Trial Outcomes & Findings for Effects of Vaporized Marijuana on Neuropathic Pain (NCT NCT01037088)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

44 participants

Primary outcome timeframe

baseline to six hours

Results posted on

2018-01-31

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	All Participants All participants were randomized to a 3 way cross over design and received 3.53% THC, 1.29% THC and placebo cannabis.
Overall Study STARTED	39
Overall Study Received 3.53% THC	36
Overall Study Received 1.29% THC	37
Overall Study Received Placebo	38
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants All participants were randomized to a 3 way cross over design and received 3.53% THC, 1.29% THC and placebo cannabis.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Effects of Vaporized Marijuana on Neuropathic Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=39 Participants All participants who were randomized
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	50 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to six hours

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Mild Dose Cannabis n=36 Participants 3.53% THC by weight	Low Dose Cannabis n=37 Participants 1.29% THC by weight	Placebo Cannabis n=38 Participants trace THC by weight
Participants With 30% or Greater Reduction in Pain Intensity	61 percentage of participants Interval 45.0 to 75.0	57 percentage of participants Interval 41.0 to 71.0	26 percentage of participants Interval 15.0 to 42.0

SECONDARY outcome

Timeframe: baseline to six hours

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).

Outcome measures

Outcome measures
Measure	Mild Dose Cannabis n=36 Participants 3.53% THC by weight	Low Dose Cannabis n=37 Participants 1.29% THC by weight	Placebo Cannabis n=38 Participants trace THC by weight
Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis Baseline prior to Administration of Cannabis	57.3 units on a scale Standard Deviation 24.1	54.4 units on a scale Standard Deviation 23.4	57.5 units on a scale Standard Deviation 22.8
Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis Hour 1 after Administration of Cannabis	51.8 units on a scale Standard Deviation 22.1	49.8 units on a scale Standard Deviation 25.7	56.5 units on a scale Standard Deviation 24.1
Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis Hour 2 after Administration of Cannabis	44.3 units on a scale Standard Deviation 26.8	45.8 units on a scale Standard Deviation 26.4	55.4 units on a scale Standard Deviation 25.1
Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis Hour 3 after Administration of Cannabis	39.7 units on a scale Standard Deviation 25.8	38.2 units on a scale Standard Deviation 27.1	50.7 units on a scale Standard Deviation 25.0
Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis Hour 4 after Administration of Cannabis	40.4 units on a scale Standard Deviation 26.9	39.5 units on a scale Standard Deviation 27.2	48.1 units on a scale Standard Deviation 25.6
Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis Hour 5 after Administration of Cannabis	41.7 units on a scale Standard Deviation 25.5	40.7 units on a scale Standard Deviation 27.2	51.8 units on a scale Standard Deviation 25.1

Adverse Events

Mild Dose Cannabis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Dose Cannabis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Cannabis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Barth Wilsey, MD

UCaliforniaDavis

Phone: 916-843-9082

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place