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

NCT02310347 | Active Not Recruiting

• 2 other identifiers: S546732012-003017-33
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Marinol

EXPERIMENTAL

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

Drug: dronabinol

Placebo

PLACEBO COMPARATOR

Empty hard gelatin capsules

Drug: Placebo

Interventions

dronabinol DRUG

Marinol

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For healthy volunteers:
• ≤ BMI ≤ 25
• Age 18-60
• Right handed
• 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:
• BMI \> 30
• Age 18-60
• Right handed
• 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:
• FD diagnosis according to 'Rome III' criteria
• Age 18-60
• Right handed
• % weight loss since onset of symptoms

You may not qualify if:

• 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
• Psychiatric disorders:
• Eating disorders
• Psychotic disorders
• Major depressive disorder
• Somatoform disorder
• 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;

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven, campus Gasthuisberg

Leuven, 3000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 30949710 DERIVED

MeSH Terms

Interventions

Dronabinol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Lukas Van Oudenhove, MD, PhD

  University Hospitals Leuven, campus Gasthuisberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: December 8, 2014
• Study Start: December 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

BE (1)