Analgesic Efficacy of Smoked Cannabis
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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 |
- 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.
- 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 |
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 |
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| United States, California | |
| UC San Diego Medical Center | |
| San Diego, California, United States, 92093 | |
| Principal Investigator: | Mark Wallace, M.D. | University of California, San Diego |
More Information
Additional 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:
|
Hyperalgesia Somatosensory Disorders Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms 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 May 23, 2013