Authors' objectives: The long-term use of strong opioids for chronic non-cancer pain puts people at risk of serious harm. To test the effectiveness and cost-effectiveness of a multicomponent intervention targeting opioid use for the treatment of chronic pain. Chronic non-malignant pain is the leading cause of years lived with disability globally and is defined as pain that persists or recurs for longer than 3 months. Despite a lack of evidence that they improve pain, function or quality of life, opioids are widely used to treat chronic non-malignant pain. Adverse effects from opioids include sedation, nausea, respiratory depression/sleep apnoea, depression, abdominal pain, hormone imbalance, overdose and death. Up to 80% of opioid users report at least one adverse effect. In 2017, there were 110,000 deaths from opioid overuse disorder worldwide — a 77% increase from 2007 with further increase reported during the COVID-19 pandemic. Data published in 2020 from a retrospective cohort study using UK primary care electronic health records from the Clinical Practice Research Data Link found that between 2006 and 2017 a total of 1,968,742 new adult patients with chronic non-malignant pain were prescribed an opioid. Codeine was the most commonly prescribed opioid, with use increasing fivefold from 2006 to 2017, reaching 2456 prescriptions/10,000 people/year. Prescribing of other opioids such as morphine, buprenorphine, and oxycodone also continued to increase during this period. At the time we were developing this study, there were few data supporting interventions that assist people to reduce opioid doses. A 2017 Cochrane review found one randomised controlled trial of acupuncture (N = 35) and one of computerised therapeutic voice support (N = 51). The reviewers were unable to make recommendations for practice. This review also identified five observational studies (N = 1800) from one unit suggesting that an intensive 3-week pain management programme can substantially reduce opioid use. There have been three subsequent systematic reviews. Two reviews focused on opioid reduction interventions. They identified 10 randomised controlled trials of patient focused opioid de-prescribing interventions (n = 835). These trials did not show evidence of reduced opioid consumption or increased opioid cessation. The third review, looking at the wider pain management literature, included two trials of pain self-management (N = 238) in a meta-analysis that found positive effects on opioid cessation [odds ratio (OR) 2.15, 95% confidence interval (CI) 1.02 to 4.53] and five (N = 428) that found a reduced daily morphine equivalent dose of 14.3 (95% CI 7.1 to 21.6)]. These data suggest that a pain management programme might have some potential to reduce opioid use by people living with chronic non-malignant pain. An effective pain management programme that specifically targeted opioid use could be expected to help people live better with their pain both directly through its effect on pain self-efficacy and indirectly through an improved quality of life from reduced opioid use. However, an alternative outcome could be that successful opioid tapering leads to increased pain, and worse quality of life due to loss of their analgesic effect. This means that any trial of an opioid reduction intervention needs to consider both any changes in opioid uses and how pain affects people. Tapering opioids too quickly without a lack of alternatives to manage pain can cause substantial harm. Individuals motivated to reduce their opioid use need appropriate advice on how to do this safely. In the Improving the Wellbeing of People with Opioid Treated Chronic Pain (I-WOTCH) study, we tested the combination of a pain management approach and an individualised and supported opioid tapering plan on pain interference and opioid use.

Authors' results and conclusions: We randomised 608 people. At 12 months, there was no between-group difference in Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (8A) scores; mean difference, −0.52 (95% confidence interval −1.94 to 0.89). At 12 months, 65/225 (29%) of people in the intervention group and 15/208 (7%) of people in usual-care group reported using no opioids [odds ratio 5.55 (95% confidence interval 2.80 to 10.99)], absolute difference, 21.7% (95% confidence interval 14.8 to 28.6). Over a lifetime horizon, I-WOTCH is on average associated with an incremental cost of £9277 per person, and provides an additional 0.314 quality-adjusted life-years. The deterministic incremental cost per quality-adjusted life-year gained was £29,543. The I-WOTCH intervention may be cost-effective compared to best usual care. The process evaluation suggested group support and shared experience were important to those trying to taper. The I-WOTCH intervention helps substantially more people stop opioids than best usual care without adversely affecting pain interference. Between 17 May 2017 and 30 January 2019, we randomised 608 people after screening in 191 general practices, 3 hospitals, and allowing self-referrals. We randomised 303 to control and 305 to intervention; we ran a total of 35 intervention groups in 25 locations. At 12 months, 29% (65/225) in the intervention group and 7% (15/208) in the usual-care group had fully tapered off opioids [OR 5.55 (95% CI 2.80 to 10.99); p 

Authors' methods: A multicentred randomised controlled trial with embedded process evaluation. Primary care. Adults using strong opioids for non-malignant chronic. Participants were randomised 1 : 1 (using a minimisation programme stratified by geographical locality, baseline pain intensity score and baseline morphine equivalent dose) to either usual care (an educational booklet and relaxation compact disc) or usual care plus the I-WOTCH intervention; 3 day-long group sessions delivered by a nurse and lay facilitator, plus a one-to-one session and ongoing telephone contact from the nurse to support opioid tapering. The two primary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (8A), and proportion using no opioids, at 12 months. The opioid use analysis is based solely on participant self-report. The findings only apply to people willing to consider opioid reduction and may not apply to a more complex secondary care population. The results may not be applicable to people using very high opioid doses. We conducted a pragmatic, multicentre, 1 : 1 randomised controlled trial design to test the superiority of a multicomponent, psychologically informed, group self-management support programme, including a one-to-one discussion with a trained nurse and the development of an opioid tapering programme, against enhanced usual care for reducing opioid consumption in people with chronic non-malignant pain. The trial was approved by the Yorkshire and The Humber – South Yorkshire Research Ethics Committee on 13 September 2016 (16/YH/0325) and sponsored by the University of Warwick, UK. It was conducted according to good clinical practice guidance and overseen by an independent Trial Steering Committee, with an independent Data Monitoring and Ethics Committee. Participants were adults (aged ≥ 18) using strong opioids as defined in the British National Formulary (BNF) published at the time of the study design, for at least 3 months for chronic non-malignant pain, and on most days in the preceding month. Since the study was developed, the BNF has changed its approach and no longer makes a distinction between weak and strong opioids. To identify potential participants, general practices searched their records for people aged 18 years and over, who had more than one prescription for a strong opioid (buprenorphine, dipipanone, morphine, diamorphine, fentanyl, hydromorphone, methadone, oxycodone, papaveretum, pentazocine, pethidine, tapentadol and tramadol) in the previous 3–6 months and in the previous 0–3 months as indicated by their health record. General practices invited potentially eligible people to express an interest in the study. They excluded people known to be using opioids for malignant pain, care home residents, the housebound, and those using methadone not prescribed for chronic pain. People could also self-refer. Posters were placed in general practitioner surgeries, pharmacies, pain clinics and musculoskeletal physiotherapy clinics and the study website had details of the trial. We confirmed eligibility in a subsequent telephone call. Eligible participants then completed baseline questionnaires and returned signed consent forms. In a further telephone call, medication use, as reported in the baseline questionnaire, and consent to join the study were checked and confirmed. Participants were randomised 1 : 1 to either usual care or the I-WOTCH intervention. Both groups received enhanced usual care, including a booklet ‘My Opioid Manager’ based on the 2010 Canadian Opioid Guideline, a self-help guide containing information about pain, opioids and tapering, and a relaxation compact disc. The intervention group was offered the I-WOTCH intervention package. Two primary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (8A) (PROMIS-PI-SF-8A) (T-score range 40.7–77, 77 indicates worst pain interference) and the proportion of participants who discontinued opioids at 12 months, measured by self-report. Secondary outcomes were Patient-Reported Outcomes Measurement Information System Pain Intensity Short Form 3a (PROMIS-PI-SF-3A), severity of opioid withdrawal symptoms [Short Opiate Withdrawal Scale (ShOWS)], health-related quality of life [SF-12v2 health survey and EuroQol-5 Dimensions, five-level version (EQ-5D-5L)], sleep quality (Pittsburgh Sleep Quality Index), emotional well-being [Hospital Anxiety and Depression Scale (HADS)], self-efficacy (Pain Self-Efficacy Questionnaire), and proportion of patients who reduced opioids by 50% from baseline. All outcomes were collected at baseline, 4, 8 and 12 months.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/14/224/04

Year Published: 2026

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/GJHS2715

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/GJHS2715

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk