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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Appetite Regulation
• Intervention / Treatment: Drug: Placebo; Drug: dronabinol

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospitals Leuven, Campus Gasthuisberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Marinol; generic name: dronabinol; dosage: 0.1 mg/kg; frequency: 2 times a single dose; duration: acute adminstration	Drug: dronabinol
Placebo Comparator: Placebo; Empty hard gelatin capsules	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioural responses to food images and food intake	Scores on Visual Analogue Scales	2 years
Gut peptide responses	Concentrations of gut peptide levels will be determined using radioimmunoassays	2 years

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Lukas Van Oudenhove, MD, PhD, University Hospitals Leuven, Campus Gasthuisberg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: November 19, 2014
• First Submitted That Met QC Criteria: December 3, 2014
• First Posted (Estimated): December 8, 2014

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol
• Other Study ID Numbers: S54673; 2012-003017-33 (EudraCT Number)