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

Universitaire Ziekenhuizen KU Leuven

Status: Active, not recruiting

Conditions: Appetite Regulation

Treatments: Drug: Placebo; Drug: dronabinol

Study type: Interventional

Funder types: Other

Identifiers

NCT02310347

S54673

2012-003017-33 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 2 patient groups, including a placebo group

Marinol

Experimental group

Description:

* generic name: dronabinol * dosage: 0.1 mg/kg * frequency: 2 times a single dose * duration: acute adminstration

Treatment:

Drug: dronabinol

Placebo

Placebo Comparator group

Description:

Empty hard gelatin capsules

Treatment:

Drug: Placebo