Phase 2
N=820
Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT03026790 ↗Enrolled (actual)
820
Serious AEs
30.2%
Results posted
Jun 2023
Primary outcome: Primary: Pain Response — 58; 54 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Medication management (Other); Non-pharmacological pain management (Other); Buprenorphine-Naloxone (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Response |
58; 54 | — |
| SECONDARY 50% Reduction in Opioid Daily Dose |
102; 98 | — |
| SECONDARY Composite Response |
17; 17 | — |
| SECONDARY Brief Pain Inventory (BPI) Total Score |
6.07; 6.01 | — |
Summary
Background and significance: Treatment with opioid pain medications (like hydrocodone and morphine) is common for severe pain, but studies show these medications may not always help and can cause serious problems. High daily doses of opioids can be especially unsafe. To help patients with chronic pain have better quality of life and avoid medication toxicity, health care teams need to manage pain while helping patients reduce opioid medication doses to safer levels.
Eligibility Criteria
Inclusion Criteria
- Moderate or high-dose long-term opioid therapy (≥ 20 ME mg daily for at least 3 months) for chronic pain
- Chronic pain of at least moderate severity (defined as pain that is present every or nearly every day for ≥ 6 months and with a score on the PEG 3-item pain measure of ≥ 5)
Exclusion Criteria
- Dementia diagnosis
- Unstable or severe untreated psychiatric disorder, including severe untreated substance use disorder or active suicidal ideation
- Unstable or end-stage medical disease that would interfere with participation, including cancer requiring active treatment and life expectancy < 12 months
- Documentation of suspected controlled substance diversion
- Inability to communicate by telephone
Data sourced from ClinicalTrials.gov (NCT03026790). 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.