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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310347
Recruitment Status : Unknown
Verified October 2016 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Active, not recruiting
First Posted : December 8, 2014
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
Appetite Regulation Drug: dronabinol Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Influence of a Medicinal Cannabinoid Agonist on Behavioural Responses to Food Images and Food Intake: Role of Gut Peptides
Study Start Date : December 2014
Actual Primary Completion Date : September 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

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



Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310347


Locations
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Belgium
University Hospitals Leuven, campus Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Lukas Van Oudenhove, MD, PhD University Hospitals Leuven, campus Gasthuisberg
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02310347    
Other Study ID Numbers: S54673
2012-003017-33 ( EudraCT Number )
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists