PainNCT04888897
The Experiences of People Prescribed Opioid Pain Medicines
An observational study of Pain and Opioid Use, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Opioids are morphine-type medicines which come from the opium poppy or are similar-to morphine. They are very effective for short-term pain, cancer pain, and pain at the end of life. Opioids are thought to be less useful for treating long-term non-cancer pain. Side effects are common and can be serious. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Opioid Use
- How many people
- 619 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Oct 2021to 1 Dec 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients registered with a GP practice in England who have been prescribed an opioid medicine for non-cancer pain by their GP over a period of at least 3 months. Purposive sampling of GP practices within the NIHR CRN East Midlands is planned. We aim to utilise a sample of practices with a range of characteristics which are representative of GP practices across the East Midlands.
Who may be able to join
- Ability to give informed consent
- Adults aged 18 years and above, with no upper age limit
- Prescribed any opioid analgesic (defined as any opioid or opioid/paracetamol combination analgesic from sections 4.7.2 and 4.7.1 British National Formulary) for non-cancer pain for a period of ≥3 months (defined as ≥ 2 opioid prescriptions issued in the previous 3 months with a minimum interval of 60 days between the first and last prescription)
Who cannot join
- Cancer pain
- Terminal illness
- Vulnerable patients (e.g. severe mental illness, learning difficulties, dementia, care home residents)
- Unable to understand English
- Deemed by their GP to be inappropriate to contact
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mixed Methods Study Investigating the Experiences, and Information and Support Needs, of People Prescribed Opioids, and the Role of Community Pharmacy
Opioids are morphine-type medicines which come from the opium poppy or are similar-to morphine. They are very effective for short-term pain, cancer pain, and pain at the end of life. Opioids are thought to be less useful for treating long-term non-cancer pain. Side effects are common and can be serious. People who take opioids for longer periods are at risk of tolerance (needing a higher dose to get the same effect), dependence (unable to cut down or stop without withdrawal effects), and addiction (uncontrollable use despite harmful consequences).
In the UK, opioid prescribing has increased substantially over the last two decades. Doses are higher and opioids are taken for longer, suggesting many people are at risk of harmful effects without useful pain relief. Research into opioid dependence and addiction has found people do not always fully understand the risks of these medicines at the start of treatment. Local Community Pharmacists could be used to improve information and support for those prescribed opioids.
Read more
This study aims to get a better understanding of the experiences of people prescribed opioids and their information and support needs, and to investigate whether information and support could be improved using Community Pharmacists. Findings may improve care for people prescribed opioids in the future.
The study will involve questionnaires and interviews with adults prescribed an opioid medicine for pain, not caused by cancer, over a period of at least 3 months. Participants will be recruited from GP practices in England.
- Conditions
- Pain, Opioid Use
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify whether people prescribed opioids for non-cancer pain need more information and support at the start of treatment.
The information and support needs of patients will be explored through the study questionnaire and interviews.
Measured: 6 -12 months
Secondary outcomes (3)
To assess and explore the difficulties experienced by people prescribed opioids for non-cancer pain.
Determined by the Prescribed Opioid Difficulties Scale (PODS) within the study questionnaire and qualitative interviews.
Measured: 6 - 12 months
To explore the perceptions of people prescribed opioids for non-cancer pain on the information they received and the need for improved information and support at the start of treatment
Explored through related items in the questionnaire and qualitative interviews.
Measured: 6 -12 months
To investigate the use of pharmacy by people prescribed opioids for non-cancer pain and their views on using community pharmacists to provide additional information and support for opioid pain medicines
Explored through related items in the questionnaire and qualitative interviews.
Measured: 6 -12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start19 Oct 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 619 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Boots UK, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Matthew J Boyd, PhD, Principal investigator, Associate Professor, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888897
- Sponsor's protocol ID
- 21009
- Other IDs
- 289857
- Status last verified
- Dec 2022
- First submitted
- 11 May 2021
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed Methods Study Investigating the Experiences, and Information and Support Needs, of People Prescribed Opioids, and the Role of Community Pharmacy
- ClinicalTrials.gov ID
- NCT04888897
- Acronym / sponsor ID
- 21009
- Conditions
- Pain, Opioid Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 619 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Boots UK, National Institute for Health Research, United Kingdom
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 17 May 2021 (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.
Opioids are morphine-type medicines which come from the opium poppy or are similar-to morphine. They are very effective for short-term pain, cancer pain, and pain at the end of life. Opioids are thought to be less useful for treating long-term non-cancer pain. Side effects are common and can be serious. People who take opioids for longer periods are at risk of tolerance (needing a higher dose to get the same effect), dependence (unable to cut down or stop without withdrawal effects), and addiction (uncontrollable use despite harmful consequences).
In the UK, opioid prescribing has increased substantially over the last two decades. Doses are higher and opioids are taken for longer, suggesting many people are at risk of harmful effects without useful pain relief. Research into opioid dependence and addiction has found people do not always fully understand the risks of these medicines at the start of treatment. Local Community Pharmacists could be used to improve information and support for those prescribed opioids.
This study aims to get a better understanding of the experiences of people prescribed opioids and their information and support needs, and to investigate whether information and support could be improved using Community Pharmacists. Findings may improve care for people prescribed opioids in the future.
The study will involve questionnaires and interviews with adults prescribed an opioid medicine for pain, not caused by cancer, over a period of at least 3 months. Participants will be recruited from GP practices in England.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients registered with a GP practice in England who have been prescribed an opioid medicine for non-cancer pain by their GP over a period of at least 3 months. Purposive sampling of GP practices within the NIHR CRN East Midlands is planned. We aim to utilise a sample of practices with a range of characteristics which are representative of GP practices across the East Midlands.
Key inclusion criteria (3 listed)
- Ability to give informed consent
- Adults aged 18 years and above, with no upper age limit
- Prescribed any opioid analgesic (defined as any opioid or opioid/paracetamol combination analgesic from sections 4.7.2 and 4.7.1 British National Formulary) for non-cancer pain for a period of ≥3 months (defined as ≥ 2 opioid prescriptions issued in the previous 3 months with a minimum interval of 60 days between the first and last prescription)
Key exclusion criteria (5 listed)
- Cancer pain
- Terminal illness
- Vulnerable patients (e.g. severe mental illness, learning difficulties, dementia, care home residents)
- Unable to understand English
- Deemed by their GP to be inappropriate to contact
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify whether people prescribed opioids for non-cancer pain need more information and support at the start of treatment.
Time frame: 6 -12 months
The information and support needs of patients will be explored through the study questionnaire and interviews.
3 secondary outcomes
To assess and explore the difficulties experienced by people prescribed opioids for non-cancer pain.
Time frame: 6 - 12 months
To explore the perceptions of people prescribed opioids for non-cancer pain on the information they received and the need for improved information and support at the start of treatment
Time frame: 6 -12 months
To investigate the use of pharmacy by people prescribed opioids for non-cancer pain and their views on using community pharmacists to provide additional information and support for opioid pain medicines
Time frame: 6 -12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- 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.
Matthew J Boyd, PhD principal investigator
Associate Professor, University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Opioid Use, run by University of Nottingham 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 5 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: finished, as of the sponsor's last update on 21 Dec 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To identify whether people prescribed opioids for non-cancer pain need more information and support at the start of treatment. (time frame: 6 -12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2022.