Intervention / Treatment
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* Drug: dronabinol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For healthy volunteers: 20 ≤ BMI ≤ 25 Age 18-60 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: BMI > 30 Age 18-60 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 Age 18-60 Right handed 5% weight loss since onset of symptoms Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Marinol<br>generic name: dronabinol dosage: 0.1 mg/kg frequency: 2 times a single dose duration: acute adminstration | Drug: dronabinol<br> <br> |
| Placebo Comparator: Placebo<br>Empty hard gelatin capsules | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioural responses to food images and food intake | Scores on Visual Analogue Scales | 2 years | 
| Gut peptide responses | Concentrations of gut peptide levels will be determined using radioimmunoassays | 2 years |