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Vaporized Cannabis and Spinal Cord Injury Pain

Primary Purpose

Spinal Cord Injuries, Spinal Cord Diseases

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Vaporization of Cannabis

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring cannabis, central neuropathic pain, analgesia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

UC Davis CTSC Clinical Research Center , Sacramento VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vaporization of Cannabis 6.7% THC

Vaporization of Cannabis 2.9% THC

Vaporization of Cannabis Placebo THC

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01555983

First Posted

February 9, 2012

Last Updated

March 20, 2017

Sponsor

Barth Wilsey

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01555983

Brief Title

Vaporized Cannabis and Spinal Cord Injury Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Barth Wilsey

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries, Spinal Cord Diseases

Keywords

cannabis, central neuropathic pain, analgesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vaporization of Cannabis 6.7% THC

Arm Type

Active Comparator

Arm Description

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

Arm Title

Vaporization of Cannabis 2.9% THC

Arm Type

Active Comparator

Arm Description

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

Arm Title

Vaporization of Cannabis Placebo THC

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Vaporization of Cannabis

Other Intervention Name(s)

Medical Marijuana

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

hourly pain assessments for 8 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barth Wilsey, MD

Organizational Affiliation

UC San Diego, Department of Psychiatry

Official's Role

Principal Investigator

Facility Information:

Facility Name

UC Davis CTSC Clinical Research Center , Sacramento VA Medical Center

City

Mather

State/Province

California

ZIP/Postal Code

95655

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

email Barth Wilsey at bwilsey@ucsd.edu

Citations:

PubMed Identifier

18403272

Citation

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.

Results Reference

background

PubMed Identifier

17296917

Citation

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.

Results Reference

background

PubMed Identifier

17429350

Citation

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.

Results Reference

background

PubMed Identifier

18688212

Citation

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.

Results Reference

background

PubMed Identifier

18073554

Citation

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.

Results Reference

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Vaporized Cannabis and Spinal Cord Injury Pain

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