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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02310347
Other study ID # S54673
Secondary ID 2012-003017-33
Status Active, not recruiting
Phase N/A
First received November 19, 2014
Last updated October 25, 2016
Start date December 2014
Est. completion date April 2017

Study information

Verified date October 2016
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 18
Est. completion date April 2017
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
dronabinol

Placebo


Locations

Country Name City State
Belgium University Hospitals Leuven, campus Gasthuisberg Leuven

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Behavioural responses to food images and food intake Scores on Visual Analogue Scales 2 years No
Primary Gut peptide responses Concentrations of gut peptide levels will be determined using radioimmunoassays 2 years No
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