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

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ClinicalTrials.gov Identifier: NCT00176163
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 2, 2010
Sponsor:
Collaborators:
Central Institute of Mental Health, Mannheim
University of Mannheim
Academic City Hospital, Germany
BG Trauma Center Ludwigshafen
Information provided by:
Heidelberg University

Study Description
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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.

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

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain
Study Start Date : August 2005
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Impairment by pain

Secondary Outcome Measures :
  1. Pain intensity
  2. physical function and emotional state assessed by questionnaires
  3. number of serious adverse events
  4. subjective rating of improvement by therapy
  5. subjective rating of therapy effectiveness
  6. therapy satisfaction rated by patient

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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ClinicalTrials.gov Identifier: NCT00176163     History of Changes
Other Study ID Numbers: kfg107
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 2, 2010
Last Verified: September 2005

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

Additional relevant MeSH terms:
Back Pain
Fibromyalgia
Myofascial Pain Syndromes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Dronabinol
Hallucinogens
 Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists