Opioid DependenceDESCALENCT06396663
DE-eSCALation of Opioids Post-surgical dischargE
A study testing Rapid Opioid de-escalation, Gradual Opioid de-escalation and Continuation of opioids in people with Opioid Dependence, run by University of Kent at 1 site in United Kingdom.
Trial summary
The Descale Study aims to: 1. Look at the prescribing trends of opioids and the scale of long-term use following surgery within East Kent (United Kingdom) 2. Carry out a feasibility study to: see if clinical pharmacists can support patients following surgery to manage their post-surgical pain safely and prevent… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- Rapid Opioid de-escalation, Gradual Opioid de-escalation and Continuation of opioids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jan 2024to Sep 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years old or above.
- Undergone surgery and discharged with opioid medication* less than 120mg MME/day from a participating hospital and taking it for the treatment of acute non-malignant post-surgical pain.
- Investigators have used the British National Formulary (BNF) definition of opioids and will recruit participants who have been prescribed one or more of the following drugs: Codeine, Dihydrocodeine, Buprenorphine transdermal patches, Fentanyl transdermal patches, Morphine, Oxycodone, Tramadol, Diamorphine, Dipipanone, Tapentadol, Pentazocine.
Who cannot join
- Aged under 18 years of age.
- Unable to provide written informed consent.
- More than 90 days opioid use pre-surgery.
- On > 120 mg MME/day.
- Additional surgical procedures planned during the 3-month intervention.
- A history of methadone treatment.
Show all 12Show fewer
- Regularly inject opioids.
- Using opioids for malignant pain.
- Undergone a caesarean section.
- Is pregnant*.
- Classified as vulnerable (e.g., severe dementia, severe co-existing or terminal medical condition).
- Risk of miscarriage or stillbirth from opioid withdrawal
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Newton Place Surgery
Faversham, Kent, ME13 8FH
Research Team, 000-000-0000 ext. +4401795530777, descalestudy@kent.ac.uk
Dr Short
About this study
Official title: The Role of the Clinical Pharmacist in Reducing Opioid Dependence at the Interface Between Hospital and Primary Care
The Descale Study aims to:
- Look at the prescribing trends of opioids and the scale of long-term use following surgery within East Kent (United Kingdom)
- Carry out a feasibility study to:
Read more
- see if clinical pharmacists can support patients following surgery to manage their post-surgical pain safely and prevent long-term opioid use
- calculate how much it costs the National Health Service (NHS)
- see how the patients experienced the intervention
For Aim 1, historic records of patients who have had surgery and were discharged on opioids will be reviewed. Data collected will include type and strength of pain-relieving medication prescribed; type of surgery; number of additional opioid prescriptions following discharge; use of medical services (e.g., General Practice appointments, physiotherapy); and patient demographics.
For Aim 2, clinical pharmacists will carry out early high-risk medication safety reviews to ensure that patients have their pain managed safely. Investigators will collect key data from patients receiving the clinical pharmacist intervention to see how it affected opioid use, costs and healthcare use. Patients who took part in the study will be invited to participate in an interview and will be asked what they know about opioids and the health risks, and their experiences of the intervention.
- Conditions
- Opioid Dependence
- Being tested
- Rapid Opioid de-escalation, Gradual Opioid de-escalation, Continuation of opioids
- Keywords
- Prescribing, Surgery, Pain, De-escalation
- Medical subject headings
- Opioid-Related Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Opioid de-escalationOther
Option 1: 10% - 50% decrease/day until opioids discontinued (≤ 10 days). For Fentanyl patches in decrements of 12 mcg/hr.
Option 2: Stop all opioid medication completely
Gradual Opioid de-escalationOther
Option 1: 20% - 50% decrease/weekly until opioids discontinued Option 2: 10% - 20% decrease/weekly until 30 mg daily. Then reduce by 5% - 10% everyday.
Continuation of opioidsOther
Continue on opioids and review in 1 weeks time.
| Study group | Role | What they receive |
|---|---|---|
| Opioid de-escalation | Experimental | An early opioid deprescribing intervention, delivered by clinical pharmacists, targeting surgical patients discharged from one-of-three East Kent University Foundation Trust hospitals, with opioids. Receives: Other: Rapid Opioid de-escalation; Other: Gradual Opioid de-escalation; Other: Continuation of opioids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the fidelity of an early opioid deprescribing intervention led by trained clinical pharmacists in primary care and their role in the wider medicine's optimisation programme.
Measure the capabilities of trained clinical pharmacists to deliver an early opioid medication review by completed intervention delivery training.
Measured: Month 3
Determination of the fidelity of an early opioid deprescribing intervention led by trained clinical pharmacists in primary care and their role in the wider medicine's optimisation programme.
Measure the capabilities of trained clinical pharmacists to deliver an early opioid medication review by observational competency checks by clinical lead.
Measured: Month 3
Determination of the fidelity of an early opioid deprescribing intervention led by trained clinical pharmacists in primary care and their role in the wider medicine's optimisation programme.
Measure the capabilities of trained clinical pharmacists to deliver an early opioid medication review by completed medication review case reports.
Measured: Month 3
Determination of the fidelity of an early opioid deprescribing intervention led by trained clinical pharmacists in primary care and their role in the wider medicine's optimisation programme.
Measure the capabilities of trained clinical pharmacists to deliver an early opioid medication review by the number of participants successfully deescalated.
Measured: Month 3
Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the NHS stakeholders.
Maintain detailed records of any barriers or enablers that may occur in response to setting up the intervention and whilst delivering the intervention. Captured via Stakeholder Interviews.
Measured: Up to 3 months after final follow up
Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
Ascertain participant satisfaction of the intervention by measuring the number of participants that enrol in the study.
Measured: Up to 3 months after final follow up
Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
Ascertain participant satisfaction of the intervention by measuring the number of withdrawals from the study.
Measured: Up to 3 months after final follow up
Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
Ascertain participant satisfaction of the intervention by measuring the adherence to pharmacist medication recommendations.
Measured: Up to 3 months after final follow up
Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
Ascertain participant satisfaction of the intervention by measuring the responses to participant satisfaction questionnaire.
Measured: Up to 3 months after final follow up
Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
Ascertain participant satisfaction of the intervention by measuring the responses to participant interviews.
Measured: Up to 3 months after final follow up
Establishment of the cost of delivering the intervention from the health/social care provider (NHS), perspective.
Apply a micro-costing approach to estimate the intervention costs (combining opioid medication costs and staff costs, with Health resource use (primary care services, community-based services, hospital inpatient and outpatient services) to establish overall cost).
Measured: Up to 3 months after the end of recruitment
Secondary outcomes (16)
Determination of the percentage of participants that reduce or stop opioids in 90 days
Measurement of the mean difference in morphine milligram equivalent (MME) dose at baseline and at 90 days.
Measured: Month 3
Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
Collect medication use data at baseline and at all follow-up appointments.
Measured: After the final follow up, up to 3 months
Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
Compare opioid prescribing (type, dose, amount) at baseline for each surgical speciality and hospital.
Measured: After the final follow up, up to 3 months
Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
Measure pain scores at baseline and final visits.
Measured: After the final follow up, up to 3 months
Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
Measurement of risk factors in the participant population that have been previously linked to long-term opioid use, from Baseline demographics and Medical, prescription and surgical histories.
Measured: After the final follow up, up to 3 months
Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
Response to Quality-Of-Life questionnaire (The EuroQol-5 Dimension (EQ5D-5L)) complete at baseline and final appointment.
Measured: After the final follow up, up to 3 months
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Measurements of time spent finding and recruiting participants.
Measured: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Measurement of number of possible surgical participants per week that could receive intervention.
Measured: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Measurement of number of pharmacists available to deliver the intervention.
Measured: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Measurement of number of surgical participants that accept an early Medicines Utilisation Review versus the number that are asked.
Measured: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Measurement of time taken from hospital discharge to receiving first Medicines Utilisation Review.
Measured: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Average time taken for each appointment.
Measured: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Average time taken to successfully deescalate opioids in surgical patients.
Measured: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Number of participants that are successfully deprescribed opioids within 3 months.
Measured: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Number of patients that require additional appointments with the pharmacist.
Measured: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Number of participants that require additional support post-90 days.
Measured: Up to 3 months after final follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start11 Jan 2024
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Opioid DependenceStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kent
- Sponsor type
- University, hospital or other
- Collaborators
- Kent Community Health NHS Foundation Trust, NHS Kent and Medway
- Responsible party
- Sponsor
- Investigators
- Dr Emma Veale, Principal investigator, University of KentDr Johanna Theron, Principal investigator, Kent Community Health NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396663
- Sponsor's protocol ID
- University of Kent
- Acronym
- DESCALE
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
PubMed 28403427Jani M, Birlie Yimer B, Sheppard T, Lunt M, Dixon WG. Time trends and prescribing patterns of opioid drugs in UK primary care patients with non-cancer pain: A retrospective cohort study. PLoS Med. 2020 Oct 15;17(10):e1003270. doi: 10.1371/journal.pmed.1003270. eCollection 2020 Oct.
PubMed 33057368Benyamin 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 18443635
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Clinical Pharmacist in Reducing Opioid Dependence at the Interface Between Hospital and Primary Care
- ClinicalTrials.gov ID
- NCT06396663
- Acronym / sponsor ID
- DESCALE / University of Kent
- Conditions
- Opioid Dependence
- Keywords
- Prescribing, Surgery, Pain, De-escalation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of KentUniversity, hospital or other
- Collaborators
- Kent Community Health NHS Foundation Trust, NHS Kent and Medway
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 2 May 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 Descale Study aims to:
- Look at the prescribing trends of opioids and the scale of long-term use following surgery within East Kent (United Kingdom)
- Carry out a feasibility study to:
- see if clinical pharmacists can support patients following surgery to manage their post-surgical pain safely and prevent long-term opioid use
- calculate how much it costs the National Health Service (NHS)
- see how the patients experienced the intervention
For Aim 1, historic records of patients who have had surgery and were discharged on opioids will be reviewed. Data collected will include type and strength of pain-relieving medication prescribed; type of surgery; number of additional opioid prescriptions following discharge; use of medical services (e.g., General Practice appointments, physiotherapy); and patient demographics.
For Aim 2, clinical pharmacists will carry out early high-risk medication safety reviews to ensure that patients have their pain managed safely. Investigators will collect key data from patients receiving the clinical pharmacist intervention to see how it affected opioid use, costs and healthcare use. Patients who took part in the study will be invited to participate in an interview and will be asked what they know about opioids and the health risks, and their experiences of the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Opioid de-escalation | Experimental | Other: Rapid Opioid de-escalation, Other: Gradual Opioid de-escalation, Other: Continuation of opioidsAn early opioid deprescribing intervention, delivered by clinical pharmacists, targeting surgical patients discharged from one-of-three East Kent University Foundation Trust hospitals, with opioids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years old or above.
- Undergone surgery and discharged with opioid medication* less than 120mg MME/day from a participating hospital and taking it for the treatment of acute non-malignant post-surgical pain.
Key exclusion criteria (12 listed)
- Aged under 18 years of age.
- Unable to provide written informed consent.
- More than 90 days opioid use pre-surgery.
- On > 120 mg MME/day.
- Additional surgical procedures planned during the 3-month intervention.
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 |
|---|---|---|
| Rapid Opioid de-escalationOption 1: 10% - 50% decrease/day until opioids discontinued (≤ 10 days). For Fentanyl patches in decrements of 12 mcg/hr. Option 2: Stop all opioid medication completely | Other | Opioid de-escalation |
| Gradual Opioid de-escalationOption 1: 20% - 50% decrease/weekly until opioids discontinued Option 2: 10% - 20% decrease/weekly until 30 mg daily. Then reduce by 5% - 10% everyday. | Other | Opioid de-escalation |
| Continuation of opioidsContinue on opioids and review in 1 weeks time. | Other | Opioid de-escalation |
Primary outcome
Determination of the fidelity of an early opioid deprescribing intervention led by trained clinical pharmacists in primary care and their role in the wider medicine's optimisation programme.
Time frame: Month 3
Measure the capabilities of trained clinical pharmacists to deliver an early opioid medication review by completed intervention delivery training.
Determination of the fidelity of an early opioid deprescribing intervention led by trained clinical pharmacists in primary care and their role in the wider medicine's optimisation programme.
Time frame: Month 3
Measure the capabilities of trained clinical pharmacists to deliver an early opioid medication review by observational competency checks by clinical lead.
Determination of the fidelity of an early opioid deprescribing intervention led by trained clinical pharmacists in primary care and their role in the wider medicine's optimisation programme.
Time frame: Month 3
Measure the capabilities of trained clinical pharmacists to deliver an early opioid medication review by completed medication review case reports.
Determination of the fidelity of an early opioid deprescribing intervention led by trained clinical pharmacists in primary care and their role in the wider medicine's optimisation programme.
Time frame: Month 3
Measure the capabilities of trained clinical pharmacists to deliver an early opioid medication review by the number of participants successfully deescalated.
Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the NHS stakeholders.
Time frame: Up to 3 months after final follow up
Maintain detailed records of any barriers or enablers that may occur in response to setting up the intervention and whilst delivering the intervention. Captured via Stakeholder Interviews.
Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
Time frame: Up to 3 months after final follow up
Ascertain participant satisfaction of the intervention by measuring the number of participants that enrol in the study.
Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
Time frame: Up to 3 months after final follow up
Ascertain participant satisfaction of the intervention by measuring the number of withdrawals from the study.
Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
Time frame: Up to 3 months after final follow up
Ascertain participant satisfaction of the intervention by measuring the adherence to pharmacist medication recommendations.
Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
Time frame: Up to 3 months after final follow up
Ascertain participant satisfaction of the intervention by measuring the responses to participant satisfaction questionnaire.
Determination of the barriers/enablers that affect the delivery of the intervention from the perspective of the surgical patient.
Time frame: Up to 3 months after final follow up
Ascertain participant satisfaction of the intervention by measuring the responses to participant interviews.
Establishment of the cost of delivering the intervention from the health/social care provider (NHS), perspective.
Time frame: Up to 3 months after the end of recruitment
Apply a micro-costing approach to estimate the intervention costs (combining opioid medication costs and staff costs, with Health resource use (primary care services, community-based services, hospital inpatient and outpatient services) to establish overall cost).
16 secondary outcomes
Determination of the percentage of participants that reduce or stop opioids in 90 days
Time frame: Month 3
Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
Time frame: After the final follow up, up to 3 months
Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
Time frame: After the final follow up, up to 3 months
Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
Time frame: After the final follow up, up to 3 months
Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
Time frame: After the final follow up, up to 3 months
Obtaining an understanding of trends in surgical opioid prescribing, surgical related pain, and risk factors that contribute to long term opioid use.
Time frame: After the final follow up, up to 3 months
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Time frame: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Time frame: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Time frame: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Time frame: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Time frame: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Time frame: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Time frame: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Time frame: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Time frame: Up to 3 months after final follow up
Determination of the integrity, robustness, and transferability of the protocol for future adoption by the NHS.
Time frame: Up to 3 months after final follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Background: PubMed 28403427Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
- Background: PubMed 33057368Jani M, Birlie Yimer B, Sheppard T, Lunt M, Dixon WG. Time trends and prescribing patterns of opioid drugs in UK primary care patients with non-cancer pain: A retrospective cohort study. PLoS Med. 2020 Oct 15;17(10):e1003270. doi: 10.1371/journal.pmed.1003270. eCollection 2020 Oct.
- 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.
- Public Health England, 2019. Prescribed medicines review: clinical commission group data.Link provided by the sponsor.
- Public Health England, 2019, Dependence and withdrawal associated with some prescribed medicines.Link provided by the sponsor.
- Office of National Statistics, 2020. Deaths related to drug poisoning in England and Wales: 2020 registrations.Link provided by the sponsor.
- Surgery and the NHS in numbersLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Opioid Dependence
RecruitingPhase 2
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Headache
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 2
A Study of Cebranopadol for Opioid Withdrawal Symptoms in Adults With Chronic Pain
Chronic Pain, Pain
Active, not recruiting
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Opioid Dependence, Substance Abuse Disorders
RecruitingPhase 1
MethaLoad Dose-Finding Study
Opioid Use Disorder (OUD)
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.
Dr Emma Veale principal investigator
University of Kent
Dr Johanna Theron principal investigator
Kent Community Health NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Opioid de-escalation, Gradual Opioid de-escalation and Continuation of opioids in people with Opioid Dependence, run by University of Kent at 1 site in United Kingdom.
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 12 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: status not confirmed, as of the sponsor's last update on 2 May 2024. 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 Kingdom. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Research Coordinator (+441227764000, descalestudy@kent.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the fidelity of an early opioid deprescribing intervention led by trained clinical pharmacists in primary care and their role in the wider medicine's optimisation programme. (time frame: Month 3). The study lists 11 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 NCT06396663, which also lists 3 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 2 May 2024.