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

CompletedPhase 2NCT00176163
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain
Interventions
  • Behavioral: Operant behavioral treatment
  • Drug: THC
Sponsor
Heidelberg University
Collaborators
Central Institute of Mental Health, Mannheim; University of Mannheim; Academic City Hospital, Germany; BG Trauma Center Ludwigshafen
Start date
2005-08
Sex
All
Age range
from 18 Years to 70 Years
Results posted
No results posted in this snapshot
Total sites listed
0

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00176163