Investigating the Effect of Dronabinol on Post-surgical Pain

NCT ID: NCT04099355

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-08-30

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.

Conditions

Knee Replacement; Arthropathy of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

dronabinol

active group

Group Type: EXPERIMENTAL

Dronabinol 5mg Cap

Intervention Type: DRUG

1 QAM and 2 QHS PO 14 days

Non-active comparator

Intervention Type: DRUG

1 QAM and 2 QHS PO 14 days

control

control group

Group Type: PLACEBO_COMPARATOR

Dronabinol 5mg Cap

Intervention Type: DRUG

1 QAM and 2 QHS PO 14 days

Non-active comparator

Intervention Type: DRUG

1 QAM and 2 QHS PO 14 days

Interventions

Dronabinol 5mg Cap

1 QAM and 2 QHS PO 14 days

Intervention Type: DRUG

Non-active comparator

1 QAM and 2 QHS PO 14 days

Intervention Type: DRUG

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Diana Martinez

Psychiatrist II

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diana Martinez, MD

Role: PRINCIPAL_INVESTIGATOR

NYSPI

Locations

1051 Riverside Drive

New York, New York, United States

Countries

United States

Other Identifiers

7815

Identifier Type: -

Identifier Source: org_study_id