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Effects of Smoked Marijuana on Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT00254761
Recruitment Status : Completed
First Posted : November 17, 2005
Last Update Posted : February 28, 2008
Sponsor:
Information provided by:
Center for Medicinal Cannabis Research

November 15, 2005
November 17, 2005
February 28, 2008
November 2003
February 2006   (Final data collection date for primary outcome measure)
Score on a series of pain scales (heat pain threshold, VAS intensity, VAS unpleasantness, pain relief, neuropathic pain scale).
Score on a series of pain scales (heat pain threshhold, VAS intensity, VAS unpleasantness, pain relief, neuropathic pain scale).
Complete list of historical versions of study NCT00254761 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Effects of Smoked Marijuana on Neuropathic Pain
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
To determine if smoking marijuana will reduce neuropathic pain without causing too much drowsiness or feeling "too dopey".

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).

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Neuropathic Pain
Drug: Cannabis
  • Experimental: 1
    High dose cannabis (7.5% THC by weight)
    Intervention: Drug: Cannabis
  • Experimental: 2
    Low dose cannabis (3.5% THC by weight)
    Intervention: Drug: Cannabis
  • Placebo Comparator: 3
    Placebo cannabis
    Intervention: Drug: Cannabis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
Same as current
February 2006
February 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00254761
C02-DA-114
Yes
Not Provided
Not Provided
Barth Wilsey, M.D., University of California, Davis
Center for Medicinal Cannabis Research
Not Provided
Principal Investigator: Barth L Wilsey, M.D. University of California, Davis
Center for Medicinal Cannabis Research
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP