Investigating the Effect of Dronabinol on Post-surgical Pain
Primary Purpose
Knee Replacement, Arthropathy of Knee
Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dronabinol 5mg Cap
Non-active comparator
Sponsored by
About this trial
This is an interventional treatment trial for Knee Replacement
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.
Sites / Locations
- 1051 Riverside Drive
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
dronabinol
control
Arm Description
active group
control group
Outcomes
Primary Outcome Measures
Brief Pain Inventory-Short Form
pain assessment, self report measure of pain, scale 0-10 (10 worst)
Secondary Outcome Measures
opioid medication log
opioid use by participant for pain after surgery
Full Information
NCT ID
NCT04099355
First Posted
September 19, 2019
Last Updated
October 11, 2022
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT04099355
Brief Title
Investigating the Effect of Dronabinol on Post-surgical Pain
Official Title
Investigating the Effect of Dronabinol on Post-surgical Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2030 (Anticipated)
Primary Completion Date
August 30, 2050 (Anticipated)
Study Completion Date
August 30, 2050 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Replacement, Arthropathy of Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dronabinol
Arm Type
Experimental
Arm Description
active group
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
control group
Intervention Type
Drug
Intervention Name(s)
Dronabinol 5mg Cap
Intervention Description
1 QAM and 2 QHS PO 14 days
Intervention Type
Drug
Intervention Name(s)
Non-active comparator
Intervention Description
1 QAM and 2 QHS PO 14 days
Primary Outcome Measure Information:
Title
Brief Pain Inventory-Short Form
Description
pain assessment, self report measure of pain, scale 0-10 (10 worst)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
opioid medication log
Description
opioid use by participant for pain after surgery
Time Frame
two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Martinez
Phone
646-774-7654
Email
dm437@columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Martinez, MD
Organizational Affiliation
NYSPI
Official's Role
Principal Investigator
Facility Information:
Facility Name
1051 Riverside Drive
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Martinez, MD
Phone
646-774-7654
Email
dm437@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Diana Martinez, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigating the Effect of Dronabinol on Post-surgical Pain
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