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

NCT ID: NCT00176163

Last Updated: 2010-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2009-05-31

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.

Conditions

Fibromyalgia; Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Operant behavioral treatment; Drug: THC

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role: collaborator

University of Mannheim

OTHER

Sponsor Role: collaborator

Academic City Hospital, Germany

OTHER

Sponsor Role: collaborator

BG Trauma Center Ludwigshafen

OTHER

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: lead

Principal Investigators

Justus Benrath, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

References

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.

Reference Type: DERIVED

PMID: 29870396 (View on PubMed)

Other Identifiers

kfg107

Identifier Type: -

Identifier Source: org_study_id