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

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
dronabinol
placebo
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring anorexia nervosa, chronic, dronabinol, weight gain, EDI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Weight gain

Secondary Outcome Measures

Eating Disorder Inventory (EDI) scale
Motor and inner restlessness (estimated by accelerometry)
Endocrine parameters

Full Information

First Posted
September 25, 2008
Last Updated
May 8, 2013
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00760695
Brief Title
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

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
anorexia nervosa, chronic, dronabinol, weight gain, EDI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
the patients in this arm are receiving 2,5 mg dronabinol twice daily
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
the patients in this arm are receiving 2,5 mg placebo twice daily
Intervention Type
Drug
Intervention Name(s)
dronabinol
Other Intervention Name(s)
Marinol
Intervention Description
tablets, twice daily, for 4 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
tablets, twice daily, for 4 weeks
Primary Outcome Measure Information:
Title
Weight gain
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Eating Disorder Inventory (EDI) scale
Time Frame
4 weeks
Title
Motor and inner restlessness (estimated by accelerometry)
Time Frame
4 weeks
Title
Endocrine parameters
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andries Alin, physician
Organizational Affiliation
Endocrinological Department, Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

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

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