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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tine Hylle, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00760695
First received: September 25, 2008
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

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:

Drug Information available for: Dronabinol
U.S. FDA Resources

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.
  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00760695

Locations
Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
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
ClinicalTrials.gov 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
chronic
dronabinol
weight gain
EDI

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders
Tetrahydrocannabinol
Hallucinogens
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013