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| ID | Type | Description | Link |
|---|---|---|---|
| C06-DA-119 | Other Grant/Funding Number | Center for Medicinal Cannabis Research |
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| Name | Class |
|---|---|
| Center for Medicinal Cannabis Research | OTHER |
| VA Northern California Health Care System | FED |
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This study theorized that a low dose of vaporized cannabis could alleviate nerve injury pain.
We conducted a double-blind, placebo-controlled, crossover study evaluating the analgesic efficacy of vaporized cannabis in subjects, the majority of whom were experiencing neuropathic pain despite traditional treatment. Thirty-nine patients with central and peripheral neuropathic pain underwent a standardized procedure for inhaling medium-dose (3.53%), low-dose (1.29%), or placebo cannabis with the primary outcome being visual analog scale pain intensity. Psychoactive side effects and neuropsychological performance were also evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild dose cannabis | Experimental | 3.53% THC by weight |
|
| Low dose cannabis | Experimental | 1.29% THC by weight |
|
| Placebo cannabis | Placebo Comparator | placebo marijuana |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mild dose cannabis | Drug | 3.53% THC by weight |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With 30% or Greater Reduction in Pain Intensity | 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. | baseline to six hours |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis | The pain intensity scores for all of the time points (i.e., baseline prior to administration and up to 5 hours following administration of cannabis). 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barth L Wilsey, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CTSC Clinical Research Center, Sacramento VA Medical Center | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18403272 | Background | 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. |
| Label | URL |
|---|---|
| Center for Medicinal Cannabis Research website | View source |
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Twenty subjects did not receive study medication: 9 withdrew for various reasons and 11 were disqualified following a medical evaluation with subsequent disclosure of exclusionary criteria on a physical exam or laboratory finding.
Recruitment took place at the UCDMC and VA Northern California Pain clinics,UCDMC Spinal Cord Injury Clinic, and newspaper advertisements. Between December 2009 and March 2011, 59 patients were consented to enroll in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All participants were randomized to a 3 way cross over design and received 3.53% THC, 1.29% THC and placebo cannabis. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants who were randomized |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants With 30% or Greater Reduction in Pain Intensity | 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. | This was a cross over study. Ten of the 38 subjects who were exposed to placebo had a 30% reduction in pain intensity as compared to 21 of the 37 exposed to the low dose and 22 of the 36 receiving the medium dose of cannabis. | Posted | Number | 95% Confidence Interval | percentage of participants | baseline to six hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mild Dose Cannabis | 3.53% 9-delta tetrahydrocannabinol by weight |
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Inclusion of patients with complex regional pain syndrome type I. In the past, there was no doubt that this disorder should be classified as classical neuropathic pain condition; Unmasking of blinding secondary to the psychoactive effects of cannabis
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barth Wilsey, MD | UCaliforniaDavis | 916-843-9082 | blwilsey@ucdavis.edu |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D012019 | Reflex Sympathetic Dystrophy |
| D010523 | Peripheral Nervous System Diseases |
| D051474 | Neuralgia, Postherpetic |
| D013119 | Spinal Cord Injuries |
| D009103 | Multiple Sclerosis |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
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| Low dose cannabis | Drug | 1.29% THC by weight |
|
|
| Cannabis | Drug | 0.00% THC by weight |
|
|
| baseline to six hours |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Low Dose Cannabis |
1.29% THC by weight |
| OG002 | Placebo Cannabis | trace THC by weight |
|
|
| Secondary | Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis | The pain intensity scores for all of the time points (i.e., baseline prior to administration and up to 5 hours following administration of cannabis). 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). | Posted | Mean | Standard Deviation | units on a scale | baseline to six hours |
|
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Low Dose Cannabis | 1.29% 9-delta tetrahydrocannabinol by weight | 0 | 37 | 0 | 37 |
| EG002 | Placebo Cannabis | 0% 9-delta tetrahydrocannabinol by weight | 0 | 38 | 0 | 38 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020918 | Complex Regional Pain Syndromes |
| D001342 | Autonomic Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
|
| Hour 2 after Administration of Cannabis |
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| Hour 3 after Administration of Cannabis |
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| Hour 4 after Administration of Cannabis |
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| Hour 5 after Administration of Cannabis |
|
| Mixed Models Analysis |
| =.0002 |
| Superiority |
| Hour 3 after Administration of Cannabis (after the second inhalation of cannabis) | Mixed Models Analysis | <.0001 | Superiority |
| Hour 4 after Administration of Cannabis | Mixed Models Analysis | =.0004 | Superiority |
| Hour 5 after Administration of Cannabis | Mixed Models Analysis | =.0018 | Superiority |