Analgesic Efficacy of Smoked Cannabis

Pain Clinical Trial

Official title:

Analgesic Efficacy of Smoked Cannabis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241579
• Other study ID #: C00-SD-107
• Secondary ID: 021422
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 17, 2005
• Last updated: June 21, 2006
• Start date: February 2002
• Est. completion date: January 2004

Study information

• Verified date: June 2006
• Source: Center for Medicinal Cannabis Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperalgesia
• Pain

Intervention

Drug:
• Smoked Cannabis

Locations

Country	Name	City	State
United States	UC San Diego Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Center for Medicinal Cannabis Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on a Visual Analog Scale (VAS) of pain severity
Primary	McGill Pain Questionnaire (MPQ) Short Form
Primary	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	Trail Making Test (TMT) as a measure of psychomotor speed.
Secondary	Paced Auditory Serial Attention Test (PASAT) as a measure of speed of information processing.

External Links

•   Center for Medicinal Cannabis Research