Analgesic Efficacy of Smoked Cannabis
Primary Purpose
Pain, Hyperalgesia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Smoked Cannabis
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Pain, Cannabis, Analgesic
Eligibility Criteria
Inclusion Criteria: Age 18-90 Male or Female Subject smoked cannabis within the last six months Exclusion Criteria: Active opportunistic infections or opportunistic malignancies requiring acute treatment Active substance abuse (alcohol or injection drug) Pulmonary complications (e.g., tuberculosis, asthma) Current use of cannabis (e.g., within 30 days of randomization) Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test before any cannabis or placebo consumption condition Personal or familial history of psychiatric disorder
Sites / Locations
- UC San Diego Medical Center
Outcomes
Primary Outcome Measures
Score on a Visual Analog Scale (VAS) of pain severity
McGill Pain Questionnaire (MPQ) Short Form
Neurosensory testing of: 1) warm and cold sensation, 2) warm and cold pain, 3) touch, and 4) mechanical pain. Testing administered using a Thermal Sensory Analyzer, von Frey hair filaments, and a pinch algometer, respectively.
Secondary Outcome Measures
Trail Making Test (TMT) as a measure of psychomotor speed.
Paced Auditory Serial Attention Test (PASAT) as a measure of speed of information processing.
Full Information
NCT ID
NCT00241579
First Posted
October 17, 2005
Last Updated
June 21, 2006
Sponsor
Center for Medicinal Cannabis Research
1. Study Identification
Unique Protocol Identification Number
NCT00241579
Brief Title
Analgesic Efficacy of Smoked Cannabis
Official Title
Analgesic Efficacy of Smoked Cannabis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Center for Medicinal Cannabis Research
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether or not inhaled marijuana displays any pain-relieving properties on experimentally-induced pain.
Detailed Description
It is important to evaluate the effects of the cannabinoids on facilitated pain as conditions of hyperalgesia more closely approximates the clinical situation. There are limited clinical studies on the effect of the cannabinoids on facilitated pain states. Noyes et al evaluated the analgesic effects of Delta-9-THC in 34 cancer patients with pain. They concluded that 20mg of oral Delta-9-THC was similar to 120mg of codeine (Noyes et al, 1975). Jain et al concluded that 1.5-3mg of intramuscular Levonantradol resulted in significant pain relief as compared to placebo in 56 patients with acute postoperative pain (Jain et al, 1981).
Comparison(s): Three different doses of smoked cannabis will be compared to placebo for the reduction of experimentally induced pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Hyperalgesia
Keywords
Pain, Cannabis, Analgesic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
15 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Smoked Cannabis
Primary Outcome Measure Information:
Title
Score on a Visual Analog Scale (VAS) of pain severity
Title
McGill Pain Questionnaire (MPQ) Short Form
Title
Neurosensory testing of: 1) warm and cold sensation, 2) warm and cold pain, 3) touch, and 4) mechanical pain. Testing administered using a Thermal Sensory Analyzer, von Frey hair filaments, and a pinch algometer, respectively.
Secondary Outcome Measure Information:
Title
Trail Making Test (TMT) as a measure of psychomotor speed.
Title
Paced Auditory Serial Attention Test (PASAT) as a measure of speed of information processing.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18-90
Male or Female
Subject smoked cannabis within the last six months
Exclusion Criteria:
Active opportunistic infections or opportunistic malignancies requiring acute treatment
Active substance abuse (alcohol or injection drug)
Pulmonary complications (e.g., tuberculosis, asthma)
Current use of cannabis (e.g., within 30 days of randomization)
Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test before any cannabis or placebo consumption condition
Personal or familial history of psychiatric disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Wallace, M.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Links:
URL
http://cmcr.ucsd.edu
Description
Center for Medicinal Cannabis Research
Learn more about this trial
Analgesic Efficacy of Smoked Cannabis
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