We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00760695
Recruitment Status : Completed
First Posted : September 26, 2008
Last Update Posted : May 10, 2013
Information provided by (Responsible Party):
Tine Hylle, 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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Drug: dronabinol Drug: placebo Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Cannabinoid CB1 Receptor Agonist Treatment in Severe Chronic Anorexia Nervosa
Study Start Date : October 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

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 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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760695

Layout table for location information
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Layout table for investigator information
Principal Investigator: Andries Alin, physician Endocrinological Department, Odense University Hospital
Layout table for additonal information
Responsible Party: Tine Hylle, for Alin Andries, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00760695    
Other Study ID Numbers: 033
First Posted: September 26, 2008    Key Record Dates
Last Update Posted: May 10, 2013
Last Verified: May 2013
Keywords provided by Tine Hylle, Odense University Hospital:
anorexia nervosa
weight gain
Additional relevant MeSH terms:
Layout table for MeSH terms
Anorexia Nervosa
Signs and Symptoms, Digestive
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