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

This study has been completed.
Sponsor:
Collaborators:
Central Institute of Mental Health, Mannheim
University of Mannheim
Academic City Hospital, Germany
BG Trauma Center Ludwigshafen
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00176163
First received: September 13, 2005
Last updated: February 1, 2010
Last verified: September 2005
History of Changes
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Back Pain
 Behavioral: Operant behavioral treatment; Drug: THC
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain

Resource links provided by NLM:

Drug Information available for: Dronabinol
U.S. FDA Resources

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Impairment by pain

Secondary Outcome Measures:
  • 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
Estimated Enrollment: 240
Study Start Date: August 2005
Estimated Study Completion Date: May 2009
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
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176163

Sponsors and Collaborators
Heidelberg University
Central Institute of Mental Health, Mannheim
University of Mannheim
Academic City Hospital, Germany
BG Trauma Center Ludwigshafen
Investigators
Principal Investigator: Justus Benrath, MD, PhD Heidelberg University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00176163     History of Changes
Other Study ID Numbers: kfg107
Study First Received: September 13, 2005
Last Updated: February 1, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heidelberg University:
Fibromyalgia
Back pain
Behavior Therapy
Operant learning
Tetrahydrocannabinol

Additional relevant MeSH terms:
Back Pain
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
 Neurologic Manifestations
Neuromuscular Diseases
Pain
Rheumatic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on March 03, 2015