Traumatic InjuryPhase 2NCT03928015
Evaluation of Dronabinol For Acute Pain Following Traumatic Injury
A Phase 2 study testing Adjunctive dronabinol and Systemic analgesics in people with Traumatic Injury and Pain, Acute, run by CommonSpirit Health at 1 site in United States.
Trial summary
Single center, non-blinded, randomized controlled trial. Enrollment is based on ≥50 MME within 24 hours of admission, followed by a 24 hour screening/randomization window and a participation period extending through the acute hospitalization period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Injury, Pain, Acute
- What is being tested?
- Adjunctive dronabinol and Systemic analgesics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 29 Jun 2021
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 years to 65 years old (inclusive)
- Index admission for traumatic injury
- High initial morphine equivalent use ≥ 50 mg in the first 24 hours from admission
- Willing to divulge habitual marijuana usage (yes or no. Yes, habitual/chronic usage; no, recreational, former, or never usage)
Who cannot join
- Patients on a pain management agreement
- Patients who are nil per os (NPO) at the time of randomization or are expected to be NPO within the next 48 hours
- Patients who have received or are expected to receive neuraxial/locoregional blocks for pain within the next 48 hours
- Known allergy or previous hypersensitivity reaction to dronabinol or sesame oil
- Patients prescribed dronabinol between arrival and prior to screening/randomization
- Pregnancy or breast feeding
- Incarceration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre Randomized Controlled Trial To Evaluate Dronabinol For Acute Pain Management In Adults With Traumatic Injury
Single center, non-blinded, randomized controlled trial. Enrollment is based on ≥50 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 122 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.
Read the detailed description
Single center, non-blinded, randomized controlled trial. Enrollment is based on ≥50 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 122 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.
- Conditions
- Traumatic Injury, Pain, Acute
- Being tested
- Adjunctive dronabinol, Systemic analgesics
- Keywords
- marijuana, dronabinol, morphine milligram equivalents
- Medical subject headings
- Wounds and Injuries, Acute Pain, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjunctive dronabinolDrug
Also called Marinol
5mg BID and adjusting within the range of 2.5mg - 10mg BID, minimum of 48 hours, as an adjunct to systemic analgesics
Systemic analgesicsDrug
Also called standard of care
multimodal analgesia including opioid and non-opioid analgesics
| Study group | Role | What they receive |
|---|---|---|
| Adjunctive dronabinol | Experimental | Dronabinol 5mg BID and adjusting within the range of 2.5mg - 10mg BID, as an adjunct to systemic analgesics Receives: Drug: Adjunctive dronabinol |
| Systemic analgesics | Active comparator | Systemic analgesics only Receives: Drug: Systemic analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine equivalent use
Change in morphine milligram equivalent (MME) use
Measured: Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization)
Secondary outcomes (3)
Pain scores
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
Measured: Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization)
Incidence of complications
Analgesic complications and other hospital complications
Measured: Acute hospitalization period
LOS
Hospital LOS
Measured: Acute hospitalization period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start1 Oct 2019
- Primary completion29 Jun 2021
- Study completion29 Jun 2021
Why it stopped: This trial did not enroll subjects. After initial approval we procured an appropriate placebo. Before IRB the amendment was approved, the COVID-19 pandemic placed a hold on all non-essential research activity at the enrolling hospital.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CommonSpirit Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire Swartwood, CommonSpirit Health
- Investigators
- Claire J Swartwood, PharmD, Principal investigator, Centura Health - St. Anthony Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928015
- Sponsor's protocol ID
- 1382279
- Status last verified
- Jul 2022
- First submitted
- 9 Apr 2019
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Swartwood C, Salottolo K, Madayag R, Bar-Or D. Efficacy of Dronabinol for Acute Pain Management in Adults with Traumatic Injury: Study Protocol of A Randomized Controlled Trial. Brain Sci. 2020 Mar 12;10(3):161. doi: 10.3390/brainsci10030161.
PubMed 32178232
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre Randomized Controlled Trial To Evaluate Dronabinol For Acute Pain Management In Adults With Traumatic Injury
- ClinicalTrials.gov ID
- NCT03928015
- Acronym / sponsor ID
- 1382279
- Conditions
- Traumatic Injury, Pain, Acute
- Keywords
- marijuana, dronabinol, morphine milligram equivalents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This trial did not enroll subjects. After initial approval we procured an appropriate placebo. Before IRB the amendment was approved, the COVID-19 pandemic placed a hold on all non-essential research activity at the enrolling hospital.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CommonSpirit HealthUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single center, non-blinded, randomized controlled trial. Enrollment is based on ≥50 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 122 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.
Detailed description
Single center, non-blinded, randomized controlled trial. Enrollment is based on ≥50 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 122 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Adjunctive dronabinol | Experimental | Drug: Adjunctive dronabinolDronabinol 5mg BID and adjusting within the range of 2.5mg - 10mg BID, as an adjunct to systemic analgesics |
| Systemic analgesics | Active comparator | Drug: Systemic analgesicsSystemic analgesics only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, 18 years to 65 years old (inclusive)
- Index admission for traumatic injury
- High initial morphine equivalent use ≥ 50 mg in the first 24 hours from admission
- Willing to divulge habitual marijuana usage (yes or no. Yes, habitual/chronic usage; no, recreational, former, or never usage)
Key exclusion criteria (7 listed)
- Patients on a pain management agreement
- Patients who are nil per os (NPO) at the time of randomization or are expected to be NPO within the next 48 hours
- Patients who have received or are expected to receive neuraxial/locoregional blocks for pain within the next 48 hours
- Known allergy or previous hypersensitivity reaction to dronabinol or sesame oil
- Patients prescribed dronabinol between arrival and prior to screening/randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjunctive dronabinolAlso: Marinol5mg BID and adjusting within the range of 2.5mg - 10mg BID, minimum of 48 hours, as an adjunct to systemic analgesics | Drug | Adjunctive dronabinol |
| Systemic analgesicsAlso: standard of caremultimodal analgesia including opioid and non-opioid analgesics | Drug | Systemic analgesics |
Primary outcome
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
3 secondary outcomes
Pain scores
Time frame: Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization)
Incidence of complications
Time frame: Acute hospitalization period
LOS
Time frame: Acute hospitalization period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Derived from this study: PubMed 32178232Swartwood C, Salottolo K, Madayag R, Bar-Or D. Efficacy of Dronabinol for Acute Pain Management in Adults with Traumatic Injury: Study Protocol of A Randomized Controlled Trial. Brain Sci. 2020 Mar 12;10(3):161. doi: 10.3390/brainsci10030161.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire J Swartwood, PharmD principal investigator
Centura Health - St. Anthony Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adjunctive dronabinol and Systemic analgesics in people with Traumatic Injury and Pain, Acute, run by CommonSpirit 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 7 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 Jul 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Morphine equivalent use (time frame: Post-randomization (48 hours after randomization) - pre-randomization (24 hours prior to randomization)). 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 NCT03928015, which also lists 1 linked publication.
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 Jul 2022.