Current opioid treatment guidelines recommend consideration of opioid dose escalation in patients with poorly-controlled chronic pain, despite equivocal efficacy data supporting such practice. Additionally, short and long-term risks, including overdose, hyperalgesia and hypogonadism, may increase with increasing opioid exposure. Due to the ceiling effect of partial agonists, buprenorphine/naloxone (BUP/NX) may be a safer alternative to opioid dose escalation, assuming a successful transition to BUP/NX and efficacy of the treatment, two facets of clinical care that have not been rigorously studied.
Among patients on 30-100mg morphine equivalents per day and evidence of poorly-controlled pain(elevated pain scores and marked functional interference): 1) To determine willingness to be enrolled in a trial of BUP/NX versus opioid dose escalation and reasons for and against enrollment. 2) To perform a 12-week, open label, pilot randomized trial of BUP/NX compared to opioid dose escalation on the primary outcome of pain intensity and secondary outcomes of pain interference, medication adherence and patient global impression of change
We mailed opt out letters to randomly selected patients within the target dose range. Individuals who did not opt out were contacted by phone for preliminary eligibility screening and assessment of willingness to enroll in the trial. Unwilling individuals were asked why they were not interested and willing individuals were scheduled for an intake appointment. Following informed consent, enrolled participants underwent a history and physical and were randomly assigned in a 1:1 allocation to opioid dose escalation or BUP/NX induction.
Of 114 opt-out letters sent, 95 patients opted out or were not reachable. Of the remaining 19, 12 were not willing to enter the trial. 7 patients entered the trial, 4 randomized to opioid dose escalation and 3 to BUP/NX. 2 patients withdrew from the study after enrolling.
Despite moderate to severe pain (numerical rating scale score greater than or equal to 4 and/or marked pain interference (Brief Pain Inventory functional module score greater than or equal to 28), the most common reason for unwillingness to enroll was satisfaction with current regiment. The second most common reason was inconvenience, especially related to travel.
This pilot trial has demonstrated significant challenges to the feasibility of a larger trial based on barriers identified at the patient, provider and system levels.
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Grant Number: I21HX001321-01
None at this time.