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

Cannabinoid CB1 Receptor Agonist Treatment in Severe Chronic Anorexia Nervosa

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.

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Drug: dronabinol; Drug: placebo

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; the patients in this arm are receiving 2,5 mg dronabinol twice daily	Drug: dronabinol; tablets, twice daily, for 4 weeks; Other Names: Marinol
Placebo Comparator: B; the patients in this arm are receiving 2,5 mg placebo twice daily	Drug: placebo; tablets, twice daily, for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weight gain	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Eating Disorder Inventory (EDI) scale	4 weeks
Motor and inner restlessness (estimated by accelerometry)	4 weeks
Endocrine parameters	4 weeks

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Principal Investigator: Andries Alin, physician, Endocrinological Department, Odense University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: September 25, 2008
• First Submitted That Met QC Criteria: September 25, 2008
• First Posted (Estimate): September 26, 2008

Study Record Updates

• Last Update Posted (Estimate): May 10, 2013
• Last Update Submitted That Met QC Criteria: May 8, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: chronic; dronabinol; anorexia nervosa; weight gain; EDI
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol
• Other Study ID Numbers: 033