IMPORTANCE: Guidelines recommend dose reduction or discontinuation of long-term opioid therapy when harm outweighs benefit, but strategies to help patients do so are limited.
OBJECTIVE: To test optionally switching to buprenorphine as a strategy for improving pain and reducing opioids among patients prescribed high-dose, full agonist long-term opioid therapy.
DESIGN, SETTING, AND PARTICIPANTS: In this pragmatic, multisite, 12-month randomized clinical trial with masked outcome assessment, patients treated at Veterans Affairs primary care clinics were recruited from October 2017 to March 2021, with follow-up completed June 2022. Eligible patients had moderate to severe chronic pain despite high-dose opioid therapy (=70 mg/d for at least 3 months). Patients were randomized to having the option to switch to buprenorphine or not having the option to switch.
INTERVENTIONS: The buprenorphine option was discussed with eligible patients as part of a larger trial of collaborative pain care interventions. Those who switched had structured follow-up to optimize dosing and address adverse effects.
MAIN OUTCOMES AND MEASURES: The primary outcome was Brief Pain Inventory total score at 12 months. The main secondary outcome was opioid dose in morphine milligram equivalents at 12 months.
RESULTS: Of 207 included participants, 185 (89.4%) were male, and the mean (SD) age was 60.9 (10.2) years. A total of 104 were randomized to the buprenorphine option and 103 to the no buprenorphine option. In the buprenorphine option arm, 27 participants (26.0%) switched. Over 12 months, the mean (SD) Brief Pain Inventory score improved from 6.8 (1.5) to 6.1 (1.9; adjusted mean difference [AMD], -0.59; 95% CI, -0.89 to -0.29) in the buprenorphine option arm and from 6.8 (1.6) to 6.3 (1.7; AMD, -0.50; 95% CI, -0.81 to 0.20) in the no option arm (between-group AMD, -0.09; 95% CI, -0.52 to 0.34). Over 12 months, mean (SD) opioid dosage decreased from 157 (75) mg/d to 94 (98) mg/d in the buprenorphine option arm (AMD, -61.0 mg/d; 95% CI, -74.1 to -47.9) and from 165 (88) mg/d to 107 (89) mg/d (AMD, -58.5 mg/d; 95% CI, -71.6 to -45.4) in the no option arm (between-group AMD, -2.5 mg/d; 95% CI, -21.1 to 16.0).
CONCLUSIONS AND RELEVANCE: In this trial, outcomes did not differ between groups; both had small improvements in pain and substantial reductions in opioid dosage, but the proportion of participants who switched to buprenorphine was low.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03026790.
| Discipline Area | Score |
|---|---|
| Family Medicine (FM)/General Practice (GP) |  |
| General Internal Medicine-Primary Care(US) | |
| Special Interest - Pain -- Physician | |
Currently a very useful study with increasing chronic pain diagnoses and increasing opioid use across many countries. As a primary care physician, this is an important area and substituting buprenorphine for opioids is an important step to consider. The study shows it is not an easy switch with 33% of those moved to buprenorphine switching back to high-dose opioids. There are a couple limitations of the study: 1. it was done in veterans whose cause for chronic pain may be different to the general population; and 2. the small numbers involved. A larger trial across a general population along with a support programme on living well with long-term pain may be useful to decipher subgroups who may benefit more from the switch.
This pragmatic randomized study was conducted at 10 diverse sites, adhering to the Consolidated Standards of Reporting Trials (CONSORT) Reporting guideline. Cons: The study had variable rates of buprenorphine switching, and medication use was based on dispensed prescriptions. The findings may not be generalizable to all patients, as the majority of participants were male. Conclusion: Switching from high-dose full agonist opioids to buprenorphine did not improve pain severity or reduce opioid dosage. More research needs to be done.
Buprenorphine would not be expected to be more effective, simply potentially safer for some requiring long-term opioid therapy. All patients’ individualized benefit-risk ratio should be considered for all therapies used to manage all conditions; chronic pain is no different.
