Investigating the Effect of Dronabinol on Post-surgical Pain

Early Phase 1

Withdrawn

• Conditions: Knee Replacement; Arthropathy of Knee
• Interventions: Drug: Dronabinol 5mg Cap; Drug: Non-active comparator

• Registration Number: NCT04099355
• Lead Sponsor: New York State Psychiatric Institute

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 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.

Study Timeline

• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-09-20
• Study First Posted: 2019-09-23
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13
• Study Start: 2025-09-01
• Primary Completion: 2027-08-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dronabinol	Non-active comparator	active group
control	Dronabinol 5mg Cap	control group
control	Non-active comparator	control group
dronabinol	Dronabinol 5mg Cap	active group

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory-Short Form	2 weeks	pain assessment, self report measure of pain, scale 0-10 (10 worst)

Secondary Outcome Measures

Name	Time	Method
opioid medication log	two weeks	opioid use by participant for pain after surgery

Trial Locations

Locations (1)

1051 Riverside Drive; 🇺🇸 New York, New York, United States