search
Back to results

Effects of Smoked Marijuana on Neuropathic Pain

Primary Purpose

Neuropathic Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cannabis
Sponsored by
Center for Medicinal Cannabis Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring cannabis, marijuana, neuropathy, antinociception, mood, cognition

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Davis Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

High dose cannabis (7.5% THC by weight)

Low dose cannabis (3.5% THC by weight)

Placebo cannabis

Outcomes

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).

Full Information

First Posted
November 15, 2005
Last Updated
February 27, 2008
Sponsor
Center for Medicinal Cannabis Research
search

1. Study Identification

Unique Protocol Identification Number
NCT00254761
Brief Title
Effects of Smoked Marijuana on Neuropathic Pain
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 Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Center for Medicinal Cannabis Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
cannabis, marijuana, neuropathy, antinociception, mood, cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
High dose cannabis (7.5% THC by weight)
Arm Title
2
Arm Type
Experimental
Arm Description
Low dose cannabis (3.5% THC by weight)
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo cannabis
Intervention Type
Drug
Intervention Name(s)
Cannabis
Primary Outcome Measure Information:
Title
Score on a series of pain scales (heat pain threshold, VAS intensity, VAS unpleasantness, pain relief, neuropathic pain scale).
Secondary Outcome Measure Information:
Title
Number of subjects who are unable to tolerate the high dose without significant side effects.
Title
Changes in mood, cognitive impairment, and psychomotor performance (mood - VAS happiness, cognition - Digit Symbol Modalities Test, psychomotor performance - Grooved Pegboard Test).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barth L Wilsey, M.D.
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cmcr.ucsd.edu
Description
Center For Medicinal Cannabis Research

Learn more about this trial

Effects of Smoked Marijuana on Neuropathic Pain

We'll reach out to this number within 24 hrs