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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
Sponsor:
Information provided by (Responsible Party):
Tine Hylle, Odense University Hospital

Tracking Information
First Submitted Date  ICMJE September 25, 2008
First Posted Date  ICMJE September 26, 2008
Last Update Posted Date May 10, 2013
Study Start Date  ICMJE October 2008
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2008)
Weight gain [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabinoid Receptor (CB1) Agonist Treatment in Severe Chronic Anorexia Nervosa
Official Title  ICMJE Cannabinoid CB1 Receptor Agonist Treatment in Severe Chronic Anorexia Nervosa
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Anorexia Nervosa
Intervention  ICMJE
  • Drug: dronabinol
    tablets, twice daily, for 4 weeks
    Other Name: Marinol
  • Drug: placebo
    tablets, twice daily, for 4 weeks
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2008)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00760695
Other Study ID Numbers  ICMJE 033
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Tine Hylle, Odense University Hospital
Original Responsible Party Alin Andries, Department of Endocrinology, Odense University Hospital
Current Study Sponsor  ICMJE Odense University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andries Alin, physician Endocrinological Department, Odense University Hospital
PRS Account Odense University Hospital
Verification Date May 2013

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