Investigating the Effect of Dronabinol on Post-surgical Pain

Arthropathy of Knee Clinical Trial

Official title:

Investigating the Effect of Dronabinol on Post-surgical Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04099355
• Other study ID #: 7815
• Status: Withdrawn
• Phase: Early Phase 1
• 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
• 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• Status: Withdrawn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.

Related Conditions & MeSH terms

• Arthropathy of Knee
• Knee Replacement
• Pain, Postoperative

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