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

Phase 3

Completed

• Conditions: Anorexia Nervosa
• Interventions: Drug: dronabinol; Drug: placebo

• Registration Number: NCT00760695
• Lead Sponsor: Odense University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-25
• Study First Posted: 2008-09-26
• Study Start: 2008-10
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-08
• Last Update Posted: 2013-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	dronabinol	the patients in this arm are receiving 2,5 mg dronabinol twice daily
B	placebo	the patients in this arm are receiving 2,5 mg placebo twice daily

Primary Outcome Measures

Name	Time	Method
Weight gain	4 weeks

Secondary Outcome Measures

Name	Time	Method
Eating Disorder Inventory (EDI) scale	4 weeks
Motor and inner restlessness (estimated by accelerometry)	4 weeks
Endocrine parameters	4 weeks

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark