Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain

Heidelberg University

Status and phase

Completed

Phase 2

Conditions

Fibromyalgia

Back Pain

Treatments

Behavioral: Operant behavioral treatment; Drug: THC

Study type

Interventional

Funder types

Other

Identifiers

NCT00176163

kfg107

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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