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N/A N=525 Randomized Treatment

Integrated Services for Pain: Interventions to Reduce Pain Effectively

Chronic Pain

Enrolled (actual)
525
Serious AEs
7.2%
Results posted
Aug 2025
Primary outcome: Primary: Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 12 — -11.6; -6.0 Morphine Milligram Equivalents (MME) — p=0.31

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Shared Decision Making (Behavioral); Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
RTI International
Primary completion
Sep 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 12
-11.6; -6.0 0.31
PRIMARY
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 3
0.0; -0.3 0.963
PRIMARY
Change From Baseline in Average Daily Opioid Dose in in Morphine Milligram Equivalents (MME) at Month 6
-5.9; 0.3 0.253
PRIMARY
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 9
-6.6; -7.3 0.90
PRIMARY
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 15
-9.4; -6.8 0.65
PRIMARY
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 18
-3.1; -12.5 0.102
PRIMARY
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 12
0.29; 0.30 0.83
PRIMARY
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 3
0.13; 0.16 0.47
PRIMARY
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 6
0.21; 0.21 0.96
PRIMARY
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 9
0.22; 0.28 0.28
PRIMARY
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 15
0.30; 0.32 0.75
PRIMARY
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 18
0.26; 0.35 0.25
SECONDARY
Change From Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 6
0.5; 0.3 0.70
SECONDARY
Change From Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 12
0.1; 0.0 0.92
SECONDARY
Change From Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 6
-0.4; -0.6 0.64
SECONDARY
Change From Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 12
-0.3; -0.5 0.75

Summary

Long-term pain -or pain that lasts for months or years-is one of the most common health problems in the United States. Clinicians often prescribe opioids which can help ease pain in the short term, but evidence does not support their effectiveness over the long term. For some people, long-term opioid use can lead to addiction and overdose. People need effective options and support to help maintain or improve their function and quality of life. This study compared two programs for helping people living with long-term pain who have been prescribed opioids for 3 or more months. This study was done at primary care and pain care clinics at 3 health systems in the Southeastern United States. The study team assigned people by chance to one of two study programs: (1) individual motivational interviewing plus group-based cognitive behavioral therapy (MI+CBT) or (2) patient-clinician shared decision making. In the MI+CBT program, the patient learned strategies to better cope with chronic pain. In the SDM program, the patient and clinician worked together through enhanced communication to make decisions that aligned with values and preferences of the patient. The study team compared the two programs by looking at changes in opioid dosage, physical functioning, and pain interference over time. They collected information about prescribed opioid dosage from electronic health records and patients completed surveys at the start of the study and 6 and 12 months later. The study team worked with an advisory group that included patients, advocates, clinicians, and pain experts. The advisory group met with the study team two to three times per year to provide input on the study.

Eligibility Criteria

Inclusion Criteria

  • Aged 18 to 85 years
  • History of chronic non-cancer pain (CNCP)
  • Receiving chronic opioid therapy for CNCP as evidenced by current or most recent prescription of an average daily prescribed dosage of 20 milligrams of morphine equivalents
  • Receiving care at a participating clinic from a participating provider, as evidenced by at least 1 in-person visit within the past 12 months.

Exclusion Criteria

  • Not meeting the above inclusion criteria
  • Opioid use is for pain directly related to an active cancer diagnosis
  • Opioid use is for maintenance treatment of an opioid use disorder
  • Suicide attempt within the past 3 years
  • Active suicidal ideation
  • Currently receiving Cognitive-Behavioral Therapy (CBT)
  • Non-English speaking
  • Other reason at the discretion of the investigator
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03454555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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