FracturePhase 2CAM-POTNCT06448923
Cannabidiol After Multi-Trauma for Pain and Opioid Therapy
A Phase 2 study testing Cannabidiol in people with Fracture, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial summary
The aim of this project is to investigate the therapeutic potential and safety of acute Cannabidiol (CBD) treatment on longitudinal pain symptoms, and to assess potential interactions with pain mediators including opioids and sex on CBD treatment response. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fracture
- What is being tested?
- Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2025to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a long bone fracture of the lower limb (tibia, fibula, femur, metatarsals, and phalanges) or the upper limb (humerus, radius, ulna, metacarpals, and phalanges) treated to Sacre-Coeur Hospital in Montreal (HSCM) within one week of the accident
- Participants is between 18 and 70 years of age
- Patients with or without surgical procedures
Who cannot join
- Moderate/severe traumatic brain injury (TBI)
- Diagnosis of any of the following mental disorders as defined by the DSM-5: schizophrenia, intellectual disability, bipolar disorder, major depression, a diagnosed and untreated sleep disorders
- History of alcohol or opioid misuse/abuse, as defined by the DSM-5
- Evidence of severe renal (stage 4 or 5) or hepatic impairment (Child B or C)
- Pregnant or lactating women, women of childbearing potential who are not using medically accepted forms of contraception (e.g., condoms, oral contraceptive or intrauterine device), or women who are actively planning on becoming pregnant
- History of adverse reactions to cannabis
Show all 13Show fewer
- Patients taking warfarin, sildenafil, valproate or under opioids treatment prior to the injury
- Patients experiencing on average mild-to-absent pain in the last 24h preceding recruitment (as per a score <30 on a 0-100mm Visual Analogue Scale (VAS))
- Transport business drivers and heavy machinery operators
- A diagnosis of chronic pain, bone pathology (e.g., osteoporosis) or chronic inflammatory disease (e.g., rheumatoid arthritis, arthritis, psoriasis)
- Not having French or English as a spoken language
- A weighted MoCA score of less than 24
- Regular cannabis use more than 5 times a week
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hôpital Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5
Amélie Apinis-Deshaies Research Coordinator, 514-338-2222 ext. 5833265, amelie.apinis-deshaies.cnmtl@ssss.gouv.qc.ca
About this study
Official title: Effects of an Acute 1-month Cannabidiol Treatment on Pain and Inflammation After a Long Bone Fracture: a Triple-blind Randomized, Placebo Controlled Clinical Trial
The aim of this project is to investigate the therapeutic potential and safety of acute Cannabidiol (CBD) treatment on longitudinal pain symptoms, and to assess potential interactions with pain mediators including opioids and sex on CBD treatment response. To this end, this research protocol proposes a comprehensive translational approach including a placebo-controlled randomized clinical trial comparing two daily doses of CBD treatment administered for one month on pain relief. This study will also compare intervention conditions on inflammation markers, participant quality of life, sleep quality, depression, anxiety, cognition and orthopaedic function.
Read the detailed description
The level of pain in the acute phase after injury is a predictor of the development of chronic pain. Chronic pain is defined as pain that persists for more than 3 months post-accident and impairs functional recovery. Mechanistically, it has been shown that acute nonspecific inflammation triggered after peripheral injury results in the continuous release of proinflammatory cytokines that weaken the blood-brain barrier, facilitating the entry of toxins that can invade the central nervous system (CNS). The resulting sustained inflammation of the CNS plays an important role in establishing the maladaptive plasticity process underlying pain chronification. Cannabidiol (CBD), a component of cannabis devoid of addictive or psychotropic effects, stands out as a potential therapeutic agent given its analgesic and anti-inflammatory properties as well as its potential to enhance the biomechanical properties of bone healing. Given the excellent safety profile of CBD and its inhibitory effects on microglial activity, the primary mechanism of neuroinflammation and pain, CBD has the potential to promote acute pain relief while reducing reliance on addictive opioid treatments, hence facilitating recovery in trauma patients.
This study is a randomized, placebo controlled, human pilot clinical trial evaluating the effects of two doses (low and moderate) of CBD vs. placebo on pain after orthopaedic trauma.
Risks of adverse effects are considered low given the demonstrated excellent safety profile of CBD. CBD was also shown to accentuate opioid analgesic effects, thus reducing required opioid doses for patient comfort. The most likely adverse events associated with CBD in adult patients include somnolence, fatigue, drowsiness and decreased appetite. Access to on-duty emergency physicians at the recruiting site will be provided during the entire treatment duration.
A 30% relative pain intensity reduction on the VAS (expected response of 50% or more in the CBD group and expected 20% in the placebo group) has been used extensively to reflect clinically significant pain relief in clinical trials. Based on a Fisher's exact test, a sample size of 225 participants (3 groups of 75) will be required to reach a power of 80% to detect a statistically significant difference in the proportion of patients who reaches 30% pain reduction between the CBD groups and placebo at 1-month post-injury, assuming a dropout rate of 20% and a significance level of 5%. These parameters are taken from a successful randomised, placebo-controlled clinical trial using Sativex© in treating 125 neuropathic pain patients. Moreover, considering that the placebo group may ingest more opiates and that the anticipated inter-group effect at one month may be reduced to 20%, a total sample size of 225 subjects could be required to achieve 80% power, assuming a drop-out rate of 20% and a significance level of 5%.
Our group has ensured the feasibility of conducting such a pilot clinical trial in multi-trauma patients with the recruitment of 110 patients in less than 18 months to take part in a 10-session, outpatient treatment trial. A partnership with Canadian company EmpowerPharm will enable the use of pharmaceutical-grade synthetic CBD samples and identical placebos. The pharmacokinetic profile of the CBD product has been established.
- Conditions
- Fracture
- Being tested
- Cannabidiol, Placebo
- Keywords
- Cannabidiol, Trauma, Pain, Inflammation, Fracture, Orthopaedic
- Medical subject headings
- Fractures, Bone, Wounds and Injuries, Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
25 mg of CBD tablets twice daily
CannabidiolDrug
50 mg of CBD tablets twice daily
PlaceboDrug
Matching placebo tablets twice daily
| Study group | Role | What they receive |
|---|---|---|
| Low CBD dose | Experimental | Participants will receive 25 mg orally twice daily during a meal for a month Receives: Drug: Cannabidiol |
| Moderate CBD dose | Experimental | Participants will receive 50 mg orally twice daily during a meal for a month Receives: Drug: Cannabidiol |
| Placebo | Placebo comparator | Participants will receive matching placebo orally twice daily during a meal for a month Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline on Pain Intensity Rating on a Visual Analog Scale (VAS) at Week 4
VAS pain intensity will be collected at baseline (before the start of treatment), twice a week during treatment, 24 hours after the end of treatment and at the 3-month follow-up. The VAS is a 100 mm line with anchor words ranging from "no pain" to "worst pain imaginable". Participants will be asked to place an intersecting mark along the line to indicate their pain intensity at the specific time of the test.
Measured: Baseline and 4 weeks
Secondary outcomes (16)
Response Rate - 50 Percent or Greater Reduction in Pain Intensity on a Visual Analog Scale (VAS)
The response rate was defined as the number of participants with a 50 percent or greater reduction in VAS pain score from baseline to end of treatment. The VAS is a 100 mm line with anchor words ranging from "no pain" to "worst pain imaginable".
Measured: 4 weeks
Change in Pain Rating on the Brief Pain Inventory Short Form (BPI-sf) Between Interventions
The Brief Pain Inventory short form (BPI-sf) is a 9-item self-reported questionnaire assessing for the presence, intensity, and location(s) of pain, as well as perceived efficacy of pain relief treatment, and pain interference with activities of daily living. Item scores range from 0-10. The lower the score, the better the subject's pain.
Measured: 4 weeks and 3 months
Change in Blood Level Inflammation Over Time and Between Interventions
Blood levels of pro-inflammatory cytokines including interleukins (IL-6, IL-10) and tumor necrosis factor-alpha (TNF-α) will be collected and quantified.
Measured: Baseline, 4 weeks and 3 months
Opioid Usage Monitoring
Opioid usage will be collected from daily medication diary for the first month and from number of prescription refills for months 2 and 3.
Measured: Ongoing from baseline to 3 months
Change in the Orthopaedic Function Using The Short Musculoskeletal Function Assessment (SMFA) Questionnaire Between Interventions
The SMFA consists of 34 questions covering the assessment of the patients function and 12 questions related to how bothered patients are by their symptoms. All categories are scored together, totaling between 0-100 percent. The lower the score, the better the subject's function.
Measured: 4 weeks and 3 months
Change in Quality of Life Using the Short Form (36) Health Survey Between Interventions
The SF-36 is a 36-item self-report questionnaire for measuring quality of life across 9 domains. Scores range from 0-100, the lower the score, the worse is the subject's quality of life.
Measured: 4 weeks and 3 months
Change in Sleep Quality Using the Pittsburgh Sleep Quality Index (PSQI) Between Interventions
A self-report questionnaire that assesses sleep quality and quantity during the past 4 weeks. The PSQI contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).
Measured: 4 weeks and 3 months
Change in Depression Symptoms Assessment Using the Beck's Depression Inventory-II Between Interventions
A 21-item multiple-choice self-report questionnaire for measuring depression symptoms. Scores range from 0 to 63, with higher scores representing more severe symptoms of depression.
Measured: Baseline, 4 weeks and 3 months
Change in Anxiety Symptoms Assessment Using the Beck's Anxiety Inventory Between Interventions
A 21-question multiple-choice self-report inventory used for measuring the severity of anxiety symptoms. Score range from 0 to 63. Higher scores indicate more severe anxiety symptoms.
Measured: Baseline, 4 weeks and 3 months
Change in Speed of Information Processing using Symbol Search from the WAIS-IV Battery Between Intervention
A neuropsychological test highly sensitive to both mild traumatic brain injury (mTBI) and pain and which do not require the use of injured limbs will be administered. Symbol Search from the WAIS-IV Battery, a tasks assessing speed of information processing, will be administered. Scaled Score range from 0 to 19. Higher scores indicate better processing speed.
Measured: Baseline, 4 weeks and 3 months
Change in Attention using Elevator counting with distraction from the Test of Everyday Attention Battery Between Intervention
A neuropsychological test highly sensitive to both mild traumatic brain injury (mTBI) and pain and which do not require the use of injured limbs will be administered. Elevator counting with distraction from the Test of Everyday Attention Battery, a tasks assessing attention, will be administered. Scaled Score range from 0 to 19. Higher scores indicate better attention.
Measured: Baseline, 4 weeks and 3 months
Change in Attention using Elevator counting from the Test of Everyday Attention Battery Between Intervention
A neuropsychological test highly sensitive to both mild traumatic brain injury (mTBI) and pain and which do not require the use of injured limbs will be administered. Elevator counting from the Test of Everyday Attention Battery, a tasks assessing attention, will be administered. Scaled Score range from 0 to 19. Higher scores indicate better attention.
Measured: Baseline, 4 weeks and 3 months
Change in Memory using the California Verbal Learning Test Between Interventions
A neuropsychological test highly sensitive to both mild traumatic brain injury (mTBI) and pain and which do not require the use of injured limbs will be administered. The California Verbal Learning Test, a tasks assessing memory, will be administered. Standard Score range from -5 to 5. Higher scores indicate better memory.
Measured: Baseline, 4 weeks and 3 months
Change in Memory using Digit Span from the WAIS-IV Battery Between Intervention
A neuropsychological test highly sensitive to both mild traumatic brain injury (mTBI) and pain and which do not require the use of injured limbs will be administered. Digit Span from the WAIS-IV Battery, a tasks assessing memory, will be administered. Scaled Score range from 0 to 19. Higher scores indicate better memory.
Measured: Baseline, 4 weeks and 3 months
Change in Executive Fonction using the D-KEFS Color-Word Between Interventions
A neuropsychological test highly sensitive to both mild traumatic brain injury (mTBI) and pain and which do not require the use of injured limbs will be administered. The D-KEFS Color-Word, a tasks assessing executive function, will be administered. Scaled Score range from 1 to 19. Higher scores indicate better executive function.
Measured: Baseline, 4 weeks and 3 months
Change in Executive Function using the D-KEFS Verbal Fluency Between Interventions
A neuropsychological test highly sensitive to both mild traumatic brain injury (mTBI) and pain and which do not require the use of injured limbs will be administered. The D-KEFS Verbal Fluency, a tasks assessing executive function, will be administered. Scaled Score range from 1 to 19. Higher scores indicate better executive function.
Measured: Baseline, 4 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
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 FractureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis De Beaumont, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448923
- Sponsor's protocol ID
- 2025-2105
- Acronym
- CAM-POT
- Status last verified
- Jul 2025
- First submitted
- 28 May 2024
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brazeau D, Deshaies AA, Williamson D, Bernard F, Arbour C, Pinard AM, Rouleau D, De Beaumont L. Impact of an acute 1-month cannabidiol treatment on pain and inflammation after a long bone fracture: a triple-blind randomised, placebo-controlled, clinical trial protocol. BMJ Open. 2025 Feb 20;15(2):e092919. doi: 10.1136/bmjopen-2024-092919.
PubMed 39979051
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Acute 1-month Cannabidiol Treatment on Pain and Inflammation After a Long Bone Fracture: a Triple-blind Randomized, Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06448923
- Acronym / sponsor ID
- CAM-POT / 2025-2105
- Conditions
- Fracture
- Keywords
- Cannabidiol, Trauma, Pain, Inflammation, Fracture, Orthopaedic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 7 Jun 2024 (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.
The aim of this project is to investigate the therapeutic potential and safety of acute Cannabidiol (CBD) treatment on longitudinal pain symptoms, and to assess potential interactions with pain mediators including opioids and sex on CBD treatment response. To this end, this research protocol proposes a comprehensive translational approach including a placebo-controlled randomized clinical trial comparing two daily doses of CBD treatment administered for one month on pain relief. This study will also compare intervention conditions on inflammation markers, participant quality of life, sleep quality, depression, anxiety, cognition and orthopaedic function.
Detailed description
The level of pain in the acute phase after injury is a predictor of the development of chronic pain. Chronic pain is defined as pain that persists for more than 3 months post-accident and impairs functional recovery. Mechanistically, it has been shown that acute nonspecific inflammation triggered after peripheral injury results in the continuous release of proinflammatory cytokines that weaken the blood-brain barrier, facilitating the entry of toxins that can invade the central nervous system (CNS). The resulting sustained inflammation of the CNS plays an important role in establishing the maladaptive plasticity process underlying pain chronification. Cannabidiol (CBD), a component of cannabis devoid of addictive or psychotropic effects, stands out as a potential therapeutic agent given its analgesic and anti-inflammatory properties as well as its potential to enhance the biomechanical properties of bone healing. Given the excellent safety profile of CBD and its inhibitory effects on microglial activity, the primary mechanism of neuroinflammation and pain, CBD has the potential to promote acute pain relief while reducing reliance on addictive opioid treatments, hence facilitating recovery in trauma patients.
This study is a randomized, placebo controlled, human pilot clinical trial evaluating the effects of two doses (low and moderate) of CBD vs. placebo on pain after orthopaedic trauma.
Risks of adverse effects are considered low given the demonstrated excellent safety profile of CBD. CBD was also shown to accentuate opioid analgesic effects, thus reducing required opioid doses for patient comfort. The most likely adverse events associated with CBD in adult patients include somnolence, fatigue, drowsiness and decreased appetite. Access to on-duty emergency physicians at the recruiting site will be provided during the entire treatment duration.
A 30% relative pain intensity reduction on the VAS (expected response of 50% or more in the CBD group and expected 20% in the placebo group) has been used extensively to reflect clinically significant pain relief in clinical trials. Based on a Fisher's exact test, a sample size of 225 participants (3 groups of 75) will be required to reach a power of 80% to detect a statistically significant difference in the proportion of patients who reaches 30% pain reduction between the CBD groups and placebo at 1-month post-injury, assuming a dropout rate of 20% and a significance level of 5%. These parameters are taken from a successful randomised, placebo-controlled clinical trial using Sativex© in treating 125 neuropathic pain patients. Moreover, considering that the placebo group may ingest more opiates and that the anticipated inter-group effect at one month may be reduced to 20%, a total sample size of 225 subjects could be required to achieve 80% power, assuming a drop-out rate of 20% and a significance level of 5%.
Our group has ensured the feasibility of conducting such a pilot clinical trial in multi-trauma patients with the recruitment of 110 patients in less than 18 months to take part in a 10-session, outpatient treatment trial. A partnership with Canadian company EmpowerPharm will enable the use of pharmaceutical-grade synthetic CBD samples and identical placebos. The pharmacokinetic profile of the CBD product has been established.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low CBD dose | Experimental | Drug: CannabidiolParticipants will receive 25 mg orally twice daily during a meal for a month |
| Moderate CBD dose | Experimental | Drug: CannabidiolParticipants will receive 50 mg orally twice daily during a meal for a month |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo orally twice daily during a meal for a month |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a long bone fracture of the lower limb (tibia, fibula, femur, metatarsals, and phalanges) or the upper limb (humerus, radius, ulna, metacarpals, and phalanges) treated to Sacre-Coeur Hospital in Montreal (HSCM) within one week of the accident
- Participants is between 18 and 70 years of age
- Patients with or without surgical procedures
Key exclusion criteria (13 listed)
- Moderate/severe traumatic brain injury (TBI)
- Diagnosis of any of the following mental disorders as defined by the DSM-5: schizophrenia, intellectual disability, bipolar disorder, major depression, a diagnosed and untreated sleep disorders
- History of alcohol or opioid misuse/abuse, as defined by the DSM-5
- Evidence of severe renal (stage 4 or 5) or hepatic impairment (Child B or C)
- Pregnant or lactating women, women of childbearing potential who are not using medically accepted forms of contraception (e.g., condoms, oral contraceptive or intrauterine device), or women who are actively planning on becoming pregnant
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 |
|---|---|---|
| Cannabidiol25 mg of CBD tablets twice daily | Drug | Low CBD dose |
| Cannabidiol50 mg of CBD tablets twice daily | Drug | Moderate CBD dose |
| PlaceboMatching placebo tablets twice daily | Drug | Placebo |
Primary outcome
Change From Baseline on Pain Intensity Rating on a Visual Analog Scale (VAS) at Week 4
Time frame: Baseline and 4 weeks
VAS pain intensity will be collected at baseline (before the start of treatment), twice a week during treatment, 24 hours after the end of treatment and at the 3-month follow-up. The VAS is a 100 mm line with anchor words ranging from "no pain" to "worst pain imaginable". Participants will be asked to place an intersecting mark along the line to indicate their pain intensity at the specific time of the test.
16 secondary outcomes
Response Rate - 50 Percent or Greater Reduction in Pain Intensity on a Visual Analog Scale (VAS)
Time frame: 4 weeks
Change in Pain Rating on the Brief Pain Inventory Short Form (BPI-sf) Between Interventions
Time frame: 4 weeks and 3 months
Change in Blood Level Inflammation Over Time and Between Interventions
Time frame: Baseline, 4 weeks and 3 months
Opioid Usage Monitoring
Time frame: Ongoing from baseline to 3 months
Change in the Orthopaedic Function Using The Short Musculoskeletal Function Assessment (SMFA) Questionnaire Between Interventions
Time frame: 4 weeks and 3 months
Change in Quality of Life Using the Short Form (36) Health Survey Between Interventions
Time frame: 4 weeks and 3 months
Change in Sleep Quality Using the Pittsburgh Sleep Quality Index (PSQI) Between Interventions
Time frame: 4 weeks and 3 months
Change in Depression Symptoms Assessment Using the Beck's Depression Inventory-II Between Interventions
Time frame: Baseline, 4 weeks and 3 months
Change in Anxiety Symptoms Assessment Using the Beck's Anxiety Inventory Between Interventions
Time frame: Baseline, 4 weeks and 3 months
Change in Speed of Information Processing using Symbol Search from the WAIS-IV Battery Between Intervention
Time frame: Baseline, 4 weeks and 3 months
Change in Attention using Elevator counting with distraction from the Test of Everyday Attention Battery Between Intervention
Time frame: Baseline, 4 weeks and 3 months
Change in Attention using Elevator counting from the Test of Everyday Attention Battery Between Intervention
Time frame: Baseline, 4 weeks and 3 months
Change in Memory using the California Verbal Learning Test Between Interventions
Time frame: Baseline, 4 weeks and 3 months
Change in Memory using Digit Span from the WAIS-IV Battery Between Intervention
Time frame: Baseline, 4 weeks and 3 months
Change in Executive Fonction using the D-KEFS Color-Word Between Interventions
Time frame: Baseline, 4 weeks and 3 months
Change in Executive Function using the D-KEFS Verbal Fluency Between Interventions
Time frame: Baseline, 4 weeks and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Derived from this study: PubMed 39979051Brazeau D, Deshaies AA, Williamson D, Bernard F, Arbour C, Pinard AM, Rouleau D, De Beaumont L. Impact of an acute 1-month cannabidiol treatment on pain and inflammation after a long bone fracture: a triple-blind randomised, placebo-controlled, clinical trial protocol. BMJ Open. 2025 Feb 20;15(2):e092919. doi: 10.1136/bmjopen-2024-092919.
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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.
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 Cannabidiol in people with Fracture, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
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 3 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 30 Jul 2025. 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 Canada. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louis De Beaumont, PhD (514-338-2222 ext. 5833263, louis.de.beaumont@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline on Pain Intensity Rating on a Visual Analog Scale (VAS) at Week 4 (time frame: Baseline and 4 weeks). 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 NCT06448923, 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 30 Jul 2025.