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

Anorexia Nervosa Clinical Trial

Official title: Cannabinoid CB1 Receptor Agonist Treatment in Severe Chronic Anorexia Nervosa

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

• NCT number: NCT00760695
• Study type: Interventional
• Source: Odense University Hospital
• Status: Completed
• Phase: Phase 3
• Start date: October 2008
• Completion date: December 2011