Vaporized Cannabis and Spinal Cord Injury Pain

Barth Wilsey

Status and phase: Completed; Phase 3; Phase 2

Conditions: Spinal Cord Injuries; Spinal Cord Diseases

Treatments: Drug: Vaporization of Cannabis

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT01555983

1R01DA030424-01A1 (U.S. NIH Grant/Contract)

256412

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age greater than 18 and less than 70
2. Pain intensity ≥ 4/10
3. Neuropathic pain defined as chronic pain in an area of sensory abnormality corresponding to the spinal cord or nerve root lesion, and the pain should have no primary relation to movement, inflammation or other local tissue damage
4. Leeds Assessment of Neuropathic Symptoms and Signs score greater than or equal to 12
5. Spinal cord injury of 3 or more months duration (to avoid spontaneous recovery obfuscating generalizability)

Exclusion criteria

1. Known concomitant cerebral damage/cognitive impairment (TBI, Alzheimer's Disease Vascular dementia, Parkinson's disease, dementia with Lewy Bodies and Front temporal dementia
2. Clinically significant or unstable medical condition (i.e., cardiac, respiratory, hepatic or renal disease) that, in the opinion of the investigator, would compromise participation in the study
3. Neurologic disorders unrelated to spinal cord injury that may confound the assessment of the central neuropathic pain due to spinal cord injury (hereditary neuropathies; diabetic peripheral neuropathy; traumatic neuropathy; and immune-mediated neuropathies)
4. Active substance abuse within past year using "The Substance Abuse Module of Diagnostic Interview Schedule for DSM-IV
5. Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test
6. Currently on probation or parole.
7. Hx of Schizophrenia, Bipolar Depression with Mania, current suicidal ideation or past history of suicide attempt 8. Severe depression (Patient Health Questionnaire-9 ≥ 15) 9. Current suicidal ideation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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42 participants in 3 patient groups, including a placebo group

Vaporization of Cannabis 6.7% THC

Active Comparator group

Description:

Inhaling of standardized measured puffs of Vaporized High Dose 6.7% THC. Monitored for 8 hours measuring psychoactive and analgesic effects.

Treatment:

Drug: Vaporization of Cannabis

Vaporization of Cannabis 2.9% THC

Active Comparator group

Description:

Inhaling standardized measured puffs of Vaporized Low Dose 2.9% THC. Monitored for 8 hours measuring psychoactive and analgesic effects.

Treatment:

Drug: Vaporization of Cannabis

Vaporization of Cannabis Placebo THC

Placebo Comparator group

Description:

Inhaling standardized measured puffs of Placebo THC. Monitored for 8 hours measuring psychoactive and analgesic effects.

Treatment:

Drug: Vaporization of Cannabis