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

NCT ID: NCT00760695

Last Updated: 2013-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-12-31

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.

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A

the patients in this arm are receiving 2,5 mg dronabinol twice daily

Group Type: ACTIVE_COMPARATOR

dronabinol

Intervention Type: DRUG

tablets, twice daily, for 4 weeks

B

the patients in this arm are receiving 2,5 mg placebo twice daily

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

tablets, twice daily, for 4 weeks

Interventions

dronabinol

tablets, twice daily, for 4 weeks

Intervention Type: DRUG

placebo

tablets, twice daily, for 4 weeks

Intervention Type: DRUG

Other Intervention Names

Marinol

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tine Hylle

for Alin Andries

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andries Alin, physician

Role: PRINCIPAL_INVESTIGATOR

Endocrinological Department, Odense University Hospital

Locations

Odense University Hospital

Odense, , Denmark

Countries

Denmark

Other Identifiers

033

Identifier Type: -

Identifier Source: org_study_id