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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

Study Description
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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 Design
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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 : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
Contacts and Locations
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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
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United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Deepak C D'Souza, M.D. Yale University
More Information
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Responsible Party: Deepak C. D'Souza, Professor, Yale University
ClinicalTrials.gov Identifier: NCT01595620    
Other Study ID Numbers: 1005006859
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Keywords provided by Deepak C. D'Souza, Yale University:
Cannabis
THC
Pain
Additional relevant MeSH terms:
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Capsaicin
Antipruritics
Dermatologic Agents
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs