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Cannabinoid Modulation of Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University
ClinicalTrials.gov Identifier:
NCT01595620
First received: April 25, 2012
Last updated: February 2, 2017
Last verified: February 2017
  Purpose
The purpose of this study is to test the effects of cannabinoids on pain response using a variety of human experimental pain models.

Condition Intervention Phase
Pain
Other: Thermal
Device: Electrical
Other: Capsaicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Health Services Research
Official Title: Cannabinoid Modulation of Pain

Resource links provided by NLM:


Further study details as provided by Yale University:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: December 2011
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Deepak C. D'Souza, Professor, Yale University
ClinicalTrials.gov Identifier: NCT01595620     History of Changes
Other Study ID Numbers: 1005006859 
Study First Received: April 25, 2012
Last Updated: February 2, 2017

Keywords provided by Yale University:
Cannabis
THC
Pain

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

ClinicalTrials.gov processed this record on March 01, 2017