Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
44 participants
INTERVENTIONAL
2009-12-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Mild dose cannabis
3.53% THC by weight
Mild dose cannabis
3.53% THC by weight
Low dose cannabis
1.29% THC by weight
Low dose cannabis
1.29% THC by weight
Placebo cannabis
placebo marijuana
Cannabis
0.00% THC by weight
Interventions
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Mild dose cannabis
3.53% THC by weight
Low dose cannabis
1.29% THC by weight
Cannabis
0.00% THC by weight
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Visual Analogue Scale (VAS pain intensity) greater than 3/10
* A negative urine drug screening test, i.e., no evidence of IV drug abuse
* Neuropathic pain due to reflex sympathetic dystrophy, peripheral neuropathy, post-herpetic neuralgia, post-stroke pain, multiple sclerosis or spinal cord injury
Exclusion Criteria
* Subjects with moderate-severe major depression, bipolar/mania, bipolar II/hypomania and schizophrenia or schizoaffective disorder.
* Unstable Type 1 or 2 diabetes defined as blood glucose more than 156 mg/dl
* History of traumatic brain injury
* Uncontrolled medical condition, including coronary artery disease, hypertension, cerebrovascular disease, asthma, tuberculosis (TB), chronic obstructive pulmonary disease (COPD), opportunistic infection, malignancy requiring active treatment, active substance abuse (alcohol or injection drugs).
* Current use of marijuana (e.g., within 30 days of randomization)
* Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test.
18 Years
70 Years
ALL
No
Sponsors
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Center for Medicinal Cannabis Research
OTHER
VA Northern California Health Care System
FED
University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Barth L Wilsey, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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CTSC Clinical Research Center, Sacramento VA Medical Center
Sacramento, California, United States
Countries
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References
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Wilsey B, Marcotte T, Tsodikov A, Millman J, Bentley H, Gouaux B, Fishman S. A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic pain. J Pain. 2008 Jun;9(6):506-21. doi: 10.1016/j.jpain.2007.12.010. Epub 2008 Apr 10.
Related Links
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Center for Medicinal Cannabis Research website
Other Identifiers
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C06-DA-119
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
200614658
Identifier Type: -
Identifier Source: org_study_id
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