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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04099355
Other study ID # 7815
Secondary ID
Status Withdrawn
Phase Early Phase 1
First received
Last updated
Start date September 1, 2025
Est. completion date August 30, 2027

Study information

Verified date November 2023
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 of this study is to investigate whether dronabinol (synthetic THC) can reduce pain and the need for opioid medication following this particular surgery. Subjects will be recruited from the Department of Orthopedic Surgery. All subjects will undergo total knee replacement as part of their clinical care (the surgery itself is not part of this study). The study begins following discharge from the hospital. They will be asked to take dronabinol or placebo as they recover from surgery. During this time they will be given their usual pain medications at discharge which includes opioids for pain. The opioids are to be taken if the subject is experiencing pain. The investigator's hypothesis is that subjects taking dronabinol will need fewer doses of opioids to control pain.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 30, 2027
Est. primary completion date August 30, 2027
Accepts healthy volunteers No
Gender All
Age group 21 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dronabinol 5mg Cap
1 QAM and 2 QHS PO 14 days
Non-active comparator
1 QAM and 2 QHS PO 14 days

Locations

Country Name City State
United States 1051 Riverside Drive New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brief Pain Inventory-Short Form pain assessment, self report measure of pain, scale 0-10 (10 worst) 2 weeks
Secondary opioid medication log opioid use by participant for pain after surgery two weeks
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