Overview

This trial is active, not recruiting.

Condition pain
Treatments thermal, electrical, capsaicin
Phase phase 2
Sponsor Yale University
Start date December 2011
End date December 2016
Trial size 120 participants
Trial identifier NCT01595620, 1005006859

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose health services research
Arm
(Active Comparator)
thermal
Thermal sensation/pain testing
electrical
Electrical sensation/pain testing
capsaicin
Intradermal Capsaicin
(Placebo Comparator)
thermal
Thermal sensation/pain testing
electrical
Electrical sensation/pain testing
capsaicin
Intradermal Capsaicin
(Active Comparator)
thermal
Thermal sensation/pain testing
electrical
Electrical sensation/pain testing
capsaicin
Intradermal Capsaicin

Primary Outcomes

Measure
Capsaicin-induced hyperalgesia
time frame: On each test day at baseline (-30), peak (+20) and post (+120) drug administration

Secondary Outcomes

Measure
Pain Measures
time frame: On each test day at baseline (-30), peak (+20) and post (+120) drug administration
Non-pain subjective responses
time frame: On each test day at baseline (-30), peak (+20) and post (+120) drug administration
Cognitive subjective responses
time frame: On each test day at baseline (-30), peak (+20) and post (+120) drug administration

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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

Additional Information

Official title Cannabinoid Modulation of Pain
Principal investigator Deepak C D'Souza, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Yale University.