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:

MedlinePlus related topics: Back Pain Fibromyalgia

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 (Adult, Senior)
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


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 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

ClinicalTrials.gov processed this record on September 30, 2016

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