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NCT01595620 Clinical Trial

Cannabinoid Modulation of Pain

Pain Clinical Trial

Official title:
Cannabinoid Modulation of Pain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01595620
Other study ID # 1005006859
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date November 9, 2011
Est. completion date April 19, 2012

Study information
Verified date February 2022
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test the effects of cannabinoids on pain response using a variety of human experimental pain models.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date April 19, 2012
Est. primary completion date April 19, 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - At least one lifetime exposure to cannabis - Acceptable Birth Control methods for females Exclusion Criteria: - Cannabis naive - Medical or psychiatric contraindications - Analgesic medication - Previous sensitivity to THC or cannabis

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Thermal
Thermal sensation/pain testing
• Electrical
Electrical sensation/pain testing
• Capsaicin
Intradermal Capsaicin
Drug:
• THC
Active THC (0.01 mg/kg) administered over 10 minutes
• THC
Active THC (0.03 mg/kg) administered over 10 minutes
• Placebo
Control: small amount of alcohol with no THC, administered over 10 minutes

Locations
Country Name City State
United States VA Connecticut Healthcare System West Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Capsaicin-induced hyperalgesia On each test day at baseline (-30), peak (+20) and post (+120) drug administration
Secondary Pain Measures On each test day at baseline (-30), peak (+20) and post (+120) drug administration
Secondary Non-pain subjective responses On each test day at baseline (-30), peak (+20) and post (+120) drug administration
Secondary Cognitive subjective responses On each test day at baseline (-30), peak (+20) and post (+120) drug administration
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