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Cannabinoid Modulation of Pain

Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT01595620
Collaborator
(none)
6
Enrollment
1
Location
3
Arms
5.3
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Cannabinoid Modulation of Pain
Actual Study Start Date :
Nov 9, 2011
Actual Primary Completion Date :
Apr 19, 2012
Actual Study Completion Date :
Apr 19, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: THC 0.01 mg/kg

Other: Thermal
Thermal sensation/pain testing

Other: Electrical
Electrical sensation/pain testing

Other: Capsaicin
Intradermal Capsaicin

Drug: THC
Active THC (0.01 mg/kg) administered over 10 minutes
Other Names:
  • Delta-9-tetrahydrocannabinol

    		•
    Placebo Comparator: Placebo

    Other: Thermal
    Thermal sensation/pain testing

    Other: Electrical
    Electrical sensation/pain testing

    Other: Capsaicin
    Intradermal Capsaicin

    Drug: Placebo
    Control: small amount of alcohol with no THC, administered over 10 minutes
    Active Comparator: THC 0.03 mg/kg

    Other: Thermal
    Thermal sensation/pain testing

    Other: Electrical
    Electrical sensation/pain testing

    Other: Capsaicin
    Intradermal Capsaicin

    Drug: THC
    Active THC (0.03 mg/kg) administered over 10 minutes
    Other Names:
  • Delta-9-tetrahydrocannabinol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Capsaicin-induced hyperalgesia [On each test day at baseline (-30), peak (+20) and post (+120) drug administration]

    Secondary Outcome Measures

    1. Pain Measures [On each test day at baseline (-30), peak (+20) and post (+120) drug administration]

    2. Non-pain subjective responses [On each test day at baseline (-30), peak (+20) and post (+120) drug administration]

    3. Cognitive subjective responses [On each test day at baseline (-30), peak (+20) and post (+120) drug administration]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 VA Connecticut Healthcare System West Haven Connecticut United States 06516

    Sponsors and Collaborators

    • Yale University

    Investigators

    • Principal Investigator: Deepak C D'Souza, M.D., Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Deepak C. D'Souza, Professor, Yale University
    ClinicalTrials.gov Identifier:
    NCT01595620
    Other Study ID Numbers:
    • 1005006859
    First Posted:
    May 10, 2012
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Deepak C. D'Souza, Professor, Yale University
    Cannabis
    THC
    Pain
    Additional relevant MeSH terms:
    Dronabinol
    Capsaicin

    Study Results

    No Results Posted as of Mar 9, 2022