Anorexia Nervosa
Conditions
Keywords
anorexia nervosa, chronic, dronabinol, weight gain, EDI
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.
Interventions
DRUGplacebo
tablets, twice daily, for 4 weeks
DRUGdronabinol
tablets, twice daily, for 4 weeks
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight gain | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Eating Disorder Inventory (EDI) scale | 4 weeks |
| Motor and inner restlessness (estimated by accelerometry) | 4 weeks |
| Endocrine parameters | 4 weeks |
Countries
Denmark
Outcome results
None listed