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

NCT ID: NCT02310347

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2025-10-31

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.

Conditions

Appetite Regulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Marinol

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

Group Type: EXPERIMENTAL

dronabinol

Intervention Type: DRUG

Placebo

Empty hard gelatin capsules

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

dronabinol

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lukas Van Oudenhove, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Leuven, campus Gasthuisberg

Locations

University Hospitals Leuven, campus Gasthuisberg

Leuven, , Belgium

Countries

Belgium

References

Weltens N, Depoortere I, Tack J, Van Oudenhove L. Effect of acute Delta9-tetrahydrocannabinol administration on subjective and metabolic hormone responses to food stimuli and food intake in healthy humans: a randomized, placebo-controlled study. Am J Clin Nutr. 2019 Apr 1;109(4):1051-1063. doi: 10.1093/ajcn/nqz007.

Reference Type: DERIVED

PMID: 30949710 (View on PubMed)

Other Identifiers

2012-003017-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

S54673

Identifier Type: -

Identifier Source: org_study_id