Analgesic Efficacy of Smoked Cannabis

This study has been completed.
Sponsor:
Information provided by:
Center for Medicinal Cannabis Research
ClinicalTrials.gov Identifier:
NCT00241579
First received: October 17, 2005
Last updated: June 21, 2006
Last verified: June 2006
  Purpose

The purpose of this study is to determine whether or not inhaled marijuana displays any pain-relieving properties on experimentally-induced pain.


Condition Intervention Phase
Pain
Hyperalgesia
Drug: Smoked Cannabis
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Analgesic Efficacy of Smoked Cannabis

Resource links provided by NLM:


Further study details as provided by Center for Medicinal Cannabis Research:

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.

Estimated Enrollment: 15
Study Start Date: February 2002
Estimated Study Completion Date: January 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241579

Locations
United States, California
UC San Diego Medical Center
San Diego, California, United States, 92093
Sponsors and Collaborators
Center for Medicinal Cannabis Research
Investigators
Principal Investigator: Mark Wallace, M.D. University of California, San Diego
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00241579     History of Changes
Other Study ID Numbers: C00-SD-107, 021422
Study First Received: October 17, 2005
Last Updated: June 21, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Center for Medicinal Cannabis Research:
Pain
Cannabis
Analgesic

Additional relevant MeSH terms:
Marijuana Abuse
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014