NCT00760695

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

Cannabinoid CB1 Receptor Agonist Treatment in Severe Chronic Anorexia Nervosa

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The goals of this study are to reveal through a pilot trial if treatment of patients with severe chronic AN with Marinol® (dronabinol, a CB1 agonist) has significant effect on: * Weight * Eating Disorder Inventory (EDI) scale * Motor and inner restlessness (estimated by accelerometry) * Endocrine parameters (see below, paragraph 4.4) This study is a randomized, double blinded, placebo controlled cross over study. 24 patients with chronic AN meeting the inclusion criteria will be randomized either to receive Marinol® or placebo. After four weeks the two groups will undergo a wash-out period and after that will receive the opposite therapeutic regime for another four weeks.

Conditions

• Anorexia Nervosa

Interventions

Type	Name	Description
DRUG	dronabinol	tablets, twice daily, for 4 weeks
DRUG	placebo	tablets, twice daily, for 4 weeks

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2008-09-26
• Last updated: 2013-05-10

Locations

1 site across 1 country: Denmark