Neuropathic Pain
Study register · detail RCT (cross-over, human laboratory) · Neuropathic Pain · 2016

An Exploratory Human Laboratory Experiment Evaluating Vaporized Cannabis in the Treatment

Clear benefit GRADE Moderate 99 citations
Samplen = 42 Pat.
Duration8-hour human laboratory…
ControlPlacebo vaporizer
EndpointNRS
Blindingdoppelblind
DesignRCT (cross-over, human laboratory)
Cannabinoidthc
Routeinhalativ
Key finding

Vaporized cannabis showed significant analgesic effect for neuropathic pain after spinal cord injury, independent of psychoactive side effects.

Summary

n=42 neuropathic pain in spinal cord injury/disease, vaporized cannabis 2,9%/6,7% THC vs. placebo in 8-hour experiments; significant analgesic response in mixed-effects model (p<0,0004), pain reduction remained significant even after adjustment for psychoactive effects. No significant difference between the two active doses, lower dose offers better risk-benefit ratio.

P
PopulationAdults with neuropathic pain due to spinal cord injury or disease, n=42, predominantly treatment-refractory
I
InterventionVaporized cannabis 2,9% or 6,7% THC, 4 puffs initially + 4–8 puffs after 3 hours (flexible)
C
ControlPlacebo vaporizer (0% THC)
O
OutcomeSignificant pain reduction for both active doses vs. placebo (all p<0,0004), also after controlling for psychoactive side effects; no significant difference between the two active doses
Confidence in the evidence
Moderate

The third of four GRADE levels, the effect estimate is probably reliable.

Downgraded for
Imprecision
Quality profile
Sample size
Blinding Double-blind
Effect size Clear benefit
Citations / year
Authors
Wilsey B, Marcotte TD, Deutsch R, Zhao H, Prasad H, Phan A
DOI 10.1016/j.jpain.2016.05.010
Design: RCT (cross-over, human laboratory)
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Abstract
Using 8-hour human laboratory experiments, we evaluated the analgesic efficacy of vaporized cannabis in patients with neuropathic pain related to injury or disease of the spinal cord, most of whom were experiencing pain despite traditional treatment. After obtaining baseline data, 42 participants underwent a standardized procedure for inhaling 4 puffs of vaporized cannabis containing either placebo, 2.9%, or 6.7% delta 9-THC on 3 separate occasions. A second dosing occurred 3 hours later; participants chose to inhale 4 to 8 puffs. This flexible dosing was used to attempt to reduce the placebo effect. Using an 11-point numerical pain intensity rating scale as the primary outcome, a mixed effects linear regression model showed a significant analgesic response for vaporized cannabis. When subjective and psychoactive side effects (eg, good drug effect, feeling high, etc) were added as covariates to the model, the reduction in pain intensity remained significant above and beyond any effect of these measures (all P < .0004). Psychoactive and subjective effects were dose-dependent. Measurement of neuropsychological performance proved challenging because of various disabilities in the population studied. Because the 2 active doses did not significantly differ from each other in terms of analgesic potency, the lower dose appears to offer the best risk-benefit ratio in patients with neuropathic pain associated with injury or disease of the spinal cord. PERSPECTIVE: A crossover, randomized, placebo-controlled human laboratory experiment involving administration of vaporized cannabis was performed in patients with neuropathic pain related to spinal cord injury and disease. This study supports consideration of future research that would include longer duration studies over weeks to months to evaluate the efficacy of medicinal cannabis in patients with central neuropathic pain.

The impediment to action advances action. — Marcus Aurelius