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NCT Number: NCT02310347

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven, campus Gasthuisberg

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For healthy volunteers:

  • 20 ≤ 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
  • 5% weight loss since onset of symptoms

Exclusion criteria

  • 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;
  • Known allergy to dronabinol and/or sesam oil
  • Pregnancy, plans to conceive or refusal to take adequate precaution to avoid pregnancy
  • Subjects who refuse to abstain from driving during the study

Treatment and study plan

Dronabinol

Drug

Placebo

Drug

Primary outcomes

  1. Behavioural responses to food images and food intake

    Time frame: 2 years

    Scores on Visual Analogue Scales

  2. Gut peptide responses

    Time frame: 2 years

    Concentrations of gut peptide levels will be determined using radioimmunoassays

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2025
First posted
Dec 8, 2014
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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