Effectiveness of motivational interviewing plus cognitive behavioral therapy vs shared decision making for voluntary opioid tapering in patients with chronic pain: the INSPIRE randomized pragmatic trial

Objective To compare the effectiveness of motivational interviewing plus cognitive behavioral therapy vs shared decision making on change in daily dosage of prescribed opioids for individuals with chronic non-cancer pain.Design Pragmatic randomized trial.Setting Three health systems in the southeastern United States.Subjects Adults (N = 525) prescribed opioid therapy for chronic non-cancer pain.Methods Participants were randomized to Arm 1 (a motivational interviewing visit plus eight group sessions of cognitive behavioral therapy) or Arm 2 (shared decision making medical visits). The primary outcome was change in average daily opioid dosage from baseline to 12 months using prescribing data from health records. Secondary outcomes were self-reported pain interference and physical function.Results Both arms experienced small decreases in dosage at 12 months from baseline: Arm 1 -12 milligram morphine equivalents (95% confidence interval: -19 to -4); Arm 2 - 6 milligram morphine equivalents (95% confidence interval: -14 to 2). The mean difference between arms for change in dosage, at -6 milligram morphine equivalents (95% confidence interval: -17 to 5), was neither statistically significant nor clinically meaningful. Those in Arm 1 with a mental health diagnosis had a larger reduction in dosage (-22 milligram morphine equivalents, 95% confidence interval: -33 to -11) than those in Arm 1 without a mental health diagnosis and those in Arm 2 with a mental health diagnosis (interaction P = .10). No change from baseline occurred in pain interference or physical function for either arm.Conclusions Additional strategies are needed to support individuals prescribed opioid therapy for chronic pain with pain management and dosage reduction. Clinicaltrials.gov registration: NCT03454555. Participant enrollment began on June 26, 2019. https://classic.clinicaltrials.gov/ct2/show/NCT.03454555. Trial sponsor: RTI InternationalConclusions Additional strategies are needed to support individuals prescribed opioid therapy for chronic pain with pain management and dosage reduction. Clinicaltrials.gov registration: NCT03454555. Participant enrollment began on June 26, 2019. https://classic.clinicaltrials.gov/ct2/show/NCT.03454555. Trial sponsor: RTI InternationalConclusions Additional strategies are needed to support individuals prescribed opioid therapy for chronic pain with pain management and dosage reduction. Clinicaltrials.gov registration: NCT03454555. Participant enrollment began on June 26, 2019. https://classic.clinicaltrials.gov/ct2/show/NCT.03454555. Trial sponsor: RTI International