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.
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2025-08
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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.Type
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McCormack, Lauren A, Mark J Edlund, Sonia M Thomas, Li-Tzy Wu, Paul R Chelminski, Kristin R Archer, Laura K Wagner, Shawn Hirsch, et al. (2025). 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 medicine (Malden, Mass.), 26(8). pp. 477–489. 10.1093/pm/pnaf049 Retrieved from https://hdl.handle.net/10161/33188.
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Scholars@Duke
Li-Tzy Wu
Education/Training: Pre- and post-doctoral training in mental health service research, psychiatric epidemiology (NIMH T32), and addiction epidemiology (NIDA T32) from Johns Hopkins University School of Public Health (Maryland); Fellow of the NIH Summer Institute on the Design and Conduct of Randomized Clinical Trials.
Director: Duke Community Based Substance Use Disorder Research Program.
Research interests: COVID-19, Opioid misuse, Opioid overdose, Opioid use disorder, Opioid addiction prevention and treatment, Pain and addiction, Chronic diseases and substance use disorders, diabetes, pharmacy-based care models and services, medication treatment for opioid use disorder (MOUD), Drug overdose, Polysubstance use and disorders, cannabis, alcohol, tobacco, hallucinogens, stimulants, e-cigarette, SBIRT (substance use Screening, Brief Intervention, Referral to Treatment), EHR-based research and intervention, data science, psychometric analysis (IRT), epidemiology of addictions and comorbidity, behavioral health care integration, health services research (mental health disorders, substance use disorders, chronic diseases), nosology, research design, HIV risk behavior.
FUNDED Research projects (Principal Investigator [PI], Site PI, or Sub-award PI):
R03: Substance use/dependence (PI).
R21: Treatment use for alcohol use disorders (PI).
R21: Inhalant use & disorders (PI).
R01: MDMA/hallucinogen use/disorders (PI).
R01: Prescription pain reliever (opioids) misuse and use disorders (PI).
R01: Substance use disorders in adolescents (PI).
R21: CTN Substance use diagnoses & treatment (PI).
R33: CTN Substance use diagnoses & treatment (PI).
R01: Evolution of Psychopathology in the Population (ECA Duke site PI).
R01: Substance use disorders and treatment use among Asian Americans and Pacific Islanders (PI).
UG1: SBIRT in Primary Care (NIDA, PI).
UG1: TAPS Tool, Substance use screening tool validation in primary care (NIDA, PI).
UG1: NIDA CTN Mid-Southern Node (Clinical Trials Network, PI).
UG1: EHR Data Element Study (NIDA, PI).
UG1: Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder (NIDA, PI).
PCORI: INSPIRE-Integrated Health Services to Reduce Opioid Use While Managing Chronic Pain (Site PI).
CDC R01: Evaluation of state-mandated acute and post-surgical pain-specific CDC opioid prescribing (Site PI).
Pilot: Measuring Opioid Use Disorders in Secondary Electronic Health Records Data (Carolinas Collaborative Grant: Duke PI).
R21: Developing a prevention model of alcohol use disorder for Pacific Islander young adults (Subaward PI, Investigator).
UG1: Subthreshold Opioid Use Disorder Prevention Trial (NIH HEAL Initiative) (NIDA supplement, CTN-0101, Investigator).
NIDA: A Pilot Study to Permit Opioid Treatment Program Physicians to Prescribe Methadone through Community Pharmacies for their Stable Methadone Patients (NIDA/FRI: Study PI).
UG1: Integrating pharmacy-based prevention and treatment of opioid and other substance use disorders: A survey of pharmacists and stakeholder (NIH HEAL Initiative, NIDA, PI).
UG1: NorthStar Node of the Clinical Trials Network (NIDA, Site PI).
R34: Intervention Development and Pilot Study to Reduce Untreated Native Hawaiian and Pacific Islander Opioid Use Disorders (Subaward PI, Investigator).
UG1: Optimal Policies to Improve Methadone Maintenance Adherence Longterm (OPTIMMAL Study) (NIDA, Site PI).
R01: Increasing access to opioid use disorder treatment by opening pharmacy-based medication units of opioid treatment programs (NIDA, PI)
R01: Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults (Subaward PI, Investigator).
R01: Understanding the short- and long-term effects of the COVID-19 pandemic on the overdose crisis (Subaward PI, Investigator).
UG1: Northstar Node of The Clinical Trials Network (Subaward PI, Investigator).
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