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Cannabinoid Modulation of Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01595620
Recruitment Status : Active, not recruiting
First Posted : May 10, 2012
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University

Tracking Information
First Submitted Date  ICMJE April 25, 2012
First Posted Date  ICMJE May 10, 2012
Last Update Posted Date December 18, 2019
Study Start Date  ICMJE December 2011
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2012)
Capsaicin-induced hyperalgesia [ Time Frame: On each test day at baseline (-30), peak (+20) and post (+120) drug administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabinoid Modulation of Pain
Official Title  ICMJE Cannabinoid Modulation of Pain
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Pain
Intervention  ICMJE
  • Other: Thermal
    Thermal sensation/pain testing
  • Device: Electrical
    Electrical sensation/pain testing
  • Other: Capsaicin
    Intradermal Capsaicin
Study Arms  ICMJE
  • Active Comparator: THC 0.01 mg/kg
    Interventions:
    • Other: Thermal
    • Device: Electrical
    • Other: Capsaicin
  • Placebo Comparator: Placebo
    Interventions:
    • Other: Thermal
    • Device: Electrical
    • Other: Capsaicin
  • Active Comparator: THC 0.03 mg/kg
    Interventions:
    • Other: Thermal
    • Device: Electrical
    • Other: Capsaicin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2012)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01595620
Other Study ID Numbers  ICMJE 1005006859
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Deepak C. D'Souza, Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Deepak C D'Souza, M.D. Yale University
PRS Account Yale University
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP