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Clinical trial

Investigating the Effect of Dronabinol on Post-surgical Pain

ID
Name
7815
Description
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).
Trial arms
Trial start
2025-09-01
Estimated PCD
2027-08-30
Trial end
2027-08-30
Status
Withdrawn
Phase
Early phase I
Treatment
Dronabinol 5mg Cap
1 QAM and 2 QHS PO 14 days
Arms:
control, dronabinol
Non-active comparator
1 QAM and 2 QHS PO 14 days
Arms:
control, dronabinol
Primary endpoint
Brief Pain Inventory-Short Form
2 weeks
Eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2023-11-13

1 organization

2 products

2 indications

Organization
New York State Psychiatric Institute
Product
Dronabinol
Indication
Knee Replacement
Indication
Arthropathy of Knee
Product
Non-active comparator