Conditions: Spinal Cord Injuries Spinal Cord Diseases
Keywords: cannabis central neuropathic pain analgesia
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 42
Healthy volunteers: no

Brief summary:
This study will demonstrate that vaporized marijuana results in antinociception when compared to placebo in subjects with spinal cord injury. To further evaluate potential benefits and side effects, the effect of different strengths of cannabis on mood, cognition, and psychomotor performance will also be measured.

Detailed description:
This study will demonstrate that vaporized cannabis can produce antinociceptive effects compared to placebo in human subjects with spinal cord injury (SCI). A within-subject crossover study of the effects of cannabis versus placebo on spontaneous and evoked pain will be performed. A synopsis of antinociception with mood, cognitive impairment, psychomotor performance, and side effects will be obtained to help evaluate the utility of vaporized marijuana in SCI neuropathic pain.

This study will compare the analgesic and side effect profile of low (3.5%) to high dose (7.0%) delta 9-tetrahydrocannabinol in subjects with spinal cord injury pain. It is hypothesized that a low dose will produce a lesser degree of neuropsychological impairment while maintaining a similar degree of pain relief to the higher dose. The use of two different strengths will help determine tolerable dosing for the treatment of SCI neuropathic pain.

Arms:
arm 1: Inhaling of standardized measured puffs of Vaporized High Dose 6.7% THC. Monitored for 8 hours measuring psychoactive and analgesic effects. arm 2: Inhaling standardized measured puffs of Vaporized Low Dose 2.9% THC. Monitored for 8 hours measuring psychoactive and analgesic effects. arm 3: Inhaling standardized measured puffs of Placebo THC. Monitored for 8 hours measuring psychoactive and analgesic effects.

Interventions: intervention 1: Vaporization of Cannabis
Intervention descriptions: intervention 1: Randomized, Controlled Crossover Trial of Vaporized Cannabis using different strengths of THC in patients with Central Neuropathic Pain Active Comparator: Vaporized High Dose 6.7% THC Active Comparator: Vaporized High Dose 2.9% THC Placebo Comparator: Vaporized Placebo THC

Protocol document: