A Phase 1/2 interventional study of Mild dose cannabis and Low dose cannabis in Neuropathic Pain, Reflex Sympathetic Dystrophy and Peripheral Neuropathy, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-01-31.
Sponsored by University of California, Davis · Phase 1/2, Interventional, and Treatment
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 44 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
3.53% THC by weight
Drug: Mild dose cannabis
1.29% THC by weight
Drug: Low dose cannabis
placebo marijuana
Drug: Cannabis
3.53% THC by weight
Also known as: marijuana
1.29% THC by weight
Also known as: marijuana
0.00% THC by weight
Also known as: placebo marijuana
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.
Time frame: baseline to six hours
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).
Time frame: baseline to six hours
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.
| Milestone | All Participants |
|---|---|
| Started | 39 |
| Received 3.53% thc | 36 |
| Received 1.29% thc | 37 |
| Received placebo | 38 |
| Completed | 36 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 3 |
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.
| percentage of participants | Mild Dose Cannabis | Low Dose Cannabis | Placebo Cannabis |
|---|---|---|---|
| Participants With 30% or Greater Reduction in Pain Intensity | 61 (45 to 75) | 57 (41 to 71) | 26 (15 to 42) |
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).
| units on a scale | Mild Dose Cannabis | Low Dose Cannabis | Placebo Cannabis |
|---|---|---|---|
| Baseline prior to Administration of Cannabis | 57.3 ± 24.1 | 54.4 ± 23.4 | 57.5 ± 22.8 |
| Hour 1 after Administration of Cannabis | 51.8 ± 22.1 | 49.8 ± 25.7 | 56.5 ± 24.1 |
| Hour 2 after Administration of Cannabis | 44.3 ± 26.8 | 45.8 ± 26.4 | 55.4 ± 25.1 |
| Hour 3 after Administration of Cannabis | 39.7 ± 25.8 | 38.2 ± 27.1 | 50.7 ± 25.0 |
| Hour 4 after Administration of Cannabis | 40.4 ± 26.9 | 39.5 ± 27.2 | 48.1 ± 25.6 |
| Hour 5 after Administration of Cannabis | 41.7 ± 25.5 | 40.7 ± 27.2 | 51.8 ± 25.1 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mild Dose Cannabis | — | 0/36 (0%) | 0/36 (0%) |
| Low Dose Cannabis | — | 0/37 (0%) | 0/37 (0%) |
| Placebo Cannabis | — | 0/38 (0%) | 0/38 (0%) |
| Age, Categorical(Participants) | All Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 39 |
| >=65 years | 0 |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 50 ± 11 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 11 |
| Male | 28 |
| Region of Enrollment(participants) | All Participants |
|---|---|
| United States | 39 |
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, Davis