Effects of Smoked Marijuana on Neuropathic Pain

This study has been completed.
Sponsor:
Information provided by:
Center for Medicinal Cannabis Research
ClinicalTrials.gov Identifier:
NCT00254761
First received: November 15, 2005
Last updated: February 27, 2008
Last verified: February 2008
  Purpose

To determine if smoking marijuana will reduce neuropathic pain without causing too much drowsiness or feeling "too dopey".


Condition Intervention Phase
Neuropathic Pain
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: A Double Blind, Active Placebo Controlled Crossover Trial of the Antinociceptive Effect of Smoked Marijuana on Subjects With Neuropathic Pain; Correlation With Changes in Mood, Cognition, and Psychomotor Performance

Resource links provided by NLM:


Further study details as provided by Center for Medicinal Cannabis Research:

Primary Outcome Measures:
  • Score on a series of pain scales (heat pain threshold, VAS intensity, VAS unpleasantness, pain relief, neuropathic pain scale).

Secondary Outcome Measures:
  • Number of subjects who are unable to tolerate the high dose without significant side effects.
  • Changes in mood, cognitive impairment, and psychomotor performance (mood - VAS happiness, cognition - Digit Symbol Modalities Test, psychomotor performance - Grooved Pegboard Test).

Enrollment: 28
Study Start Date: November 2003
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
High dose cannabis (7.5% THC by weight)
Drug: Cannabis
Experimental: 2
Low dose cannabis (3.5% THC by weight)
Drug: Cannabis
Placebo Comparator: 3
Placebo cannabis
Drug: Cannabis

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:

  • Able to understand English
  • Age greater than 18 and less than 70
  • VAS greater than 3/10
  • History of previous marijuana use (i.e., avoidance of marijuana naive subjects)
  • Negative urine drug screening test
  • Nerve Injury a.k.a. Complex Regional Pain Syndrome Type II OR
  • Complex Regional Pain Syndrome Type I OR
  • Neuropathic pain due to confirmed bilateral distal peripheral neuropathy associated with Diabetes I or II, focal nerve injury, postherpetic neuralgia, spinal cord injury with incomplete myelopathy, central pain following a stroke or focal brain lesion, or clinical definite multiple sclerosis of at least 3 months duration.

Exclusion Criteria:

  • Presence of another painful condition of greater severity than the neuropathic pain condition which is being studied
  • Unstable Type 1 or 2 diabetes defined as blood glucose more than 156 mg/dl
  • For diabetic subjects maintained on insulin with a stable blood glucose more than 156 mg/dl, a hemoglobin A1C level of more than 0.11 (normal range, 0.048-0.067)
  • History of traumatic brain injury
  • History of schizophrenia or a past or current history of a serious psychiatric disorder that is currently not well controlled with medications
  • Uncontrolled medical condition - coronary artery disease, hypertension, cerebrovascular disease, asthma, TB, COPD, opportunistic infection, malignancy requiring active treatment
  • Active substance abuse (alcohol or injection drugs)
  • Current use of marijuana (within 30 days of randomization) as determined by urine screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254761

Locations
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
Center for Medicinal Cannabis Research
Investigators
Principal Investigator: Barth L Wilsey, M.D. University of California, Davis
  More Information

Additional Information:
No publications provided

Responsible Party: Barth Wilsey, M.D., University of California, Davis
ClinicalTrials.gov Identifier: NCT00254761     History of Changes
Other Study ID Numbers: C02-DA-114
Study First Received: November 15, 2005
Last Updated: February 27, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Center for Medicinal Cannabis Research:
cannabis
marijuana
neuropathy
antinociception
mood
cognition

Additional relevant MeSH terms:
Marijuana Abuse
Neuralgia
Substance-Related Disorders
Mental Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014