Cannabinoid Modulation of Pain
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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 : January 8, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain | Other: Thermal Device: Electrical Other: Capsaicin | Not Applicable |
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 2021 |
Estimated Study Completion Date : | December 2021 |

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

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
United States, Connecticut | |
VA Connecticut Healthcare System | |
West Haven, Connecticut, United States, 06516 |
Principal Investigator: | Deepak C D'Souza, M.D. | Yale University |
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: | January 8, 2021 |
Last Verified: | January 2021 |
Cannabis THC Pain |
Capsaicin Antipruritics Dermatologic Agents |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |