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A RCT Comparing Dronabinol to a Placebo for Post-operative Pain in Total Joint Arthroplasty (dronabinol)

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dronabinol
Placebo
Sponsored by
Colorado Joint Replacement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provision of signed and dated informed consent from
  • Stated willingness to comply with all study procedures and availability to attend all required visits for the duration of the study.
  • Male or Female
  • Age 21-75
  • Unilateral total knee arthroplasty at Colorado Joint Replacement
  • All individuals will be screened for drug use (including cannabis) at their preoperative appointment
  • Ability to take oral medication and be willing to adhere to the dronabinol regimen
  • For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
  • For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.

Exclusion Criteria:

  • Narcotic use in the past 6 weeks
  • Regular cannabis use in the past 3 months
  • Major depression or anxiety disorders
  • Documented psychiatric illness (e.g. bipolar, schizophrenia)
  • Seizure disorder
  • Current or previous history of drug and alcohol abuse
  • Known allergic reactions to components of dronabinol
  • Tobacco use in the past 90 days
  • Treatment with another investigational drug
  • Patients that cannot receive spinal anesthesia
  • Patients that cannot receive the standardized multimodal pain medications (i.e. Tylenol, gabapentin and meloxicam)
  • Patients that are not able to go home after leaving the hospital and require a short term rehabilitation facility

Sites / Locations

  • Colorado Joint ReplacementRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

dronabinol

placebo

Arm Description

Patient will be directed to take 2.5mg of Study Drug 2 times a day for 4 weeks. Patient is blinded as to whether or not this is Dronabinol.

Patient will be directed to take 2.5mg of Study Drug 2 times a day for 4 weeks. Patient is blinded as to whether or not this is Dronabinol.

Outcomes

Primary Outcome Measures

Morphine Equivalence
Morphine Equivalence of pain medication used after a total knee replacement

Secondary Outcome Measures

Nausea
Patients post operative nausea will be collected as none/mild/moderate/severe
Defense and Veterans Pain Scale
Patients will keep a pain log after their joint replacement on a scale of 0 - 10
The Pittsburgh Sleep Quality Index
To monitor sleeping habits
Knee Society Score
Patient reported outcome
KOOS-12 Knee Survey
Patient reported outcome
The Veterans Rand 12-Item Health Survey
Patient reported outcome

Full Information

First Posted
March 4, 2020
Last Updated
January 6, 2023
Sponsor
Colorado Joint Replacement
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1. Study Identification

Unique Protocol Identification Number
NCT04298528
Brief Title
A RCT Comparing Dronabinol to a Placebo for Post-operative Pain in Total Joint Arthroplasty
Acronym
dronabinol
Official Title
A Prospective, Randomized, Double Blind Trial Comparing Dronabinol to a Placebo in the Management of Post-operative Pain in Total Joint Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 5, 2020 (Actual)
Primary Completion Date
February 5, 2024 (Anticipated)
Study Completion Date
February 5, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Colorado Joint Replacement

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
The primary purpose of this study was to determine if cannabinoid use decreases narcotic consumption in patients undergoing total knee arthroplasty (TKA).
Detailed Description
Subjects enrolled will be randomized into one of two groups either receiving the study drug or a placebo and will be followed for the first 6 weeks with regards to outcomes data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dronabinol
Arm Type
Experimental
Arm Description
Patient will be directed to take 2.5mg of Study Drug 2 times a day for 4 weeks. Patient is blinded as to whether or not this is Dronabinol.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Patient will be directed to take 2.5mg of Study Drug 2 times a day for 4 weeks. Patient is blinded as to whether or not this is Dronabinol.
Intervention Type
Drug
Intervention Name(s)
Dronabinol
Other Intervention Name(s)
Marinol
Intervention Description
2.5mg 2 times a day for 30 days after total knee replacement
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Lactose
Intervention Description
2 times a day for 30 days after total knee replacement
Primary Outcome Measure Information:
Title
Morphine Equivalence
Description
Morphine Equivalence of pain medication used after a total knee replacement
Time Frame
30 day's post operative
Secondary Outcome Measure Information:
Title
Nausea
Description
Patients post operative nausea will be collected as none/mild/moderate/severe
Time Frame
30 day's post operative
Title
Defense and Veterans Pain Scale
Description
Patients will keep a pain log after their joint replacement on a scale of 0 - 10
Time Frame
30 day's post operative
Title
The Pittsburgh Sleep Quality Index
Description
To monitor sleeping habits
Time Frame
4 weeks and 6 weeks post operative
Title
Knee Society Score
Description
Patient reported outcome
Time Frame
4 weeks post operative
Title
KOOS-12 Knee Survey
Description
Patient reported outcome
Time Frame
6 weeks post operative
Title
The Veterans Rand 12-Item Health Survey
Description
Patient reported outcome
Time Frame
6 weeks post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent from Stated willingness to comply with all study procedures and availability to attend all required visits for the duration of the study. Male or Female Age 21-75 Unilateral total knee arthroplasty at Colorado Joint Replacement All individuals will be screened for drug use (including cannabis) at their preoperative appointment Ability to take oral medication and be willing to adhere to the dronabinol regimen For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner. Exclusion Criteria: Narcotic use in the past 6 weeks Regular cannabis use in the past 3 months Major depression or anxiety disorders Documented psychiatric illness (e.g. bipolar, schizophrenia) Seizure disorder Current or previous history of drug and alcohol abuse Known allergic reactions to components of dronabinol Tobacco use in the past 90 days Treatment with another investigational drug Patients that cannot receive spinal anesthesia Patients that cannot receive the standardized multimodal pain medications (i.e. Tylenol, gabapentin and meloxicam) Patients that are not able to go home after leaving the hospital and require a short term rehabilitation facility
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rose Johnson
Phone
3032602940
Email
roseannjohnson@centura.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason M Jennings, MD DPT
Organizational Affiliation
Colorado Joint Replacement
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado Joint Replacement
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roseann Johnson
Phone
303-260-2940
Email
RoseannJohnson@centura.org
First Name & Middle Initial & Last Name & Degree
Jason Jennings, MD
First Name & Middle Initial & Last Name & Degree
Douglas Dennis, MD
First Name & Middle Initial & Last Name & Degree
Todd Miner, MD
First Name & Middle Initial & Last Name & Degree
Charlie Yang, MD
First Name & Middle Initial & Last Name & Degree
Mauricio Mejia, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30799266
Citation
Hannon CP, Calkins TE, Li J, Culvern C, Darrith B, Nam D, Gerlinger TL, Buvanendran A, Della Valle CJ. The James A. Rand Young Investigator's Award: Large Opioid Prescriptions Are Unnecessary After Total Joint Arthroplasty: A Randomized Controlled Trial. J Arthroplasty. 2019 Jul;34(7S):S4-S10. doi: 10.1016/j.arth.2019.01.065. Epub 2019 Feb 4.
Results Reference
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PubMed Identifier
30794232
Citation
Jennings JM, Williams MA, Levy DL, Johnson RM, Eschen CL, Dennis DA. Has Self-reported Marijuana Use Changed in Patients Undergoing Total Joint Arthroplasty After the Legalization of Marijuana? Clin Orthop Relat Res. 2019 Jan;477(1):95-100. doi: 10.1097/CORR.0000000000000339.
Results Reference
background
PubMed Identifier
30170713
Citation
Hickernell TR, Lakra A, Berg A, Cooper HJ, Geller JA, Shah RP. Should Cannabinoids Be Added to Multimodal Pain Regimens After Total Hip and Knee Arthroplasty? J Arthroplasty. 2018 Dec;33(12):3637-3641. doi: 10.1016/j.arth.2018.07.027. Epub 2018 Aug 3.
Results Reference
background
PubMed Identifier
25156148
Citation
Hayes MJ, Brown MS. Legalization of medical marijuana and incidence of opioid mortality. JAMA Intern Med. 2014 Oct;174(10):1673-4. doi: 10.1001/jamainternmed.2014.2716. No abstract available.
Results Reference
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PubMed Identifier
29257781
Citation
Heng M, McTague MF, Lucas RC, Harris MB, Vrahas MS, Weaver MJ. Patient Perceptions of the Use of Medical Marijuana in the Treatment of Pain After Musculoskeletal Trauma: A Survey of Patients at 2 Trauma Centers in Massachusetts. J Orthop Trauma. 2018 Jan;32(1):e25-e30. doi: 10.1097/BOT.0000000000001002.
Results Reference
background
PubMed Identifier
28796754
Citation
Khelemsky Y, Goldberg AT, Hurd YL, Winkel G, Ninh A, Qian L, Oprescu A, Ciccone J, Katz DJ. Perioperative Patient Beliefs Regarding Potential Effectiveness of Marijuana (Cannabinoids) for Treatment of Pain: A Prospective Population Survey. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):652-659. doi: 10.1097/AAP.0000000000000654.
Results Reference
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PubMed Identifier
28097606
Citation
Chan MH, Knoepke CE, Cole ML, McKinnon J, Matlock DD. Colorado Medical Students' Attitudes and Beliefs About Marijuana. J Gen Intern Med. 2017 Apr;32(4):458-463. doi: 10.1007/s11606-016-3957-y. Epub 2017 Jan 17.
Results Reference
background
PubMed Identifier
28887020
Citation
Cancienne JM, Patel KJ, Browne JA, Werner BC. Narcotic Use and Total Knee Arthroplasty. J Arthroplasty. 2018 Jan;33(1):113-118. doi: 10.1016/j.arth.2017.08.006. Epub 2017 Aug 17.
Results Reference
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PubMed Identifier
25694266
Citation
Menendez ME, Ring D, Bateman BT. Preoperative Opioid Misuse is Associated With Increased Morbidity and Mortality After Elective Orthopaedic Surgery. Clin Orthop Relat Res. 2015 Jul;473(7):2402-12. doi: 10.1007/s11999-015-4173-5. Epub 2015 Feb 19.
Results Reference
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PubMed Identifier
25911660
Citation
Morris BJ, Mir HR. The opioid epidemic: impact on orthopaedic surgery. J Am Acad Orthop Surg. 2015 May;23(5):267-71. doi: 10.5435/JAAOS-D-14-00163.
Results Reference
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PubMed Identifier
15340387
Citation
Di Marzo V, Bifulco M, De Petrocellis L. The endocannabinoid system and its therapeutic exploitation. Nat Rev Drug Discov. 2004 Sep;3(9):771-84. doi: 10.1038/nrd1495.
Results Reference
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PubMed Identifier
27832442
Citation
Fitzcharles MA, Hauser W. Cannabinoids in the Management of Musculoskeletal or Rheumatic Diseases. Curr Rheumatol Rep. 2016 Dec;18(12):76. doi: 10.1007/s11926-016-0625-5.
Results Reference
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A RCT Comparing Dronabinol to a Placebo for Post-operative Pain in Total Joint Arthroplasty

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