Mechanistic investigation of the interaction between the endocannabinoid system and gut peptides in healthy volunteers and food intake disorders.

Influence of a medicinal cannabinoid agonist on behavioural responses to food images and food intake: role of gut peptides

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003017-33-BE

Enrollment

Registered

2012-10-10

Start date

2012-12-18

Completion date

Unknown

Last updated

2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 14.1 Level: HLT Classification code 10003022 Term: Appetite disorders System Organ Class: 100000004861

Interventions

Trade Name: Marinol Product Name: Marinol Pharmaceutical Form: Capsule INN or Proposed INN: DRONABINOL CAS Number: 1972-08-3 Concentration unit: mg milligram(s) Concentration type: range Concentration

Eligibility

Sex/Gender

All

Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine the influence of a medicinal cannabinoid agonist versus placebo on behavioural and gut peptide responses to food images and food intake.;Secondary Objective: Not applicable.;Primary end point(s): To demonstrate whether the interaction between the endocannabinoid system and gut peptides is involved in the regulation of appetite and ingestive behaviour. ;Timepoint(s) of evaluation of this end point: After intake of Marinol.	—

Measure

Time frame

Main Objective: To examine the influence of a medicinal cannabinoid agonist versus placebo on behavioural and gut peptide responses to food images and food intake.;Secondary Objective: Not applicable.;Primary end point(s): To demonstrate whether the interaction between the endocannabinoid system and gut peptides is involved in the regulation of appetite and ingestive behaviour. ;Timepoint(s) of evaluation of this end point: After intake of Marinol.

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.	—

Countries

Belgium

Contacts

Public ContactTARGID

KULeuven

+3216330180

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026