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

Pain Med. 2025 Aug 1;26(8):477-489. doi: 10.1093/pm/pnaf049.

Abstract

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 International.

Keywords: chronic pain; cognitive behavioral therapy; opioids; shared decision making; tapering.

Publication types

  • Randomized Controlled Trial
  • Pragmatic Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Analgesics, Opioid* / administration & dosage
  • Analgesics, Opioid* / therapeutic use
  • Chronic Pain* / drug therapy
  • Chronic Pain* / psychology
  • Chronic Pain* / therapy
  • Cognitive Behavioral Therapy* / methods
  • Decision Making, Shared*
  • Drug Tapering*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Motivational Interviewing* / methods
  • Treatment Outcome

Substances

  • Analgesics, Opioid

Associated data

  • ClinicalTrials.gov/NCT03454555