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Evaluation of Dronabinol For Acute Pain Following Traumatic Injury

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ClinicalTrials.gov Identifier: NCT03928015
Recruitment Status : Not yet recruiting
First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Claire Swartwood, Centura Health

Brief Summary:

Single center, non-blinded, randomized controlled trial. Enrollment is based on ≥90 MME within 24 hours of admission, followed by a 24 hour screening/randomization window and a participation period extending through the acute hospitalization period.

A total of 216 adult patients admitted with a traumatic injury will be randomized 1:1 across 2 study arms: adjunctive dronabinol or systemic analgesics only. Patients randomized to the dronabinol arm should receive their first dose within 12 hours of randomization; patients will also receive PRN as needed systemic analgesics for pain. Except for the analgesia protocol, all other interventions will be equivalent for participants in both arms.

The clinical effects of analgesia treatment arm will be evaluated during the acute hospitalization (hospital admission through discharge or death). The primary efficacy endpoint will be assessed starting at 48 hours after randomization and carried through to discharge.


Condition or disease Intervention/treatment Phase
Traumatic Injury Pain, Acute Drug: Adjunctive dronabinol Drug: Systemic analgesics Phase 2

Detailed Description:

Single center, non-blinded, randomized controlled trial. Enrollment is based on ≥90 MME within 24 hours of admission, followed by a 24 hour screening/randomization window and a participation period extending through the acute hospitalization period.

A total of 216 adult trauma patients will be randomized 1:1 across 2 study arms: adjunctive dronabinol or systemic analgesics only. Patients randomized to the dronabinol arm should receive their first dose within 12 hours of randomization, starting with 5mg BID and adjusting within the range of 2.5mg - 10mg BID. Patients randomized to dronabinol will also receive PRN as needed systemic analgesics for pain. Except for the analgesia protocol, all other interventions are performed in the context of everyday clinical practice, and thus will be equivalent for participants in both arms.

The clinical effects of analgesia treatment arm will be evaluated during the acute hospitalization (hospital admission through discharge or death). The primary efficacy endpoint will be assessed starting at 48 hours after randomization and carried through to discharge.

The primary trial objective is to evaluate the efficacy of adjunctive dronabinol versus no adjunctive dronabinol (systemic analgesics only) on reduction in opioids in adult patients with traumatic injury.

The secondary trial objectives include: evaluation of the efficacy of dronabinol versus no dronabinol (systemic analgesics only) for pain numeric rating scale (NRS) scores, hospital length of stay, complications, and adverse effects associated with analgesia.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open label, randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Single Centre Randomized Controlled Trial To Evaluate Dronabinol For Acute Pain Management In Adults With Traumatic Injury
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arm Intervention/treatment
Experimental: Adjunctive dronabinol
Dronabinol 5mg BID and adjusting within the range of 2.5mg - 10mg BID, as an adjunct to systemic analgesics
Drug: Adjunctive dronabinol
5mg BID and adjusting within the range of 2.5mg - 10mg BID, minimum of 48 hours, as an adjunct to systemic analgesics
Other Name: Marinol

Active Comparator: Systemic analgesics
Systemic analgesics only
Drug: Systemic analgesics
multimodal analgesia including opioid and non-opioid analgesics
Other Name: standard of care




Primary Outcome Measures :
  1. Morphine equivalent use [ Time Frame: Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization) ]
    Change in morphine milligram equivalent (MME) use


Secondary Outcome Measures :
  1. Pain scores [ Time Frame: Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization) ]
    Change in pain numeric rating scale (NRS) score, which is on a scale of 0-10. A value of 0 indications no pain and a value of 10 indicates highest level of pain

  2. Incidence of complications [ Time Frame: Acute hospitalization period ]
    Analgesic complications and other hospital complications

  3. LOS [ Time Frame: Acute hospitalization period ]
    Hospital LOS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 18 years to 65 years old (inclusive)
  2. Index admission for traumatic injury
  3. High initial morphine equivalent use ≥ 90 mg in the first 24 hours from admission
  4. Baseline pain assessed at screening of ≥ 5 on the pain numeric rating score (NRS)
  5. Willing to divulge habitual marijuana usage (yes or no. Yes, habitual/chronic usage; no, recreational, former, or never usage)

Exclusion Criteria:

  1. Patients on a pain management agreement
  2. Patients who are nil per os (NPO) at the time of randomization or are expected to be NPO within the next 48 hours
  3. Patients who have received or are expected to receive neuraxial/locoregional blocks for pain within the next 48 hours
  4. Known allergy or previous hypersensitivity reaction to dronabinol or sesame oil
  5. Patients prescribed dronabinol between arrival and prior to screening/randomization
  6. Pregnancy or breast feeding
  7. Incarceration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928015


Contacts
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Contact: Eva Ernevad 303.765.3703 evakarinernevad@centura.org
Contact: Claire Swartwood, PharmD 720-321-1175 ClaireSwartwood@Centura.Org

Sponsors and Collaborators
Centura Health

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Responsible Party: Claire Swartwood, Pharmacy Residency Program Director, Centura Health
ClinicalTrials.gov Identifier: NCT03928015     History of Changes
Other Study ID Numbers: 1382279
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Claire Swartwood, Centura Health:
marijuana
dronabinol
morphine milligram equivalents
Additional relevant MeSH terms:
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Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Acute Pain
Wounds and Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Dronabinol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists