Complex Regional Pain SyndromesPhase 2NCT00377468
Effect of Delta-9-Tetrahydrocannabinol on the Prevention of Chronic Pain in Patients With Acute CRPS (ETIC-Study)
A Phase 2 study testing Delta9-Tetrahydrocannabinol in people with Complex Regional Pain Syndromes and CRPS, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether application of low dose Delta9-Tetrahydrocannabinol can prevent the development of chronic pain in patients with acute CRPS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Regional Pain Syndromes, CRPS
- What is being tested?
- Delta9-Tetrahydrocannabinol
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2006to Dec 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical diagnosis of acute CRPS (time from inciting event less than 16 weeks) of the upper extremity
- No risk of dependency in a psychological assessment
Who cannot join
- History of alcohol or drug abuse
- Cardiac arrhythmias
- Acute or chronic renal failure
- ASA physical status classification III or higher
- Psychiatric disorders
- Pregnancy and breast feeding
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, Universitiy of Munich
Munich, 81377
About this study
Official title: Low Dose Administration of Delta9-Tetrahydrocannabinol for the Prevention of Hyperalgesia and Chronic Pain in Patients With Acute Complex Regional Pain Syndrome (CRPS) of the Upper Limb
The purpose of this study is to determine whether application of low dose Delta9-Tetrahydrocannabinol can prevent the development of chronic pain in patients with acute CRPS.
Read the detailed description
Recent animal data suggest that the endocannabinoid system is a promising target in the prevention of chronic pain. It has been shown that the endocannabinoid system modifies excitatory and inhibitory currents in structures involved in the development of chronic pain such as the amygdala.
CRPS is a neuropathic pain condition, which is known to become chronic in a significant percentage. The study compares the effect of low dose Delta9-Tetrahydrocannabinol (90 days) and placebo in acute CRPS. All patients will receive a standard treatment consisting of drug therapy and physiotherapy.
- Conditions
- Complex Regional Pain Syndromes, CRPS
- Being tested
- Delta9-Tetrahydrocannabinol
- Keywords
- THC, CRPS, Pain, Complex Regional Pain Syndrome, Neuropathic Pain, Chronic, Prevention
- Medical subject headings
- Complex Regional Pain Syndromes, Pain, Neuralgia, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delta9-TetrahydrocannabinolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chronic pain at one year assessed with Visual Analogue Scale (VAS)
Secondary outcomes (4)
Changes in somatosensory phenotype at one year assessed with Quantitative Sensory Testing (QST)
Motor function of the affected extremity at one year assessed with a biometric evaluation
Changes in Health Related Quality of Life at one year assessed with SF-36
Changes in plasma endocannabinoid levels at 30, 60, 90 days and at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2006 (estimated)
- Study startSep 2006
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Complex Regional Pain SyndromesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, German Research Network on Neuropathic Pain
- Investigators
- Shahnaz C Azad, MD;PhD, Principal investigator, Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377468
- Sponsor's protocol ID
- 2310106
- Other IDs
- Eudra-CT: 2006-000439-85
- Status last verified
- Jun 2008
- First submitted
- 14 Sep 2006
- Last updated
- 30 Jun 2008
- Results posted
- No
Publications
Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11.
PubMed 16697110Azad SC, Monory K, Marsicano G, Cravatt BF, Lutz B, Zieglgansberger W, Rammes G. Circuitry for associative plasticity in the amygdala involves endocannabinoid signaling. J Neurosci. 2004 Nov 3;24(44):9953-61. doi: 10.1523/JNEUROSCI.2134-04.2004.
PubMed 15525780Azad SC, Eder M, Marsicano G, Lutz B, Zieglgansberger W, Rammes G. Activation of the cannabinoid receptor type 1 decreases glutamatergic and GABAergic synaptic transmission in the lateral amygdala of the mouse. Learn Mem. 2003 Mar-Apr;10(2):116-28. doi: 10.1101/lm.53303.
PubMed 12663750
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Administration of Delta9-Tetrahydrocannabinol for the Prevention of Hyperalgesia and Chronic Pain in Patients With Acute Complex Regional Pain Syndrome (CRPS) of the Upper Limb
- ClinicalTrials.gov ID
- NCT00377468
- Acronym / sponsor ID
- 2310106
- Conditions
- Complex Regional Pain Syndromes, CRPS
- Keywords
- THC, CRPS, Pain, Complex Regional Pain Syndrome, Neuropathic Pain, Chronic, Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, German Research Network on Neuropathic Pain
- Study start
- Sep 2006
- Study completion
- Dec 2008 (estimated)
- First posted
- 18 Sep 2006 (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.
The purpose of this study is to determine whether application of low dose Delta9-Tetrahydrocannabinol can prevent the development of chronic pain in patients with acute CRPS.
Detailed description
Recent animal data suggest that the endocannabinoid system is a promising target in the prevention of chronic pain. It has been shown that the endocannabinoid system modifies excitatory and inhibitory currents in structures involved in the development of chronic pain such as the amygdala.
CRPS is a neuropathic pain condition, which is known to become chronic in a significant percentage. The study compares the effect of low dose Delta9-Tetrahydrocannabinol (90 days) and placebo in acute CRPS. All patients will receive a standard treatment consisting of drug therapy and physiotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with clinical diagnosis of acute CRPS (time from inciting event less than 16 weeks) of the upper extremity
- No risk of dependency in a psychological assessment
Key exclusion criteria (6 listed)
- History of alcohol or drug abuse
- Cardiac arrhythmias
- Acute or chronic renal failure
- ASA physical status classification III or higher
- Psychiatric disorders
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 |
|---|---|---|
| Delta9-Tetrahydrocannabinol | Drug | – |
Primary outcome
Incidence of chronic pain at one year assessed with Visual Analogue Scale (VAS)
4 secondary outcomes
Changes in somatosensory phenotype at one year assessed with Quantitative Sensory Testing (QST)
Motor function of the affected extremity at one year assessed with a biometric evaluation
Changes in Health Related Quality of Life at one year assessed with SF-36
Changes in plasma endocannabinoid levels at 30, 60, 90 days and at one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2008.
- Background: PubMed 16697110Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11.
- Background: PubMed 15525780Azad SC, Monory K, Marsicano G, Cravatt BF, Lutz B, Zieglgansberger W, Rammes G. Circuitry for associative plasticity in the amygdala involves endocannabinoid signaling. J Neurosci. 2004 Nov 3;24(44):9953-61. doi: 10.1523/JNEUROSCI.2134-04.2004.
- Background: PubMed 12663750Azad SC, Eder M, Marsicano G, Lutz B, Zieglgansberger W, Rammes G. Activation of the cannabinoid receptor type 1 decreases glutamatergic and GABAergic synaptic transmission in the lateral amygdala of the mouse. Learn Mem. 2003 Mar-Apr;10(2):116-28. doi: 10.1101/lm.53303.
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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.
Shahnaz C Azad, MD;PhD principal investigator
Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Delta9-Tetrahydrocannabinol in people with Complex Regional Pain Syndromes and CRPS, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meike Lauchart, MD (+49897095 ext. 4464, Meike.Lauchart@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of chronic pain at one year assessed with Visual Analogue Scale (VAS). 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 NCT00377468, which also lists 3 linked publications.
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 30 Jun 2008.