Effects of Vaporized Marijuana on Neuropathic Pain

NCT ID: NCT01037088

Last Updated: 2018-01-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-11-30

Brief Summary

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This study theorized that a low dose of vaporized cannabis could alleviate nerve injury pain.

Detailed Description

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We conducted a double-blind, placebo-controlled, crossover study evaluating the analgesic efficacy of vaporized cannabis in subjects, the majority of whom were experiencing neuropathic pain despite traditional treatment. Thirty-nine patients with central and peripheral neuropathic pain underwent a standardized procedure for inhaling medium-dose (3.53%), low-dose (1.29%), or placebo cannabis with the primary outcome being visual analog scale pain intensity. Psychoactive side effects and neuropsychological performance were also evaluated.

Conditions

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Neuropathic Pain Reflex Sympathetic Dystrophy Peripheral Neuropathy Post-herpetic Neuralgia Spinal Cord Injury Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Mild dose cannabis

3.53% THC by weight

Group Type EXPERIMENTAL

Mild dose cannabis

Intervention Type DRUG

3.53% THC by weight

Low dose cannabis

1.29% THC by weight

Group Type EXPERIMENTAL

Low dose cannabis

Intervention Type DRUG

1.29% THC by weight

Placebo cannabis

placebo marijuana

Group Type PLACEBO_COMPARATOR

Cannabis

Intervention Type DRUG

0.00% THC by weight

Interventions

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Mild dose cannabis

3.53% THC by weight

Intervention Type DRUG

Low dose cannabis

1.29% THC by weight

Intervention Type DRUG

Cannabis

0.00% THC by weight

Intervention Type DRUG

Other Intervention Names

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marijuana marijuana placebo marijuana

Eligibility Criteria

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Inclusion Criteria

* Age greater than 18 and less than 70
* Visual Analogue Scale (VAS pain intensity) greater than 3/10
* A negative urine drug screening test, i.e., no evidence of IV drug abuse
* Neuropathic pain due to reflex sympathetic dystrophy, peripheral neuropathy, post-herpetic neuralgia, post-stroke pain, multiple sclerosis or spinal cord injury

Exclusion Criteria

* Presence of another painful condition of greater severity than the neuropathic pain condition which is being studied.
* Subjects with moderate-severe major depression, bipolar/mania, bipolar II/hypomania and schizophrenia or schizoaffective disorder.
* Unstable Type 1 or 2 diabetes defined as blood glucose more than 156 mg/dl
* History of traumatic brain injury
* Uncontrolled medical condition, including coronary artery disease, hypertension, cerebrovascular disease, asthma, tuberculosis (TB), chronic obstructive pulmonary disease (COPD), opportunistic infection, malignancy requiring active treatment, active substance abuse (alcohol or injection drugs).
* Current use of marijuana (e.g., within 30 days of randomization)
* Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Center for Medicinal Cannabis Research

OTHER

Sponsor Role collaborator

VA Northern California Health Care System

FED

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barth L Wilsey, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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CTSC Clinical Research Center, Sacramento VA Medical Center

Sacramento, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18403272 (View on PubMed)

Related Links

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http://www.cmcr.ucsd.edu/

Center for Medicinal Cannabis Research website

Other Identifiers

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C06-DA-119

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

200614658

Identifier Type: -

Identifier Source: org_study_id

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