Cannabinoid Modulation of Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University
ClinicalTrials.gov Identifier:
NCT01595620
First received: April 25, 2012
Last updated: July 17, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Measures [ Time Frame: On each test day at baseline (-30), peak (+20) and post (+120) drug administration ] [ Designated as safety issue: No ]
  • Non-pain subjective responses [ Time Frame: On each test day at baseline (-30), peak (+20) and post (+120) drug administration ] [ Designated as safety issue: No ]
  • Cognitive subjective responses [ Time Frame: On each test day at baseline (-30), peak (+20) and post (+120) drug administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Lawrence V Rispoli, B.A. 203-932-5711 ext 4525 lawrence.rispoli@yale.edu

Locations
United States, Connecticut
VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Lawrence V Rispoli, B.A.    203-932-5711 ext 4525    lawrence.rispoli@yale.edu   
Principal Investigator: Deepak C D'Souza, M.D.         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Deepak C D'Souza, M.D. Yale University
  More Information

No publications provided

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: July 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
Cannabis
THC
Pain

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

ClinicalTrials.gov processed this record on August 26, 2014