Cannabinoid Modulation of Pain

This study is currently recruiting participants.
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: April 1, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595620

Contacts
Contact: Lawrence V Rispoli, B.A. 203-932-5711 ext 2526 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 2526    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: April 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
Cannabis
THC
Pain

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

ClinicalTrials.gov processed this record on April 17, 2014