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

Not Applicable

Active, not recruiting

• Conditions: Appetite Regulation
• Interventions: Drug: Placebo; Drug: dronabinol

• Registration Number: NCT02310347
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-19
• Study Start: 2014-12
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-08
• Primary Completion: 2016-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

For healthy volunteers:

1. 20 ≤ BMI ≤ 25
2. Age 18-60
3. Right handed
4. 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:

1. BMI > 30
2. Age 18-60
3. Right handed
4. 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:

1. FD diagnosis according to 'Rome III' criteria
2. Age 18-60
3. Right handed
4. 5% weight loss since onset of symptoms

Exclusion Criteria

1. 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

2. Psychiatric disorders:

   • Eating disorders
   • Psychotic disorders
   • Major depressive disorder
   • Somatoform disorder

3. 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;

4. Known allergy to dronabinol and/or sesam oil

5. Pregnancy, plans to conceive or refusal to take adequate precaution to avoid pregnancy

6. Subjects who refuse to abstain from driving during the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Empty hard gelatin capsules
Marinol	dronabinol	* generic name: dronabinol * dosage: 0.1 mg/kg * frequency: 2 times a single dose * duration: acute adminstration

Primary Outcome Measures

Name	Time	Method
Behavioural responses to food images and food intake	2 years	Scores on Visual Analogue Scales
Gut peptide responses	2 years	Concentrations of gut peptide levels will be determined using radioimmunoassays

Trial Locations

Locations (1)

University Hospitals Leuven, campus Gasthuisberg; 🇧🇪 Leuven, Belgium