Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176163
Status:
COMPLETED
Last Update Posted:
2010-02-02
First Post:
2005-09-13
Brief Title:
Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is known that a so called pain memory usually evolves in chronic pain syndromes which both aggravates the disorder and modifies the patients pain perception Thus the principal object of pain therapy is to delete this dysfunctional pain memory The combination of medication physiotherapy and psychological therapy seems to be the most effective treatment This study investigates the effect of a concomitant Dronabinol medication Cannabinoid on the effectiveness of behavioral therapy It is hypothesized that the combination of behavioral therapy and Dronabinol will be most effective in deleting the pain memory
Detailed Description:
This study investigates the combination of operant behavioral treatment and Cannabinoid medication in patients with fibromyalgia and patients with back pain It is well known that cannabinoids THC accelerate learning processes It is assumed that the combination of both treatments may exert an synergetic effect A low dose of THC is used which ist not expected to have direct analgetic effects The study also investigates genetic determinants of both disorders and the response to treatment respectively
The patients will be randomly assigned to one of four groups Behavioral therapy and Dronabinol behavioral therapy and placebo behavioral therapy only standard medical therapy Patients will attend 12 weekly group-sessions 6-8 patients of behavioral therapy Behavioral therapy sessions will include training in reducing pain behaviour and establishing active and healthy behaviour instead There will be weekly medical safety visits in which the patients receive medication and undergo a physical examination blood and urine samples
Patients will be evaluated before and after behavioral therapy and will be followed for an additional 6- and 12-months phase The outcome variables will be recorded by the use of interviews and questionnaires
The patients will be randomly assigned to one of four groups Behavioral therapy and Dronabinol behavioral therapy and placebo behavioral therapy only standard medical therapy Patients will attend 12 weekly group-sessions 6-8 patients of behavioral therapy Behavioral therapy sessions will include training in reducing pain behaviour and establishing active and healthy behaviour instead There will be weekly medical safety visits in which the patients receive medication and undergo a physical examination blood and urine samples
Patients will be evaluated before and after behavioral therapy and will be followed for an additional 6- and 12-months phase The outcome variables will be recorded by the use of interviews and questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None