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

Appetite Regulation Clinical Trial

Official title:

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

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

• Appetite Regulation

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