Status:
ACTIVE_NOT_RECRUITING
Influence of a Medicinal Cannabinoid Agonist on Responses to Food Images and Food Intake
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Appetite Regulation
Eligibility:
All Genders
18-60 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02310347
Start Date
December 1 2014
End Date
October 1 2025
Last Update
July 10 2024
Active Locations (1)
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1
University Hospitals Leuven, campus Gasthuisberg
Leuven, Belgium, 3000