Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain
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|ClinicalTrials.gov Identifier: NCT00176163|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 2, 2010
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia Back Pain||Behavioral: Operant behavioral treatment; Drug: THC||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain|
|Study Start Date :||August 2005|
|Study Completion Date :||May 2009|
- Impairment by pain
- Pain intensity
- physical function and emotional state assessed by questionnaires
- number of serious adverse events
- subjective rating of improvement by therapy
- subjective rating of therapy effectiveness
- therapy satisfaction rated by patient
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00176163
|Principal Investigator:||Justus Benrath, MD, PhD||Heidelberg University|