The Experiences of People Prescribed Opioid Pain Medicines

NCT ID: NCT04888897

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

619 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-19

Study Completion Date

2022-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Opioid Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boots UK

UNKNOWN

Sponsor Role collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matthew J Boyd, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, University of Nottingham

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Nottingham

Nottingham, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

289857

Identifier Type: OTHER

Identifier Source: secondary_id

21009

Identifier Type: -

Identifier Source: org_study_id