The Experiences of People Prescribed Opioid Pain Medicines

Pain Clinical Trial

Official title:

A Mixed Methods Study Investigating the Experiences, and Information and Support Needs, of People Prescribed Opioids, and the Role of Community Pharmacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04888897
• Other study ID #: 21009
• Secondary ID: 289857
• Status: Completed
• Start date: October 19, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2022
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 619
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Opioid Use
• Pain

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Nottingham

Sponsors (3)

Lead Sponsor	Collaborator
University of Nottingham	Boots UK, National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 -12 months
Secondary	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.	6 - 12 months
Secondary	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.	6 -12 months
Secondary	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.	6 -12 months