Status:
WITHDRAWN
Investigating the Effect of Dronabinol on Post-surgical Pain
Lead Sponsor:
New York State Psychiatric Institute
Conditions:
Knee Replacement
Arthropathy of Knee
Eligibility:
All Genders
21-65 years
Phase:
EARLY_PHASE1
Brief Summary
This study is designed to investigate the effect of dronabinol on post operative pain in patients undergoing total knee replacement (for their own clinical care).
Detailed Description
Total knee replacement is a common surgical procedure that restores function to the damaged joint. Recovery from this procedure takes weeks and requires opioids to manage post-surgical pain. The goal ...
Eligibility Criteria
Inclusion
- Participants undergoing total knee arthroplasty (TKA) at the CUIMC department of orthopedic surgery as part of their clinical care.
- Able to give informed consent and comply with study procedures in English
Exclusion
- Meet DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, or psychosis. Subjects with a current substance use disorder will be excluded. Subjects with a past cannabis use disorder are excluded.
- Diagnosis of a major medical or neurological disorder, including orthostatic hypertension, cardiovascular disease (congestive heart failure, unstable angina, or a history of cardiac infarction), hypotension, or neurodegenerative disorders.
- Subjects taking medications that can lead to a drug interaction.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04099355
Start Date
September 1 2025
End Date
August 30 2027
Last Update
November 13 2023
Active Locations (1)
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1
1051 Riverside Drive
New York, New York, United States, 10032