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Investigating the Effect of Dronabinol on Post-surgical Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099355
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Diana Martinez, 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).

Condition or disease Intervention/treatment Phase
Arthropathy of Knee Drug: Dronabinol Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigating the Effect of Dronabinol on Post-surgical Pain
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : August 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arm Intervention/treatment
Experimental: dronabinol
active group
Drug: Dronabinol
PO

Placebo Comparator: control
control group
Drug: Dronabinol
PO




Primary Outcome Measures :
  1. Brief Pain Inventory-Short Form [ Time Frame: 2 weeks ]
    pain assessment, self report measure of pain


Secondary Outcome Measures :
  1. opioid medication log [ Time Frame: two weeks ]
    opioid use by participant for pain after surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099355


Contacts
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Contact: Diana Martinez 646-774-7654 dm437@columbia.edu

Locations
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United States, New York
1051 Riverside Drive Recruiting
New York, New York, United States, 10032
Contact: Diana Martinez, MD    646-774-7654    dm437@cumc.columbia.edu   
Principal Investigator: Diana Martinez, M.D.         
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
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Principal Investigator: Diana Martinez, MD NYSPI
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Responsible Party: Diana Martinez, Psychiatrist II, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT04099355    
Other Study ID Numbers: 7815
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists