Cannabinoid Modulation of Pain
This study is currently recruiting participants.
Verified May 2013 by Yale University
Sponsor:
Yale University
Information provided by (Responsible Party):
R. Andrew Sewell, Yale University
ClinicalTrials.gov Identifier:
NCT01595620
First received: April 25, 2012
Last updated: May 8, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to test the effects of cannabinoids on pain response using a variety of human experimental pain models. The study has two phases, Phase 1 (in which THC is administered after capsaicin in healthy subjects), and Phase 2 (separate sub-studies in which chronic cannabis smokers are enrolled and the capsaicin is administered after rather than before THC).
| 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 4523 lawrence.rispoli@yale.edu | |
| Principal Investigator: Richard A Sewell, M.D. | |
| Sub-Investigator: Deepak C D'Souza, M.D. | |
Sponsors and Collaborators
Yale University
Investigators
| Principal Investigator: | Richard A Sewell, M.D. | Yale University |
More Information
No publications provided
| Responsible Party: | R. Andrew Sewell, Associate Professor, Yale University |
| ClinicalTrials.gov Identifier: | NCT01595620 History of Changes |
| Other Study ID Numbers: | 1005006859 |
| Study First Received: | April 25, 2012 |
| Last Updated: | May 8, 2013 |
| 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 May 22, 2013