FibromyalgiaPhase 2NCT00176163
Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain
A Phase 2 study testing Operant behavioral treatment; Drug: THC in people with Fibromyalgia and Back Pain, run by Heidelberg University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia, Back Pain
- What is being tested?
- Operant behavioral treatment; Drug: THC
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to May 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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
- Being tested
- Operant behavioral treatment; Drug: THC
- Keywords
- Fibromyalgia, Back pain, Behavior Therapy, Operant learning, Tetrahydrocannabinol
- Medical subject headings
- Fibromyalgia, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operant behavioral treatment; Drug: THCBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Impairment by pain
Secondary outcomes (6)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2005
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Central Institute of Mental Health, Mannheim, University of Mannheim, Academic City Hospital, Germany, BG Trauma Center Ludwigshafen
- Investigators
- Justus Benrath, MD, PhD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176163
- Sponsor's protocol ID
- kfg107
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 2 Feb 2010
- Results posted
- No
Publications
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.
PubMed 29870396
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain
- ClinicalTrials.gov ID
- NCT00176163
- Acronym / sponsor ID
- kfg107
- Conditions
- Fibromyalgia, Back Pain
- Keywords
- Fibromyalgia, Back pain, Behavior Therapy, Operant learning, Tetrahydrocannabinol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Central Institute of Mental Health, Mannheim, University of Mannheim, Academic City Hospital, Germany, BG Trauma Center Ludwigshafen
- Study start
- Aug 2005
- Study completion
- May 2009
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Operant behavioral treatment; Drug: THC | Behavioural | – |
Primary outcome
Impairment by pain
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
- Derived from this study: PubMed 29870396Finnern 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justus Benrath, MD, PhD principal investigator
Heidelberg University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Operant behavioral treatment; Drug: THC in people with Fibromyalgia and Back Pain, run by Heidelberg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impairment by pain. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00176163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2010.