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Completed Not applicable Interventional Results available

Integrated Services for Pain: Interventions to Reduce Pain Effectively

ClinicalTrials.gov ID: NCT03454555

Public ClinicalTrials.gov record NCT03454555. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 5:38 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Integrated Health Services to Reduce Opioid Use While Managing Chronic Pain

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03454555
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
RTI International
Other
Enrollment
543 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 25, 2019
Primary completion
Sep 29, 2023
Completion
Sep 29, 2023
Last update posted
Aug 11, 2025

2019 – 2023

United States locations

U.S. sites
3
U.S. states
2
U.S. cities
3
Facility City State ZIP Site status
University of North Carolina Health Care System Chapel Hill North Carolina 27599
Duke University Health System Durham North Carolina 27701
Vanderbilt University Medical Center Nashville Tennessee 27232

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03454555, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 11, 2025 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03454555 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →