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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
tablets, twice daily, for 4 weeks
tablets, twice daily, for 4 weeks
Odense University Hospital
Odense, Denmark
Weight gain
Time frame: 4 weeks
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
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