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Completed

NCT Number: NCT04888897

The Experiences of People Prescribed Opioid Pain Medicines

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.

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Key information

Conditions

Pain Neurologic Manifestations Opioid Use Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nottingham

Nottingham, NG7 2RD, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. To assess and explore the difficulties experienced by people prescribed opioids for non-cancer pain.

    Time frame: 6 - 12 months

    Determined by the Prescribed Opioid Difficulties Scale (PODS) within the study questionnaire and qualitative interviews.

  2. 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

    Explored through related items in the questionnaire and qualitative interviews.

  3. 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

    Explored through related items in the questionnaire and qualitative interviews.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Boots UK
  • National Institute for Health Research, United Kingdom

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 17, 2021
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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