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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00760695
• Other study ID #: 033
• Status: Completed
• Phase: Phase 3
• First received: September 25, 2008
• Last updated: May 8, 2013
• Start date: October 2008
• Est. completion date: December 2011

Study information

• Verified date: May 2013
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Drug:
• dronabinol
tablets, twice daily, for 4 weeks
• placebo
tablets, twice daily, for 4 weeks

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight gain		4 weeks	No
Secondary	Eating Disorder Inventory (EDI) scale		4 weeks	No
Secondary	Motor and inner restlessness (estimated by accelerometry)		4 weeks	No
Secondary	Endocrine parameters		4 weeks	No