Trial record 8 of 8 for:
Barth Syndrome
Effects of Vaporized Marijuana on Neuropathic Pain
This study has been completed.
Sponsor:
University of California, Davis
Collaborators:
Center for Medicinal Cannabis Research
VA Northern California Health Care System
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01037088
First received: December 17, 2009
Last updated: April 5, 2013
Last verified: April 2013
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Purpose
This study theorized that a low dose of vaporized cannabis could alleviate nerve injury pain.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuropathic Pain Reflex Sympathetic Dystrophy Peripheral Neuropathy Post-herpetic Neuralgia Spinal Cord Injury Multiple Sclerosis |
Drug: Cannabis |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | CCRC: The Analgesic Effect of Vaporized Cannabis on Neuropathic Pain |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Marijuana
Multiple Sclerosis
Peripheral Nerve Disorders
Shingles
Spinal Cord Injuries
U.S. FDA Resources
Further study details as provided by University of California, Davis:
Primary Outcome Measures:
- Participants With 30% or Greater Reduction in Pain Intensity [ Time Frame: baseline to six hours ] [ Designated as safety issue: No ]The primary outcome variable, VAS Pain Intensity, was assessed by asking participants to indicate the intensity of their current pain on a 100-mm visual analog scale (VAS) between 0 (no pain) and 100 (worst possible pain).An assessment was performed before the administration of vaporized cannabis or placebo and hourly thereafter for six hours.
| Enrollment: | 44 |
| Study Start Date: | December 2009 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Mild dose cannabis
3.53% THC by weight
|
Drug: Cannabis
3.53% THC by weight
Other Name: marijuana
|
|
Experimental: Low dose cannabis
1.29% THC by weight
|
Drug: Cannabis
1.29% THC by weight
Other Name: marijuana
|
|
Placebo Comparator: Placebo cannabis
placebo marijuana
|
Drug: Cannabis
0.00% THC by weight
Other Name: placebo marijuana
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age greater than 18 and less than 70
- 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:
- Presence of another painful condition of greater severity than the neuropathic pain condition which is being studied.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037088
Locations
| United States, California | |
| CTSC Clinical Research Center, Sacramento VA Medical Center | |
| Sacramento, California, United States, 95817 | |
Sponsors and Collaborators
University of California, Davis
Center for Medicinal Cannabis Research
VA Northern California Health Care System
Investigators
| Principal Investigator: | Barth L Wilsey, MD | University of California, Davis |
More Information
Additional Information:
Publications:
| Responsible Party: | University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT01037088 History of Changes |
| Other Study ID Numbers: | 200614658, C06-DA-119 |
| Study First Received: | December 17, 2009 |
| Results First Received: | December 6, 2012 |
| Last Updated: | April 5, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of California, Davis:
|
cannabis marijuana neuropathy antinociception |
mood cognition neuropathic pain |
Additional relevant MeSH terms:
|
Complex Regional Pain Syndromes Multiple Sclerosis Neuralgia Peripheral Nervous System Diseases Neuralgia, Postherpetic Reflex Sympathetic Dystrophy Sclerosis Spinal Cord Injuries Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases |
Autoimmune Diseases Immune System Diseases Pain Neurologic Manifestations Neuromuscular Diseases Signs and Symptoms Autonomic Nervous System Diseases Pathologic Processes Spinal Cord Diseases Central Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013