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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
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, 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 Tine Hylle, Odense University Hospital:

Primary Outcome Measures:
  • Weight gain [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Eating Disorder Inventory (EDI) scale [ Time Frame: 4 weeks ]
  • Motor and inner restlessness (estimated by accelerometry) [ Time Frame: 4 weeks ]
  • Endocrine parameters [ Time Frame: 4 weeks ]

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

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   (Adult, Senior)
Sexes Eligible for Study:   All
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.
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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

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

Keywords provided by Tine Hylle, Odense University Hospital:
anorexia nervosa
weight gain

Additional relevant MeSH terms:
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 25, 2017