Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
28 participants
INTERVENTIONAL
2003-11-30
2006-02-28
Brief Summary
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Detailed Description
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In addition to studying spontaneous pain antinociception, it would be useful to evaluate the response to marijuana following evoked pain. Such evoked pain is produced by stimulation of the skin that is normally not noxious.
Because of the potential side effects of marijuana administration, one of the aims of the present study is to analyze inter-individual variability and the occurrence of dose-dependant analgesia of marijuana with an eye on defining tolerable dosing in clinical neuropathic pain syndromes.
Comparisons: Neuropathic and experimentally induced pain scores will be compared after the administration of escalating doses of low, high, and placebo marijuana cigarettes as provided by the National Institutes on Drug Abuse (NIDA).
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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1
High dose cannabis (7.5% THC by weight)
Cannabis
2
Low dose cannabis (3.5% THC by weight)
Cannabis
3
Placebo cannabis
Cannabis
Interventions
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Cannabis
Eligibility Criteria
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Inclusion Criteria
* Age greater than 18 and less than 70
* VAS greater than 3/10
* History of previous marijuana use (i.e., avoidance of marijuana naive subjects)
* Negative urine drug screening test
* Nerve Injury a.k.a. Complex Regional Pain Syndrome Type II OR
* Complex Regional Pain Syndrome Type I OR
* Neuropathic pain due to confirmed bilateral distal peripheral neuropathy associated with Diabetes I or II, focal nerve injury, postherpetic neuralgia, spinal cord injury with incomplete myelopathy, central pain following a stroke or focal brain lesion, or clinical definite multiple sclerosis of at least 3 months duration.
Exclusion Criteria
* Unstable Type 1 or 2 diabetes defined as blood glucose more than 156 mg/dl
* For diabetic subjects maintained on insulin with a stable blood glucose more than 156 mg/dl, a hemoglobin A1C level of more than 0.11 (normal range, 0.048-0.067)
* History of traumatic brain injury
* History of schizophrenia or a past or current history of a serious psychiatric disorder that is currently not well controlled with medications
* Uncontrolled medical condition - coronary artery disease, hypertension, cerebrovascular disease, asthma, TB, COPD, opportunistic infection, malignancy requiring active treatment
* Active substance abuse (alcohol or injection drugs)
* Current use of marijuana (within 30 days of randomization) as determined by urine screening
18 Years
70 Years
ALL
No
Sponsors
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Center for Medicinal Cannabis Research
OTHER
Responsible Party
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University of California, Davis
Principal Investigators
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Barth L Wilsey, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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UC Davis Medical Center
Sacramento, California, United States
Countries
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Related Links
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Center For Medicinal Cannabis Research
Other Identifiers
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C02-DA-114
Identifier Type: -
Identifier Source: org_study_id