Investigating the Effect of Dronabinol on Post-surgical Pain

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Replacement; Arthropathy of Knee
• Intervention / Treatment: Drug: Dronabinol 5mg Cap; Drug: Non-active comparator

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Diana Martinez; Phone Number: 646-774-7654; Email: dm437@columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • 1051 Riverside Drive
      • Contact: Diana Martinez, MD; Phone Number: 646-774-7654; Email: dm437@cumc.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control; control group	Drug: Dronabinol 5mg Cap; 1 QAM and 2 QHS PO 14 days; Drug: Non-active comparator; 1 QAM and 2 QHS PO 14 days
Experimental: dronabinol; active group	Drug: Dronabinol 5mg Cap; 1 QAM and 2 QHS PO 14 days; Drug: Non-active comparator; 1 QAM and 2 QHS PO 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory-Short Form	pain assessment, self report measure of pain, scale 0-10 (10 worst)	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid medication log	opioid use by participant for pain after surgery	two weeks

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Investigators: Principal Investigator: Diana Martinez, MD, NYSPI

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2030
• Primary Completion (Anticipated): August 30, 2050
• Study Completion (Anticipated): August 30, 2050

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 20, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol
• Other Study ID Numbers: 7815 (CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No