Effects of Vaporized Marijuana on Neuropathic Pain

NCT01037088 | Completed Phase 1 Results

• 2 other identifiers: 200614658C06-DA-119
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

cannabis; marijuana; neuropathy; antinociception; mood; cognition; neuropathic pain

Outcome Measures

Primary Outcomes (1)

• Participants With 30% or Greater Reduction in Pain Intensity

  The primary outcome variable, VAS Pain Intensity, was assessed by asking participants to indicate the intensity of their current pain on a 100-mm visual analog scale (VAS) between 0 (no pain) and 100 (worst possible pain).An assessment was performed before the administration of vaporized cannabis or placebo and hourly thereafter for six hours.

  baseline to six hours

Secondary Outcomes (1)

• Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis

  baseline to six hours

Study Arms (3)

Mild dose cannabis

EXPERIMENTAL

3.53% THC by weight

Drug: Mild dose cannabis

Low dose cannabis

EXPERIMENTAL

1.29% THC by weight

Drug: Low dose cannabis

Placebo cannabis

PLACEBO COMPARATOR

placebo marijuana

Drug: Cannabis

Interventions

Mild dose cannabis DRUG

3.53% THC by weight

Also known as: marijuana

Mild dose cannabis

Low dose cannabis DRUG

1.29% THC by weight

Also known as: marijuana

Low dose cannabis

Cannabis DRUG

0.00% THC by weight

Also known as: placebo marijuana

Placebo cannabis

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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead
• Center for Medicinal Cannabis Research: collaborator
• VA Northern California Health Care System: collaborator

Study Sites (1)

CTSC Clinical Research Center, Sacramento VA Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

• 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

Related Links

• Center for Medicinal Cannabis Research website

MeSH Terms

Conditions

Neuralgia; Reflex Sympathetic Dystrophy; Peripheral Nervous System Diseases; Neuralgia, Postherpetic; Spinal Cord Injuries; Multiple Sclerosis; Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Complex Regional Pain Syndromes; Autonomic Nervous System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Inclusion of patients with complex regional pain syndrome type I. In the past, there was no doubt that this disorder should be classified as classical neuropathic pain condition; Unmasking of blinding secondary to the psychoactive effects of cannabis

Results Point of Contact

• Title: Dr. Barth Wilsey, MD
• Organization: UCaliforniaDavis

blwilsey@ucdavis.edu

916-843-9082

Study Officials

• Barth L Wilsey, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 21, 2009
• Study Start: December 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 31, 2018
• Results First Posted: April 9, 2013

Record last verified: 2017-10

Locations

US (1)