Design of a multicenter randomized controlled trial comparing the effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for voluntary opioid tapering: The INSPIRE study protocol

Lauren A. McCormack; Mark James Edlund; Jessica Elizabeth Thompson; Laura Kay Wagner; Li-Tzy Wu; Sonia Marie Thomas; Mark James Edlund; Sonia Thomas; Laura Kay Wagner; Jessica Thompson DeFrank; Li-Tzy Wu; Rowena J Dolor; Paul R. Chelminski; Timothy J Ives; Kristin R Archer; Charlene M Dewey; Mark D Sullivan; Lauren A. McCormack

Design of a multicenter randomized controlled trial comparing the effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for voluntary opioid tapering

The INSPIRE study protocol

Edlund, M. J., Thomas, S. M., Wagner, L. K., Thompson, J., Wu, L.-T., Dolor, R. J., Chelminski, P. R., Ives, T. J., Archer, K. R., Dewey, C. M., Sullivan, M. D., McCormack, L. A., & INSPIRE Study Team (2024). Design of a multicenter randomized controlled trial comparing the effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for voluntary opioid tapering: The INSPIRE study protocol. Contemporary Clinical Trials, 137, 107410. Article 107410. https://doi.org/10.1016/j.cct.2023.107410

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Abstract

BACKGROUND: This paper describes the design and protocol of a pragmatic, randomized trial to evaluate the comparative effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for chronic pain for the voluntary tapering of opioid dose in adults with chronic noncancer pain. Integrated Services for Pain: Interventions to Reduce Pain Effectively (INSPIRE) is a multicenter, randomized trial conducted at three academic health centers in the southeastern United States. Participants are adults receiving long-term opioid therapy of at least 20 morphine milligram equivalents daily for chronic noncancer pain.

METHODS: Participants were randomized to either the shared decision-making intervention or the motivational interviewing session and cognitive behavioral therapy for chronic pain intervention. All participants also received guideline-concordant care supporting opioid pharmacotherapy. The primary outcome was change from baseline in average daily prescribed opioid dose at 12 months, using prescribing data from electronic health records. Secondary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference and Physical Function at 12 months.

CONCLUSION: This trial evaluates the comparative effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for chronic pain for the voluntary tapering of opioid dose in adults with chronic noncancer pain. Results from this study can guide clinicians, researchers, and policymakers as they seek to reduce opioid prescribing and improve management of chronic pain.

CLINICAL TRIAL REGISTRATION NUMBER: NCT03454555.

CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT03454555 (https://clinicaltrials.gov/ct2/show/record/NCT03454555). Participant enrollment began on June 26, 2019.