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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

September 25, 2008
May 8, 2013
October 2008
December 2011   (final data collection date for primary outcome measure)
Weight gain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00760695 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Anorexia Nervosa
  • Drug: dronabinol
    tablets, twice daily, for 4 weeks
    Other Name: Marinol
  • Drug: placebo
    tablets, twice daily, for 4 weeks
    Other Name: placebo
  • Active Comparator: A
    the patients in this arm are receiving 2,5 mg dronabinol twice daily
    Intervention: Drug: dronabinol
  • Placebo Comparator: B
    the patients in this arm are receiving 2,5 mg placebo twice daily
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00760695
033
Yes
Tine Hylle, Odense University Hospital
Odense University Hospital
Not Provided
Principal Investigator: Andries Alin, physician Endocrinological Department, Odense University Hospital
Odense University Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP