Better Options for Chronic Cancer Pain
- NCT ID
- NCT06574009
- Registry status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Sponsor
- VA Office of Research and Development
- Conditions
- Cancer Survivor, Chronic Pain, Opioid Dependence
Overview
ClinicalTrials.gov lists this study as Recruiting.
Official title: Better Options for Chronic Cancer Pain: a SMART Study
Enrollment: 294 participants (Estimated).
What is being studied
- Device: Buprenorphine rotation
- Drug: Medication optimization
- Behavioral: Multimodal pain care
- Other: Opioid tapering
Who may be eligible
- Ages
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers accepted
- Yes
ClinicalTrials.gov lists the following eligibility criteria.
Inclusion Criteria:
* Veterans must have had a qualifying solid tumor (bladder, breast, colorectal, head and neck, liver, lung, pancreas, prostate, or urinary tract) without evidence of active disease for at least 6 months
* Participants must be 6 months away from their last receipt of cytotoxic, radiation, or surgical cancer treatments but can be on hormonal or biologic therapies needed to sustain remission or cancer control.
* Participants must report pain \>=4 (on 0-10 NRS) on their last 3 recordings in the electronic medical record. Veterans should be on Long Term Opioid Therapy (LTOT) defined as:
* a qualifying opioid analgesic dispensed within the prior 30 days
* plus 150 days' supply of a qualifying opioid (fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone) in the 180 days before the most recent dispensing date with no between-fill gaps \>40 days
* There must be advance agreement from their existing opioid prescriber to resume opioid prescribing after study
Exclusion Criteria:
* Veterans with total daily opioid doses \>= 300 Morphine Milligram Equivalents (MME) will be excluded (higher doses require tapering prior to rotation to buprenorphine, which is something the investigators do not want to examine in this study)
* Veterans with referrals or visits to a substance abuse clinic within the prior 2 years will be excluded to avoid including individuals requiring addiction expertise that is not available one the multidisciplinary pain teams
* The investigators will also exclude Veterans with:
* current or past use of buprenorphine
* active alcohol use disorder or substance use
* risk factors for opioid overdose (e.g. active suicidality or history of self-directed violence)
* daily use of benzodiazepines
* receipt of opioids from non-VA providers in the prior 3 months
* or aberrant urine drug screen at baseline (cannabis is not exclusionary)
* To ensure the relevance of our work to as many Veteran cancer survivors as possible, the investigators will not exclude subjects meeting DSM criteria for opioid use disorder if their only source of opioids is the VA
Study locations
2 study locations are listed.
Recruiting site status is explicitly provided for 2 locations; 1 is listed as Recruiting.
Countries: United States
- Indiana, United States: 1
- Michigan, United States: 1
Sample of listed locations
- VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, 48105, United States — Recruiting
- Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis, Indiana, 46202-2884, United States — Not yet recruiting
Study details
- Start date
- October 7, 2025
- Primary completion date
- April 1, 2029
- Completion date
- December 31, 2029
- First posted
- August 27, 2024
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT06574009
- Registry last updated
- May 11, 2026
- QualifiedStudies registry data refreshed
- October 2, 2026
- QualifiedStudies record fetched
- October 2, 2026
View NCT06574009 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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