Cannabinoid Receptor (CB1) Agonist Treatment in Severe Chronic Anorexia Nervosa

• 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 ]

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.

• 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

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.