Cannabinoid Receptor (CB1) Agonist Treatment in Severe Ch... | NCT00760695

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

NCT00760695

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

May 10, 2013Estimated

Enrollment

24Actual

Phase

Phase 3

Conditions

Anorexia Nervosa

Interventions

dronabinol
placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Sep 25, 2008

First Submission Date that Met QC Criteria

Sep 25, 2008

First Posted Date

Sep 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2013

Last Update Posted Date

May 10, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	the patients in this arm are receiving 2,5 mg dronabinol twice daily	Drug: dronabinol
B	Placebo Comparator	the patients in this arm are receiving 2,5 mg placebo twice daily	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dronabinol	Drug	tablets, twice daily, for 4 weeks	A	Marinol

Measure	Description	Time Frame
Weight gain		4 weeks

Measure	Description	Time Frame
Eating Disorder Inventory (EDI) scale		4 weeks
Motor and inner restlessness (estimated by accelerometry)		4 weeks
Endocrine parameters

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Andries Alin, physician	Endocrinological Department, Odense University Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital		Odense		5000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D000856	Anorexia Nervosa
D000092122	Bronchiolitis Obliterans Syndrome
D015430	Weight Gain

Ancestor Terms

ID	Term
D001068	Feeding and Eating Disorders
D001523	Mental Disorders
D000092124	Organizing Pneumonia
D001989	Bronchiolitis Obliterans

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D002186	Cannabinoids
D013729	Terpenes
D006838	Hydrocarbons
D009930	Organic Chemicals