Spinal SurgeryPhase 4PROMISENCT06843174
Perioperative Rectal Methadone in Spine Surgery
A Phase 4 study testing Rectal Methadone administer during spinal surgery in people with Spinal Surgery and Post-operative Care, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Patients undergoing spinal surgery require pain control medication after their surgery. Investigators have successfully used intravenous Methadone to manage pain after surgery. However, doctors in Canada do not have the intravenous form of Methadone to prescribe to their patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Surgery, Post-operative Care, Post-operative Pain Management
- What is being tested?
- Rectal Methadone administer during spinal surgery
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 19 Feb 2025to Mar 2027
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older
- Elective spinal surgery with fusion of one or more sacral, lumbar, thoracic, and/or cervical levels
- Capacity to provide informed consent
- For participants of childbearing potential, use of contraception.
Who cannot join
- American Society of Anesthesiologists Physical Status > IV
- Hypersensitivity to the active substance (methadone hydrochloride) or other opioid analgesics or to any ingredient in the formulation
- Pregnant or nursing participants
- Known or suspected mechanical gastrointestinal obstruction
- Acute respiratory depression, elevated carbon dioxide levels in the blood, cor pulmonale, or pulmonary disease necessitating home oxygen therapy
- Acute alcohol intoxication, delirium tremens, and convulsive disorders secondary to alcohol intoxication
Show all 16Show fewer
- Severe central nervous system depression, increased intracranial pressure, or head injury
- Use of monoamine oxidase (MAO) inhibitors, such as isocarboxazid, phenelzine, selegiline, and tranylcypromine, within 14 days of enrollment
- Diarrhea associated with pseudomembranous colitis caused by cephalosporins, lincomycins, or penicillins
- Preoperative renal insufficiency or failure
- Significant liver disease (cirrhosis or hepatic failure)
- History of opioid use disorder within the last 3 months
- Patients taking more than 90 mg of morphine equivalents daily
- Poor comprehension of the English language
- Patients who are likely to remain intubated postoperatively
- QT interval > 500ms on preoperative ECG
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Janneth A Pazmino-Canizares, MSc contact
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Sergio Pereira, MD. PhD, 416-360-4000 ext. 49803, sergio.pereira@unityhealth.to
Janneth Pazmino-Canizares, MSc, 4168646060 ext. 49561, Janneth.Pazmino-Canizares@unityhealth.to
About this study
Patients undergoing spinal surgery require pain control medication after their surgery. Investigators have successfully used intravenous Methadone to manage pain after surgery. However, doctors in Canada do not have the intravenous form of Methadone to prescribe to their patients. The investigators in Canada propose a pilot trial to investigate whether Methadone administered rectally could be used to manage pain after spinal surgery.
The main questions are:
Read more
- Are investigators able to recruit participants for this trial and learn from this study to plan a larger trial?
- Does Methadone administered rectally during surgery, reduce participants' pain intensity, use less pain medication, and have a better recovery after surgery? Investigators will compare Methadone to a placebo (a look-alike substance that contains no drug) to see if Methadone works to manage pain after surgery better than the usual pain management.
Participants will:
- receive either Methadone or placebo during surgery.
- be asked some questions about their pain during days 1 to 3 after surgery
- be contacted by phone to ask about their recovery
At this time, the study aims to recruit 40 participants from St. Michael's Hospital, to learn whether it will be feasible to plan a larger study.
Read the detailed description
Indication: Adult patients undergoing spine surgery Condition: Perioperative pain management Number of participants 40 Primary outcome Feasibility (recruitment success, consent rate, adherence, patient withdrawal, missing data, adverse outcomes) Secondary outcome 1) Average pain intensity; 2) Rate of respiratory depression and postoperative ileus; 3) Use of opioids in morphine equivalents; 4) Quality of recovery Study design
- Interventional trial
- Allocation: Randomized
- Intervention model: 2-Arm Parallel-Group
- Primary purpose: Feasibility
- Phase: Phase IV
Masking Participants and Outcome Assessors
Study Intervention:
- Intervention Arm: Methadone 0.2mg/kg of ideal body weight via rectal administration + standard or care
- Placebo Arm: Saline solution via rectal administration + standard of care
Follow-Up: Postoperative days 1, 2, 3, and 30
- Being tested
- Rectal Methadone administer during spinal surgery, Placebo: Rectal saline solution
- Keywords
- Intraoperative Methadone, Rectal Methadone administration, spinal surgery post-operative pain management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal Methadone administer during spinal surgeryDrug
Rectal Methadone administered during spinal surgery for post-operative pain management
Placebo: Rectal saline solutionOther
Placebo: Rectal saline solution single dose received during surgery
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm with Methadone | Experimental | During the spinal surgery intervention, participants receive a single dose of 0.2mg/kg of Methadone rectally, after anesthesia induction. Receives: Drug: Rectal Methadone administer during spinal surgery |
| Placebo arm | Placebo comparator | During the spinal surgery intervention, participants receive a single dose of saline solution rectally after anesthesia induction. Receives: Other: Placebo: Rectal saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility to recruit 40 participants into a trial of methadone and placebo
Recruitment rate (Acceptability and feasibility study)
Measured: 18 months
Feasibility to recruit 40 participants into a trial of methadone and placebo
Withdrawal rate (Acceptability and feasibility study)
Measured: 18 months
Secondary outcomes (6)
Adverse outcomes
Rate of postoperative respiratory depression
Measured: At 24, 48, and 72 hours post operative
Adverse outcomes
Rate of postoperative ileus
Measured: At 24, 48, and 72 hours post operative
Opioid reduction
Total morphine equivalent used
Measured: At 24, 48, and 72 hours post operative
Pain intensity after surgery
Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS) Pain Intensity, Pain intensity scale- 0 to 10 (The higher the number the higher the pain intensity)
Measured: At 24, 48, and 72 hours post operative
Quality of Recovery
Quality of Recovery (QoR-15) Score, 15 items are rated on a 0-10 scale, with the total possible score ranging from 0 to 150, where higher scores indicate better recovery.
Measured: At 24, 48, and 72 hours post operative
Pain interference
Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS 6 a. 6 items, 5 Likert scale (the higher the score the higher the interference from pain)
Measured: Difference between Baseline and 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start19 Feb 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Spinal SurgeryStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo control trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- AFP Innovation Fund
- Responsible party
- Sponsor
- Investigators
- Sergio Pereira, MD PhD, Principal investigator, St. Michael's Hospital. Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843174
- Sponsor's protocol ID
- P-004
- Acronym
- PROMISE
- Status last verified
- Oct 2026
- First submitted
- 11 Feb 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a feasibility pilot trial only.
Publications
Dale O, Sheffels P, Kharasch ED. Bioavailabilities of rectal and oral methadone in healthy subjects. Br J Clin Pharmacol. 2004 Aug;58(2):156-62. doi: 10.1111/j.1365-2125.2004.02116.x.
PubMed 15255797Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur MA, Vender JS, Benson J, Newmark RL. Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Posterior Spinal Fusion Surgery: A Randomized, Double-blinded, Controlled Trial. Anesthesiology. 2017 May;126(5):822-833. doi: 10.1097/ALN.0000000000001609.
PubMed 28418966Machado FC, Vieira JE, de Orange FA, Ashmawi HA. Intraoperative Methadone Reduces Pain and Opioid Consumption in Acute Postoperative Pain: A Systematic Review and Meta-analysis. Anesth Analg. 2019 Dec;129(6):1723-1732. doi: 10.1213/ANE.0000000000004404.
PubMed 31743194Murphy GS, Avram MJ, Greenberg SB, Shear TD, Deshur MA, Dickerson D, Bilimoria S, Benson J, Maher CE, Trenk GJ, Teister KJ, Szokol JW. Postoperative Pain and Analgesic Requirements in the First Year after Intraoperative Methadone for Complex Spine and Cardiac Surgery. Anesthesiology. 2020 Feb;132(2):330-342. doi: 10.1097/ALN.0000000000003025.
PubMed 31939849Machado FC, Palmeira CCA, Torres JNL, Vieira JE, Ashmawi HA. Intraoperative use of methadone improves control of postoperative pain in morbidly obese patients: a randomized controlled study. J Pain Res. 2018 Oct 2;11:2123-2129. doi: 10.2147/JPR.S172235. eCollection 2018.
PubMed 30323647Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.
PubMed 20418538Elliott K, Kest B, Man A, Kao B, Inturrisi CE. N-methyl-D-aspartate (NMDA) receptors, mu and kappa opioid tolerance, and perspectives on new analgesic drug development. Neuropsychopharmacology. 1995 Dec;13(4):347-56. doi: 10.1016/0893-133X(95)00083-P.
PubMed 8747759Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
PubMed 18443635American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
PubMed 22227789Weir S, Samnaliev M, Kuo TC, Ni Choitir C, Tierney TS, Cumming D, Bruce J, Manca A, Taylor RS, Eldabe S. The incidence and healthcare costs of persistent postoperative pain following lumbar spine surgery in the UK: a cohort study using the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES). BMJ Open. 2017 Sep 11;7(9):e017585. doi: 10.1136/bmjopen-2017-017585.
PubMed 28893756Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
PubMed 23392233Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.
PubMed 29026331Puvanesarajah V, Liauw JA, Lo SF, Lina IA, Witham TF, Gottschalk A. Analgesic therapy for major spine surgery. Neurosurg Rev. 2015 Jul;38(3):407-18; discussion 419. doi: 10.1007/s10143-015-0605-7. Epub 2015 Feb 14.
PubMed 25680636
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Rectal Methadone in Spine Surgery
- ClinicalTrials.gov ID
- NCT06843174
- Acronym / sponsor ID
- PROMISE / P-004
- Keywords
- Intraoperative Methadone, Rectal Methadone administration, spinal surgery post-operative pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- AFP Innovation Fund
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Feb 2025 (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.
Patients undergoing spinal surgery require pain control medication after their surgery. Investigators have successfully used intravenous Methadone to manage pain after surgery. However, doctors in Canada do not have the intravenous form of Methadone to prescribe to their patients. The investigators in Canada propose a pilot trial to investigate whether Methadone administered rectally could be used to manage pain after spinal surgery.
The main questions are:
- Are investigators able to recruit participants for this trial and learn from this study to plan a larger trial?
- Does Methadone administered rectally during surgery, reduce participants' pain intensity, use less pain medication, and have a better recovery after surgery? Investigators will compare Methadone to a placebo (a look-alike substance that contains no drug) to see if Methadone works to manage pain after surgery better than the usual pain management.
Participants will:
- receive either Methadone or placebo during surgery.
- be asked some questions about their pain during days 1 to 3 after surgery
- be contacted by phone to ask about their recovery
At this time, the study aims to recruit 40 participants from St. Michael's Hospital, to learn whether it will be feasible to plan a larger study.
Detailed description
Indication: Adult patients undergoing spine surgery Condition: Perioperative pain management Number of participants 40 Primary outcome Feasibility (recruitment success, consent rate, adherence, patient withdrawal, missing data, adverse outcomes) Secondary outcome 1) Average pain intensity; 2) Rate of respiratory depression and postoperative ileus; 3) Use of opioids in morphine equivalents; 4) Quality of recovery Study design
- Interventional trial
- Allocation: Randomized
- Intervention model: 2-Arm Parallel-Group
- Primary purpose: Feasibility
- Phase: Phase IV
Masking Participants and Outcome Assessors
Study Intervention:
- Intervention Arm: Methadone 0.2mg/kg of ideal body weight via rectal administration + standard or care
- Placebo Arm: Saline solution via rectal administration + standard of care
Follow-Up: Postoperative days 1, 2, 3, and 30
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo control trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm with Methadone | Experimental | Drug: Rectal Methadone administer during spinal surgeryDuring the spinal surgery intervention, participants receive a single dose of 0.2mg/kg of Methadone rectally, after anesthesia induction. |
| Placebo arm | Placebo comparator | Other: Placebo: Rectal saline solutionDuring the spinal surgery intervention, participants receive a single dose of saline solution rectally after anesthesia induction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or older
- Elective spinal surgery with fusion of one or more sacral, lumbar, thoracic, and/or cervical levels
- Capacity to provide informed consent
- For participants of childbearing potential, use of contraception.
Key exclusion criteria (16 listed)
- American Society of Anesthesiologists Physical Status > IV
- Hypersensitivity to the active substance (methadone hydrochloride) or other opioid analgesics or to any ingredient in the formulation
- Pregnant or nursing participants
- Known or suspected mechanical gastrointestinal obstruction
- Acute respiratory depression, elevated carbon dioxide levels in the blood, cor pulmonale, or pulmonary disease necessitating home oxygen therapy
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 |
|---|---|---|
| Rectal Methadone administer during spinal surgeryRectal Methadone administered during spinal surgery for post-operative pain management | Drug | Intervention Arm with Methadone |
| Placebo: Rectal saline solutionPlacebo: Rectal saline solution single dose received during surgery | Other | Placebo arm |
Primary outcome
Feasibility to recruit 40 participants into a trial of methadone and placebo
Time frame: 18 months
Recruitment rate (Acceptability and feasibility study)
Feasibility to recruit 40 participants into a trial of methadone and placebo
Time frame: 18 months
Withdrawal rate (Acceptability and feasibility study)
6 secondary outcomes
Adverse outcomes
Time frame: At 24, 48, and 72 hours post operative
Adverse outcomes
Time frame: At 24, 48, and 72 hours post operative
Opioid reduction
Time frame: At 24, 48, and 72 hours post operative
Pain intensity after surgery
Time frame: At 24, 48, and 72 hours post operative
Quality of Recovery
Time frame: At 24, 48, and 72 hours post operative
Pain interference
Time frame: Difference between Baseline and 30 days after surgery
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 Oct 2026.
- Background: PubMed 15255797Dale O, Sheffels P, Kharasch ED. Bioavailabilities of rectal and oral methadone in healthy subjects. Br J Clin Pharmacol. 2004 Aug;58(2):156-62. doi: 10.1111/j.1365-2125.2004.02116.x.
- Background: PubMed 28418966Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur MA, Vender JS, Benson J, Newmark RL. Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Posterior Spinal Fusion Surgery: A Randomized, Double-blinded, Controlled Trial. Anesthesiology. 2017 May;126(5):822-833. doi: 10.1097/ALN.0000000000001609.
- Background: PubMed 31743194Machado FC, Vieira JE, de Orange FA, Ashmawi HA. Intraoperative Methadone Reduces Pain and Opioid Consumption in Acute Postoperative Pain: A Systematic Review and Meta-analysis. Anesth Analg. 2019 Dec;129(6):1723-1732. doi: 10.1213/ANE.0000000000004404.
- Background: PubMed 31939849Murphy GS, Avram MJ, Greenberg SB, Shear TD, Deshur MA, Dickerson D, Bilimoria S, Benson J, Maher CE, Trenk GJ, Teister KJ, Szokol JW. Postoperative Pain and Analgesic Requirements in the First Year after Intraoperative Methadone for Complex Spine and Cardiac Surgery. Anesthesiology. 2020 Feb;132(2):330-342. doi: 10.1097/ALN.0000000000003025.
- Background: PubMed 30323647Machado FC, Palmeira CCA, Torres JNL, Vieira JE, Ashmawi HA. Intraoperative use of methadone improves control of postoperative pain in morbidly obese patients: a randomized controlled study. J Pain Res. 2018 Oct 2;11:2123-2129. doi: 10.2147/JPR.S172235. eCollection 2018.
- Background: PubMed 20418538Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.
- Background: PubMed 8747759Elliott K, Kest B, Man A, Kao B, Inturrisi CE. N-methyl-D-aspartate (NMDA) receptors, mu and kappa opioid tolerance, and perspectives on new analgesic drug development. Neuropsychopharmacology. 1995 Dec;13(4):347-56. doi: 10.1016/0893-133X(95)00083-P.
- Background: PubMed 18443635Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
- Background: PubMed 22227789American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
- Background: PubMed 28893756Weir S, Samnaliev M, Kuo TC, Ni Choitir C, Tierney TS, Cumming D, Bruce J, Manca A, Taylor RS, Eldabe S. The incidence and healthcare costs of persistent postoperative pain following lumbar spine surgery in the UK: a cohort study using the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES). BMJ Open. 2017 Sep 11;7(9):e017585. doi: 10.1136/bmjopen-2017-017585.
- Background: PubMed 23392233Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
- Background: PubMed 29026331Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.
- Individual participant dataSharing planned: No. This is a feasibility pilot trial only.
Related trials for Spinal Surgery
RecruitingObservational study
Prevalence of Pain During Cesarean Section
Cesarean Birth
RecruitingPhase 1/2
Stimulation-based Therapy to Improve Balance in DCM
Degenerative Cervical Myelopathy
Recruiting
Surgical Treatment of Adjacent Segment Stenosis
Adjacent Segment Disease, Lumbar Spinal Stenosis
Not yet recruitingPhase 4
Remimazolam vs Propofol for Motor and Somatosensory Evoked Potentials in Spinal Tumor Surgery
Spinal Cord Neoplasms, Spinal Neoplasms
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
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.
Janneth A Pazmino-Canizares, MSc contact
Sergio Pereira, MD PhD principal investigator
St. Michael's Hospital. Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rectal Methadone administer during spinal surgery in people with Spinal Surgery and Post-operative Care, run by Unity Health Toronto 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 4 inclusion and 16 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 Oct 2026. 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 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?
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 Sergio Pereira, MD PhD (416-360-4000 ext. 49308, Sergio.Pereira@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility to recruit 40 participants into a trial of methadone and placebo (time frame: 18 months). The study lists 2 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 NCT06843174, which also lists 13 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 30 Oct 2026.