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Completed

NCT Number: NCT00254761

Effects of Smoked Marijuana on Neuropathic Pain

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cannabis

Drug

Primary outcomes

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

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Center for Medicinal Cannabis Research

Other

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Nov 17, 2005
Registry last updated
Feb 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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