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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00176163
• Other study ID #: kfg107
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: February 1, 2010
• Start date: August 2005
• Est. completion date: May 2009

Study information

• Verified date: September 2005
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Operant behavioral treatment; Drug: THC

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Heidelberg University	Academic City Hospital, Germany, BG Trauma Center Ludwigshafen, Central Institute of Mental Health, Mannheim, University of Mannheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impairment by pain
Secondary	Pain intensity
Secondary	physical function and emotional state assessed by questionnaires
Secondary	number of serious adverse events
Secondary	subjective rating of improvement by therapy
Secondary	subjective rating of therapy effectiveness
Secondary	therapy satisfaction rated by patient