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

NCT04298528 | Unknown Phase 3 FDA Drug

• 1 other identifier: 1554107
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study was to determine if cannabinoid use decreases narcotic consumption in patients undergoing total knee arthroplasty (TKA).

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Morphine Equivalence

  Morphine Equivalence of pain medication used after a total knee replacement

  30 day's post operative

Secondary Outcomes (6)

• Nausea

  30 day's post operative

• Defense and Veterans Pain Scale

  30 day's post operative

• The Pittsburgh Sleep Quality Index

  4 weeks and 6 weeks post operative

• Knee Society Score

  4 weeks post operative

• KOOS-12 Knee Survey

  6 weeks post operative

Study Arms (2)

dronabinol

EXPERIMENTAL

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.

Drug: Dronabinol

placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Dronabinol DRUG

2.5mg 2 times a day for 30 days after total knee replacement

Also known as: Marinol

dronabinol

Placebo OTHER

2 times a day for 30 days after total knee replacement

Also known as: Lactose

placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Colorado Joint Replacement: lead

Study Sites (1)

Colorado Joint Replacement

Denver, Colorado, 80210, United States

RECRUITING

Related Publications (12)

• 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.

  PMID: 30799266 BACKGROUND

• 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.

  PMID: 30794232 BACKGROUND

• 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.

  PMID: 30170713 BACKGROUND

• 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.

  PMID: 25156148 BACKGROUND

• 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.

  PMID: 29257781 BACKGROUND

• 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.

  PMID: 28796754 BACKGROUND

• 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.

  PMID: 28097606 BACKGROUND

• 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.

  PMID: 28887020 BACKGROUND

• 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.

  PMID: 25694266 BACKGROUND

• 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.

  PMID: 25911660 BACKGROUND

• 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.

  PMID: 15340387 BACKGROUND

• 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.

  PMID: 27832442 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Dronabinol; Lactose

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Jason M Jennings, MD DPT

  Colorado Joint Replacement

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rose Johnson

CONTACT

3032602940; roseannjohnson@centura.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 6, 2020
• Study Start: February 5, 2020
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2025
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)