Effects of Smoked Marijuana on Neuropathic Pain - Full Text View

Sponsored by:	Center for Medicinal Cannabis Research
Information provided by:	Center for Medicinal Cannabis Research
ClinicalTrials.gov Identifier:	NCT00254761

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 I Phase II

MedlinePlus related topics: Marijuana

Drug Information available for: GW-1000 Cannabis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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

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
1: Experimental High dose cannabis (7.5% THC by weight)	Drug: Cannabis
2: Experimental Low dose cannabis (3.5% THC by weight)	Drug: Cannabis
3: Placebo Comparator 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

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:

Center For Medicinal Cannabis Research This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Center for Medicinal Cannabis Research:

cannabis
marijuana
neuropathy

antinociception
mood
cognition

Study placed in the following topic categories:

Pain
Marijuana Abuse

ClinicalTrials.gov processed this record on May 07, 2009