Clinical trial NCT00760695: Cannabinoid Receptor (CB1) Agonist Treatment in Severe Chronic Anorexia Nervosa
Official title: Cannabinoid CB1 Receptor Agonist Treatment in Severe Chronic Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anorexia Nervosa
Keywords: anorexia nervosa
chronic
dronabinol
weight gain
EDI
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2008-09-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weight gain
timeFrame: 4 weeks
Secondary outcomes:
measure: Eating Disorder Inventory (EDI) scale
timeFrame: 4 weeks
measure: Motor and inner restlessness (estimated by accelerometry)
timeFrame: 4 weeks
measure: Endocrine parameters
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Endocrinological Department, Odense University Hospital
name: Andries Alin, physician
role: PRINCIPAL_INVESTIGATOR
References: