Vaporized Cannabis and Spinal Cord Injury Pain

NCT01555983 | Completed Phase 2 Results

• 2 other identifiers: 2564121R01DA030424-01A1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Keywords

cannabis; central neuropathic pain; analgesia

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving a Reduction in Pain Intensity of 30% or More

  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.

  hourly pain assessments for 8 hours

Study Arms (3)

Vaporization of Cannabis 6.7% THC

ACTIVE COMPARATOR

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

Drug: Vaporization of Cannabis

Vaporization of Cannabis 2.9% THC

ACTIVE COMPARATOR

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

Drug: Vaporization of Cannabis

Vaporization of Cannabis Placebo THC

PLACEBO COMPARATOR

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

Drug: Vaporization of Cannabis

Interventions

Vaporization of Cannabis DRUG

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

Also known as: Medical Marijuana

Vaporization of Cannabis 2.9% THC; Vaporization of Cannabis 6.7% THC; Vaporization of Cannabis Placebo THC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 and less than 70
• Pain intensity ≥ 4/10
• 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
• Leeds Assessment of Neuropathic Symptoms and Signs score greater than or equal to 12
• Spinal cord injury of 3 or more months duration (to avoid spontaneous recovery obfuscating generalizability)

You may not qualify if:

• Known concomitant cerebral damage/cognitive impairment (TBI, Alzheimer's Disease Vascular dementia, Parkinson's disease, dementia with Lewy Bodies and Front temporal dementia
• 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
• 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)
• Active substance abuse within past year using "The Substance Abuse Module of Diagnostic Interview Schedule for DSM-IV
• Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test
• Currently on probation or parole.
• 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

Sponsors & Collaborators

• Barth Wilsey: lead
• VA Northern California Health Care System: collaborator
• University of California, San Diego: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UC Davis CTSC Clinical Research Center , Sacramento VA Medical Center

Mather, California, 95655, United States

Location

Related Publications (5)

• Wilsey B, Marcotte T, Tsodikov A, Millman J, Bentley H, Gouaux B, Fishman S. A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic pain. J Pain. 2008 Jun;9(6):506-21. doi: 10.1016/j.jpain.2007.12.010. Epub 2008 Apr 10.

  PMID: 18403272 BACKGROUND

• Abrams DI, Jay CA, Shade SB, Vizoso H, Reda H, Press S, Kelly ME, Rowbotham MC, Petersen KL. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology. 2007 Feb 13;68(7):515-21. doi: 10.1212/01.wnl.0000253187.66183.9c.

  PMID: 17296917 BACKGROUND

• Abrams DI, Vizoso HP, Shade SB, Jay C, Kelly ME, Benowitz NL. Vaporization as a smokeless cannabis delivery system: a pilot study. Clin Pharmacol Ther. 2007 Nov;82(5):572-8. doi: 10.1038/sj.clpt.6100200. Epub 2007 Apr 11.

  PMID: 17429350 BACKGROUND

• Ellis RJ, Toperoff W, Vaida F, van den Brande G, Gonzales J, Gouaux B, Bentley H, Atkinson JH. Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial. Neuropsychopharmacology. 2009 Feb;34(3):672-80. doi: 10.1038/npp.2008.120. Epub 2008 Aug 6.

  PMID: 18688212 BACKGROUND

• Wallace M, Schulteis G, Atkinson JH, Wolfson T, Lazzaretto D, Bentley H, Gouaux B, Abramson I. Dose-dependent effects of smoked cannabis on capsaicin-induced pain and hyperalgesia in healthy volunteers. Anesthesiology. 2007 Nov;107(5):785-96. doi: 10.1097/01.anes.0000286986.92475.b7.

  PMID: 18073554 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Cord Diseases; Marijuana Abuse; Agnosia

Interventions

Medical Marijuana

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Results Point of Contact

• Title: Barth Wilsey MD
• Organization: UC Davis (currently at UC San Diego)

bwilsey@ucsd.edu

916-402-2270

Study Officials

• Barth Wilsey, MD

  UC San Diego, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: March 16, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 18, 2017
• Results First Posted: January 15, 2016

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)