Effects of Vaporized Marijuana on Neuropathic Pain - Full Text View

Sponsor:	University of California, Davis
Collaborators:	Center for Medicinal Cannabis Research VA Northern California Health Care System
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT01037088

Purpose

The specific aim of this study is to measure the pain-relieving effects of vaporized marijuana in subjects with neuropathic pain. An evaluation of pain relief with mood, cognitive impairment, and psychomotor performance will also be collected to help evaluate the utility of vaporized marijuana in a neuropathic pain population.

Condition	Intervention	Phase
Neuropathic Pain Reflex Sympathetic Dystrophy Peripheral Neuropathy Post-herpetic Neuralgia Post Stroke Pain Spinal Cord Injury Multiple Sclerosis	Drug: Cannabis	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	CCRC: The Analgesic Effect of Vaporized Cannabis on Neuropathic Pain

Resource links provided by NLM:

MedlinePlus related topics: Marijuana Multiple Sclerosis Peripheral Nerve Disorders Shingles Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

Score on a series of pain scales (heat pain threshold, VAS intensity, VAS unpleasantness, pain relief, neuropathic pain scale). [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of subjects who are unable to tolerate the high dose without significant side effects. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Changes in mood, cognitive impairment, and psychomotor performance (mood - VAS happiness, cognition - Digit Symbol Modalities Test, psychomotor performance - Grooved Pegboard Test). [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	44
Study Start Date:	December 2009
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Mild dose cannabis 3.53% THC by weight	Drug: Cannabis 3.53% THC by weight
Experimental: Low dose cannabis 1.29% THC by weight	Drug: Cannabis 1.29% THC by weight
Placebo Comparator: Placebo cannabis	Drug: Cannabis 0.00% THC by weight

Detailed Description:

The case for marijuana's medical use for pain is primarily from experimental studies with normal subjects, which have yielded conflicting results. Experimental subjects have been shown to have significant dose-dependant antinociception effect that is not reversed by opioid antagonism. In contrast to this positive antinociceptive effect, other experiments demonstrated hyperalgesic activity and probably enhancement of the perception of pain upon acute exposure in chronic users of marijuana.

In addition to studying spontaneous pain antinociception, it would be useful to evaluate the response to marijuana following evoked pain. Such evoked pain is produced by stimulation of the skin that is normally not noxious.

Because of the potential side effects of marijuana administration, one of the aims of the present study is to analyze inter-individual variability and the occurrence of dose-dependant analgesia of marijuana with an eye on defining tolerable dosing in clinical neuropathic pain syndromes.

Comparisons: Neuropathic and experimentally induced pain scores will be compared after the administration of escalating doses of low, high, and placebo marijuana cigarettes as provided by the National Institutes on Drug Abuse (NIDA).

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037088

Locations

United States, California
CTSC Clinical Research Center, Sacramento VA Medical Center
Sacramento, California, United States, 95817

Sponsors and Collaborators

University of California, Davis

Center for Medicinal Cannabis Research

VA Northern California Health Care System

Investigators

Principal Investigator:

Barth L Wilsey, MD

University of California, Davis

More Information

Additional Information:

Center for Medicinal Cannabis Research website This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2008 Apr 10.

Responsible Party:	Barth L. Wilsey, MD, Univeristy of California, Davis
ClinicalTrials.gov Identifier:	NCT01037088 History of Changes
Other Study ID Numbers:	200614658, C06-DA-119
Study First Received:	December 17, 2009
Last Updated:	August 4, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Davis:

cannabis
marijuana
neuropathy
antinociception

mood
cognition
neuropathic pain

Additional relevant MeSH terms:

Multiple Sclerosis
Neuralgia
Peripheral Nervous System Diseases
Neuralgia, Postherpetic
Reflex Sympathetic Dystrophy
Sclerosis
Spinal Cord Injuries
Stroke
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pain

Neurologic Manifestations
Neuromuscular Diseases
Signs and Symptoms
Complex Regional Pain Syndromes
Autonomic Nervous System Diseases
Pathologic Processes
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Cerebrovascular Disorders
Brain Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2012