Cannabinoid Receptor (CB1) Agonist Treatment in Severe Chronic Anorexia Nervosa

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A pilot study designed to reveal the effects of Marinol / dronabinol, a CB 1 agonist.

Primary end point: To estimate weight gain and EDI scores in patients receiving Marinol compared to placebo

Secondary end points: Motor and inner restlessness and hormonal changes during the treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Odense University Hospital
• Treatments: Dronabinol

Criteria

Inclusion Criteria:

• Patients under treatment for AN.

• Patients attending ambulatory treatment, which are not expected to be admitted at the hospital with AN-related pathology or discharged during the study period.

• Patients admitted to Department of Endocrinology M or Psychiatric Department P which are not expected to be discharged during the study period.

• Age over 18.

• Duration of the disease over 5 years.

Exclusion Criteria:

• Patients under compulsory treatment or suffering of mania, schizophrenia or primary depression.

• 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.

• 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).

• Patients not attending to the weekly controls.

• If other severe adverse events (SAE) / drug reactions (SADR) are suspected.

• Patients actually having or having a history of alcohol, cannabis, opioids or central stimulating drugs abuse.

• Patients with known allergy to dronabinol or sesame oil.

• Fertile, menstruating women not using safe contraception.

• Pregnancy.