Status:
COMPLETED
Cannabinoid Receptor (CB1) Agonist Treatment in Severe Chronic Anorexia Nervosa
Lead Sponsor:
Odense University Hospital
Conditions:
Anorexia Nervosa
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 Seco...
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 Diso...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00760695
Start Date
October 1 2008
End Date
December 1 2011
Last Update
May 10 2013
Active Locations (1)
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1
Odense University Hospital
Odense, Denmark, 5000