Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain
|Fibromyalgia Back Pain||Behavioral: Operant behavioral treatment; Drug: THC||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
|Official Title:||Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain|
- 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
|Study Start Date:||August 2005|
|Estimated Study Completion Date:||May 2009|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176163
|Principal Investigator:||Justus Benrath, MD, PhD||Heidelberg University|