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Ankle FracturesPhase 4NCT04768478

CBD for Pain Reduction and Opioid Use After Ankle and Tibia Fracture ORIF

A Phase 4 study testing CBD in people with Ankle Fractures and Tibia Fracture, run by NYU Langone Health at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate the effects of administering CBD to control post-operative pain in patients undergoing ankle fracture open reduction and internal fixation, tibial plafond (pilon) open reduction and internal fixation, tibial shaft repair (open reduction internal fixation or intramedullary nail… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ankle Fractures, Tibia Fracture
What is being tested?
CBD
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Oct 2021to 31 Dec 2023
Phase
Phase 4
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients undergoing an ankle fracture open reduction and internal fixation (medial malleolus, lateral malleolus, posterior malleolus, and/or syndesmosis repair), tibial plafond (pilon) open reduction and internal fixation, tibial shaft repair (open reduction internal fixation and intramedullary nail fixation), or tibial plateau open reduction and internal fixation
  • Patients ages 18-75, inclusive
  • Female patients must be currently practicing effective forms of two types of birth control, which are defined as those, alone or in combination, that result in a low failure rate (less than 1% per year) when used consistently and correctly
  • Male patients must be using an effective form of contraception

Who cannot join

  • Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
  • Younger than 18 years of age
  • Older than 75 years of age
  • Any patient considered a vulnerable subject: pregnant women or fetuses, children, cognitively impaired adults, prisoners
  • History of cannabis abuse or dependence
  • History of coagulation abnormalities and thromboembolic disease or current abnormal coagulation test values
Show all 21Show fewer
  • History of stroke or acute coronary syndromes within 3 months before surgery
  • Abnormal coagulation profile
  • Renal failure (serum creatinine > 250 μmol/L [2.83 mg/dL]) or liver cirrhosis
  • Patients that have been on pre-operative opioid management for any reason
  • Patients meeting the DSM-V for major psychiatric illness, such as bipolar disorder
  • Patients diagnosed with major depression, psychosis, or substance abuse disorder
  • Patients with current or a history of suicidal ideation
  • Breastfeeding females
  • Patients with clinically significant illness, including cardiovascular disorders
  • Clinically significant lab abnormalities
  • Abnormal LFTs
  • Patients with major neurological disorders, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain/head injury, or seizures
  • Patients with moderate (Child-Pugh B) and severe hepatic impairment (Child-Pugh C).
  • Patients taking moderate or strong inhibitors of CYP3A4 and CYP2C19 concomitantly
  • Patients taking strong CYP3A4 and CYP2C19 inducers concomitantly

Trial locations and contacts

1 site in 1 country.

United States1 site

  • NYU Langone Orthopedic Hospital

    New York, New York, 10010

Other trials in United States

About this study

Official title: The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Ankle and Tibia Fracture Open Reduction and Internal Fixation. A Double-Blind, Randomized Control Study

The purpose of this study is to evaluate the effects of administering CBD to control post-operative pain in patients undergoing ankle fracture open reduction and internal fixation, tibial plafond (pilon) open reduction and internal fixation, tibial shaft repair (open reduction internal fixation or intramedullary nail fixation), or tibial plateau open reduction and internal fixation. Secondly, the purpose is to evaluate the effectiveness of CBD in comparison with opioid therapy for post-operative pain.

Being tested
CBD, Placebo
Keywords
Cannabidiol
Medical subject headings
Ankle Fractures, Tibial Fractures

What participants receive

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

  • CBDDrug

    25mg CBD ODTs (orally disintegrating tablet), with instructions to take CBD tablets t.i.d. (total of 50mg per dose t.i.d.) to be administered with routine post-operative pain management

  • PlaceboDrug

    Visually indistinguishable placebo ODTs, with instructions to take two tablets t.i.d., to be administered with routine post-operative pain management

Study groups in NCT04768478
Study groupRoleWhat they receive
Cannabidiol (CBD)Active comparatorNot described
Receives: Drug: CBD
ControlPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Score on Pain Visual Analog Scale (VAS)

    Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; total range = 0-10; 0 = no pain, 10 = worst pain imaginable)

    Measured: Day 2 Post-Surgery

  2. Score on Pain Visual Analog Scale (VAS)

    Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; total range = 0-10; 0 = no pain, 10 = worst pain imaginable)

    Measured: Day 7 Post-Surgery

  3. Score on Pain Visual Analog Scale (VAS)

    Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; total range = 0-10; 0 = no pain, 10 = worst pain imaginable)

    Measured: Day 14 Post-Surgery

  4. Level of Nausea Using VAS

    Any nausea experienced by the patients will be recorded by use of a VAS (total range = 0-10; 0 = no nausea, 10 = worst nausea imaginable)

    Measured: Day 2 Post-Surgery

  5. Level of Nausea Using VAS

    Any nausea experienced by the patients will be recorded by use of a VAS (total range = 0-10; 0 = no nausea, 10 = worst nausea imaginable)

    Measured: Day 7 Post-Surgery

  6. Level of Nausea Using VAS

    Any nausea experienced by the patients will be recorded by use of a VAS (total range = 0-10; 0 = no nausea, 10 = worst nausea imaginable)

    Measured: Day 14 Post-Surgery

Secondary outcomes (7)

  1. CBD Consumption

    Patient self report

    Measured: Day 2 Post-Surgery

  2. CBD Consumption

    Patient self report

    Measured: Day 7 Post-Surgery

  3. CBD Consumption

    Patient self report

    Measured: Day 14 Post-Surgery

  4. Opioid Consumption

    Patient self report

    Measured: Day 2 Post-Surgery

  5. Opioid Consumption

    Patient self report

    Measured: Day 7 Post-Surgery

  6. Opioid Consumption

    Patient self report

    Measured: Day 14 Post-Surgery

  7. Patient Satisfaction Score

    Patients will record their satisfaction with their management, on a 0-10 scale. The higher the score, the higher the satisfaction.

    Measured: Day 14 Post-Surgery

Timeline

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

  1. First posted24 Feb 2021
  2. Study start1 Oct 2021 (estimated)
  3. Primary completion1 Oct 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Why it stopped: there was no funding to begin the study

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04768478
Sponsor's protocol ID
21-00069
Status last verified
Jan 2022
First submitted
22 Feb 2021
Last updated
28 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing CBD in people with Ankle Fractures and Tibia Fracture, run by NYU Langone Health 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 4 inclusion and 21 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: withdrawn, as of the sponsor's last update on 28 Jan 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score on Pain Visual Analog Scale (VAS) (time frame: Day 2 Post-Surgery). The study lists 6 primary outcomes in all. 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 NCT04768478.

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 28 Jan 2022.

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