Cannabinoid CB1 receptor agonist treatment in severe chronic anorexia nervosa

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005631-29-DK

Enrollment

Registered

2008-03-12

Start date

2008-06-18

Completion date

Unknown

Last updated

2021-06-07

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

Conditions

severe chronic Anorexia Nervosa MedDRA version: 9.1 Level: PT Classification code 10002649 Term: Anorexia nervosa

Interventions

Product Name: Marinol Product Code: A04AD10 Pharmaceutical Form: Capsule* INN or Proposed INN: DRONABINOL CAS Number: 1972083 Concentration unit: mg milligram(s) Concentration type: equal Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Patients under treatment for AN. 2 Patients attending ambulatory treatment, which are not expected to be admitted at the hospital with AN-related pathology or discharged during the study period. 3 Patients admitted to Department of Endocrinology M or Psychiatric department P which are not expected to be discharged during the study period. 4 Age over 18. 5 Duration of the disease over 5 years. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1 Patients under compulsory treatment or suffering of mania, schizophrenia or primary depression. 2 Patients with any medical or psychiatric event related or not related to the underlying eating disorder which requires prolonged admission to the hospital during the study. 3 Patients with unstable heart disease (relevant changes in medication prior or during the study) and limitation of activity (not comfortable with more than moderate exertion / at rest). 4 Patients not attending to the weekly controls. 5 If other severe adverse events (SAE) / drug reactions (SADR) are suspected. 6 Patients actually having or having a history of alcohol, cannabis, opioids or central stimulating drugs abuse. 7 Patients with known allergy to dronabinol or sesam oil. 8 Fertile, menstruating women not using safe contraception*. 9 Pregnancy. * - Patients with chronic AN have per definition amenorrhea and seldom vita sexualis.

Design outcomes

Primary

Measure	Time frame
Main Objective: To reveal through a pilot trial if treatment of patients with severe chronic Anorexia Nervosa with cannabinoid type 1 receptor agonist has significant effect on weight ;Secondary Objective: To reveal through a pilot trial if treatment of patients with severe chronic Anorexia Nervosa with cannabinoid type 1 receptor agonist has significant effect on: • Weight gain (primary endpoint) • Eating Disorder Inventory (EDI) scale • Motor and inner restlessness (estimated by accelerometry) • Endocrine parameters ;Primary end point(s): Weight gain on Marinol (dronabinol / cannabinoid type 1 receptor agonist) therapy	—

Measure

Time frame

Main Objective: To reveal through a pilot trial if treatment of patients with severe chronic Anorexia Nervosa with cannabinoid type 1 receptor agonist has significant effect on weight ;Secondary Objective: To reveal through a pilot trial if treatment of patients with severe chronic Anorexia Nervosa with cannabinoid type 1 receptor agonist has significant effect on: • Weight gain (primary endpoint) • Eating Disorder Inventory (EDI) scale • Motor and inner restlessness (estimated by accelerometry) • Endocrine parameters ;Primary end point(s): Weight gain on Marinol (dronabinol / cannabinoid type 1 receptor agonist) therapy

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Countries

Denmark

Outcome results

None listed

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