Clinical trial NCT00176163: Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain
Official title: Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia
Back Pain
Keywords: Fibromyalgia
Back pain
Behavior Therapy
Operant learning
Tetrahydrocannabinol
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Central Institute of Mental Health, Mannheim
name: University of Mannheim
name: Academic City Hospital, Germany
name: BG Trauma Center Ludwigshafen
First posted: 2005-09-15
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Fibromyalgia meeting ACR-criteria
* Diagnosis of chronic back pain
* Pain duration exceeding 3 months
* Age between 18 and 70 years
* The patient has been informed about the study, understood the information and signed the informed consent form

Exclusion Criteria:

* Tumors, fractures and heavy osteoporosis
* Secondary back pain at arthrosis or degenerative scoliosis
* Radicular back pain
* Other pain syndrome is main problem
* Opiate medication \> 60mg morphine per diem
* Addiction (drugs, alcohol, medicaments)
* Cardiac insufficiency \> NYHA II
* Exercise induced dyspnea, Angina pectoris A detailed version of exclusion criteria: see study protocol

Primary outcomes:
measure: Impairment by pain
Secondary outcomes:
measure: Pain intensity
measure: physical function and emotional state assessed by questionnaires
measure: number of serious adverse events
measure: subjective rating of improvement by therapy
measure: subjective rating of therapy effectiveness
measure: therapy satisfaction rated by patient
Other outcomes:
Locations:
Study officials:
affiliation: Heidelberg University
name: Justus Benrath, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Finnern MM, Kleinbohl D, Flor H, Benrath J, Holzl R. Deconstructing chronicity of musculoskeletal pain: intensity-duration relations, minimal dimensions and clusters of chronicity. Scand J Pain. 2018 Jul 26;18(3):363-377. doi: 10.1515/sjpain-2018-0021.