Analgesic Efficacy of Smoked Cannabis - Full Text View

Sponsored by:	Center for Medicinal Cannabis Research
Information provided by:	Center for Medicinal Cannabis Research
ClinicalTrials.gov Identifier:	NCT00241579

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Analgesic Efficacy of Smoked Cannabis

Resource links provided by NLM:

Drug Information available for: GW-1000 Cannabis

U.S. FDA Resources

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

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

Additional Information:

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

No publications provided

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

Keywords provided by Center for Medicinal Cannabis Research:

Pain
Cannabis
Analgesic

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Somatosensory Disorders
Neurologic Manifestations

Pain
Peripheral Nervous System Agents
Analgesics
Hyperalgesia

Additional relevant MeSH terms:

Sensation Disorders
Nervous System Diseases
Physiological Effects of Drugs
Hyperalgesia
Pharmacologic Actions
Somatosensory Disorders
Signs and Symptoms

Sensory System Agents
Therapeutic Uses
Neurologic Manifestations
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009