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Osteoarthritis, KneePhase 3dronabinolNCT04298528

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

A Phase 3 study testing Dronabinol in people with Osteoarthritis, Knee, run by Colorado Joint Replacement at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Dronabinol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
460 participants
Where
1 siteUnited States
Study dates
5 Feb 2020to 5 Feb 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Rose Johnson contact

3032602940

roseannjohnson@centura.org

United States1 site, 1 recruiting

  • Colorado Joint Replacement

    Denver, Colorado, 80210

    Roseann Johnson, 303-260-2940, RoseannJohnson@centura.org

    Jason Jennings, MD

    Recruiting

Other trials in United States

About this study

Official title: A Prospective, Randomized, Double Blind Trial Comparing Dronabinol to a Placebo in the Management of Post-operative Pain in Total Joint Arthroplasty

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

Read the 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.

Being tested
Dronabinol, Placebo
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DronabinolDrug

    Also called Marinol

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

  • PlaceboOther

    Also called Lactose

    2 times a day for 30 days after total knee replacement

Study groups in NCT04298528
Study groupRoleWhat they receive
dronabinolExperimentalPatient 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.
Receives: Drug: Dronabinol
placeboPlacebo comparatorPatient 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.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morphine Equivalence

    Morphine Equivalence of pain medication used after a total knee replacement

    Measured: 30 day's post operative

Secondary outcomes (6)

  1. Nausea

    Patients post operative nausea will be collected as none/mild/moderate/severe

    Measured: 30 day's post operative

  2. Defense and Veterans Pain Scale

    Patients will keep a pain log after their joint replacement on a scale of 0 - 10

    Measured: 30 day's post operative

  3. The Pittsburgh Sleep Quality Index

    To monitor sleeping habits

    Measured: 4 weeks and 6 weeks post operative

  4. Knee Society Score

    Patient reported outcome

    Measured: 4 weeks post operative

  5. KOOS-12 Knee Survey

    Patient reported outcome

    Measured: 6 weeks post operative

  6. The Veterans Rand 12-Item Health Survey

    Patient reported outcome

    Measured: 6 weeks post operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2020
  2. Study start5 Feb 2020
  3. Primary completion5 Feb 2024 (estimated)
  4. Study completion5 Feb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
460 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04298528
Sponsor's protocol ID
1554107
Acronym
dronabinol
Status last verified
Jan 2023
First submitted
4 Mar 2020
Last updated
10 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30799266

  • 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.

    PubMed 30794232

  • 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.

    PubMed 30170713

  • 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.

    PubMed 25156148

  • 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.

    PubMed 29257781

  • 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.

    PubMed 28796754

  • 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.

    PubMed 28097606

  • 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.

    PubMed 28887020

  • 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.

    PubMed 25694266

  • 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.

    PubMed 25911660

  • 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.

    PubMed 15340387

  • 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.

    PubMed 27832442

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dronabinol in people with Osteoarthritis, Knee, run by Colorado Joint Replacement at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rose Johnson (3032602940, roseannjohnson@centura.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morphine Equivalence (time frame: 30 day's post operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04298528, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.

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