We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Effects of Smoked Marijuana on Neuropathic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00254761
Recruitment Status : Completed
First Posted : November 17, 2005
Last Update Posted : February 28, 2008
Information provided by:
Center for Medicinal Cannabis Research

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

Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: Cannabis Phase 1 Phase 2

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
Study Start Date : November 2003
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254761

Layout table for location information
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
Center for Medicinal Cannabis Research
Layout table for investigator information
Principal Investigator: Barth L Wilsey, M.D. University of California, Davis
Additional Information:
Layout table for additonal information
Responsible Party: Barth Wilsey, M.D., University of California, Davis
ClinicalTrials.gov Identifier: NCT00254761    
Other Study ID Numbers: C02-DA-114
First Posted: November 17, 2005    Key Record Dates
Last Update Posted: February 28, 2008
Last Verified: February 2008
Keywords provided by Center for Medicinal Cannabis Research:
Additional relevant MeSH terms:
Layout table for MeSH terms
Marijuana Abuse
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders