Vaporized Cannabis and Spinal Cord Injury Pain

March 20, 2017 updated by: Barth Wilsey

The Effect of Vaporized Cannabis on Neuropathic Pain in Spinal Cord Injury

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mather, California, United States, 95655
        • UC Davis CTSC Clinical Research Center , Sacramento VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Vaporization of Cannabis 6.7% THC
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
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
Other Names:
  • Medical Marijuana
ACTIVE_COMPARATOR: Vaporization of Cannabis 2.9% THC
Inhaling standardized measured puffs of Vaporized Low Dose 2.9% THC. Monitored for 8 hours measuring psychoactive and analgesic effects.
Drug: Vaporization of Cannabis
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
Other Names:
  • Medical Marijuana
PLACEBO_COMPARATOR: Vaporization of Cannabis Placebo THC
Inhaling standardized measured puffs of Placebo THC. Monitored for 8 hours measuring psychoactive and analgesic effects.
Drug: Vaporization of Cannabis
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
Other Names:
  • Medical Marijuana

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Achieving a Reduction in Pain Intensity of 30% or More
Time Frame: 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.
hourly pain assessments for 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barth Wilsey

Collaborators

National Institute on Drug Abuse (NIDA)
University of California, San Diego
VA Northern California Health Care System

Investigators

  • Principal Investigator: Barth Wilsey, MD, UC San Diego, Department of Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

February 9, 2012

First Submitted That Met QC Criteria

March 14, 2012

First Posted (ESTIMATE)

March 16, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 256412
  • 1R01DA030424-01A1 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

email Barth Wilsey at bwilsey@ucsd.edu

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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