Trial Outcomes & Findings for Vaporized Cannabis and Spinal Cord Injury Pain (NCT NCT01555983)

NCT ID: NCT01555983

Last Updated: 2017-04-18

Results Overview

Number of participants achieving a reduction of pain intensity of 30% or more, a level believed to be clinically important, was estimated for each treatment dose.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 42 participants
• Primary outcome timeframe: hourly pain assessments for 8 hours
• Results posted on: 2017-04-18

Participant Flow

Participants were enrolled via recruitment from the UC Davis Medical Center Spinal Cord Injury Clinic, IRB-approved recruitment letters and newspaper advertisements.

Screening for inclusion criteria (e.g., age > 18 and ≤ 70, pain intensity ≥ 4/10 and Leeds Assessment of Neuropathic Symptoms and Signs, a pain scale based on analysis of sensory description and bedside examination of sensory dysfunction. A threshold of ≥12 on this instrument was utilized to substantiate neuropathic pain.

Participant milestones

Measure	Placebo First, Then 2.9%THC, Then 6.7% THC Placebo in am of first intervention visit, 2.9%THC in am of second intervention visit (after 3-10 day washout period) and then 6.7%THC in am of third intervention visit (after 3-10 day washout period).	Placebo First, Then 6.7%THC, Then 2.9%THC Placebo in am of first intervention visit, 6.7%THC in am of second intervention visit (after 3-10 day washout period) and then 2.9%THC in am of third intervention visit (after 3-10 day washout period).	2.9%THC First, Then Placebo, Then 6.7%THC 2.9%THC in am of first intervention visit, placebo in am of second intervention visit (after 3-10 day washout period) and then 6.7%THC am of third intervention visit (after 3-10 day washout period)	2.9%THC First, Then 6.7%THC, Then Placebo 2.9%THC in am of first intervention visit, then 6.7%THC in am of second intervention visit (after 3-10 day washout period) and then placebo in am of third intervention visit (after 3-10 day washout period).	6.7%THC First, Then Placebo, Then 2.9%THC 6.7%THC in am of first intervention visit, then placebo in am of second intervention visit (after 3-10 day washout period) and then 2.9%THC in am of third intervention visit (after 3-10 day washout period).	6.7%THC First, Then 2.9%THC, Then Placebo 6.7%THC in am of first intervention visit, then 2.9%THC in am of second intervention visit (after 3-10 day washout period) and then placebo in am of third intervention visit (after 3-10 day washout period).
Overall Study STARTED	9	7	7	7	5	7
Overall Study COMPLETED	8	7	7	7	4	6
Overall Study NOT COMPLETED	1	0	0	0	1	1

Reasons for withdrawal

Measure	Placebo First, Then 2.9%THC, Then 6.7% THC Placebo in am of first intervention visit, 2.9%THC in am of second intervention visit (after 3-10 day washout period) and then 6.7%THC in am of third intervention visit (after 3-10 day washout period).	Placebo First, Then 6.7%THC, Then 2.9%THC Placebo in am of first intervention visit, 6.7%THC in am of second intervention visit (after 3-10 day washout period) and then 2.9%THC in am of third intervention visit (after 3-10 day washout period).	2.9%THC First, Then Placebo, Then 6.7%THC 2.9%THC in am of first intervention visit, placebo in am of second intervention visit (after 3-10 day washout period) and then 6.7%THC am of third intervention visit (after 3-10 day washout period)	2.9%THC First, Then 6.7%THC, Then Placebo 2.9%THC in am of first intervention visit, then 6.7%THC in am of second intervention visit (after 3-10 day washout period) and then placebo in am of third intervention visit (after 3-10 day washout period).	6.7%THC First, Then Placebo, Then 2.9%THC 6.7%THC in am of first intervention visit, then placebo in am of second intervention visit (after 3-10 day washout period) and then 2.9%THC in am of third intervention visit (after 3-10 day washout period).	6.7%THC First, Then 2.9%THC, Then Placebo 6.7%THC in am of first intervention visit, then 2.9%THC in am of second intervention visit (after 3-10 day washout period) and then placebo in am of third intervention visit (after 3-10 day washout period).
Overall Study Withdrawal by Subject	1	0	0	0	1	1

Baseline Characteristics

Vaporized Cannabis and Spinal Cord Injury Pain

Baseline characteristics by cohort

Measure	All Study Participants n=42 Participants All participants received all interventions
Age, Continuous	46.4 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants

PRIMARY outcome

Timeframe: hourly pain assessments for 8 hours

Number of participants achieving a reduction of pain intensity of 30% or more, a level believed to be clinically important, was estimated for each treatment dose.

Outcome measures

Measure	Placebo THC n=41 Participants Session at which placebo THC was administered	2.9% THC n=38 Participants Vaporization of Cannabis 2.9% THC	6.7% THC n=41 Participants Vaporization of Cannabis 6.7% THC
Number of Participants Achieving a Reduction in Pain Intensity of 30% or More	18 participants	26 participants	35 participants

Adverse Events

Placebo THC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2.9% THC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

6.7% THC

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo THC n=41 participants at risk Vaporization of Cannabis Placebo THC	2.9% THC n=38 participants at risk Vaporization of Cannabis 2.9% THC	6.7% THC n=41 participants at risk Vaporization of Cannabis 6.7% THC
Cardiac disorders orthostatic hypotension	0.00% 0/41 • participants were followed for the 8 hour duration of clinical research center stay	0.00% 0/38 • participants were followed for the 8 hour duration of clinical research center stay	2.4% 1/41 • Number of events 1 • participants were followed for the 8 hour duration of clinical research center stay

Additional Information

Barth Wilsey MD

UC Davis (currently at UC San Diego)

Phone: 916-402-2270

Email: bwilsey@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place