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

This study has been completed.
Information provided by (Responsible Party):
Tine Hylle, Odense University Hospital Identifier:
First received: September 25, 2008
Last updated: May 8, 2013
Last verified: May 2013

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.

Condition Intervention Phase
Anorexia Nervosa
Drug: dronabinol
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Cannabinoid CB1 Receptor Agonist Treatment in Severe Chronic Anorexia Nervosa

Resource links provided by NLM:

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Weight gain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Eating Disorder Inventory (EDI) scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Motor and inner restlessness (estimated by accelerometry) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Endocrine parameters [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: October 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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
Other Name: 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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00760695

Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Principal Investigator: Andries Alin, physician Endocrinological Department, Odense University Hospital
  More Information

No publications provided

Responsible Party: Tine Hylle, for Alin Andries, Odense University Hospital Identifier: NCT00760695     History of Changes
Other Study ID Numbers: 033
Study First Received: September 25, 2008
Last Updated: May 8, 2013
Health Authority: Denmark: National Board of Health

Keywords provided by Odense University Hospital:
anorexia nervosa
weight gain

Additional relevant MeSH terms:
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents processed this record on April 17, 2014