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Cannabinoid Modulation of Pain

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ClinicalTrials.gov Identifier: NCT01595620
Recruitment Status : Active, not recruiting
First Posted : May 10, 2012
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University

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
Pain Other: Thermal Device: Electrical Other: Capsaicin Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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
Study Start Date : December 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: THC 0.01 mg/kg Other: Thermal
Thermal sensation/pain testing
Device: Electrical
Electrical sensation/pain testing
Other: Capsaicin
Intradermal Capsaicin
Placebo Comparator: Placebo Other: Thermal
Thermal sensation/pain testing
Device: Electrical
Electrical sensation/pain testing
Other: Capsaicin
Intradermal Capsaicin
Active Comparator: THC 0.03 mg/kg Other: Thermal
Thermal sensation/pain testing
Device: Electrical
Electrical sensation/pain testing
Other: Capsaicin
Intradermal Capsaicin



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

Secondary Outcome Measures :
  1. Pain Measures [ Time Frame: On each test day at baseline (-30), peak (+20) and post (+120) drug administration ]
  2. Non-pain subjective responses [ Time Frame: On each test day at baseline (-30), peak (+20) and post (+120) drug administration ]
  3. Cognitive subjective responses [ Time Frame: On each test day at baseline (-30), peak (+20) and post (+120) drug administration ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595620


Locations
United States, Connecticut
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

Responsible Party: Deepak C. D'Souza, Professor, Yale University
ClinicalTrials.gov Identifier: NCT01595620     History of Changes
Other Study ID Numbers: 1005006859
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017

Keywords provided by Deepak C. D'Souza, Yale University:
Cannabis
THC
Pain

Additional relevant MeSH terms:
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs