Status:
RECRUITING
Better Options for Chronic Cancer Pain
Lead Sponsor:
VA Office of Research and Development
Conditions:
Chronic Pain
Cancer Survivor
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief Summary
This proposal is relevant to the 240,000 cancer survivors who continue to use opioids long after they have successfully completed treatment for cancer at the VHA, placing them at risk of opioid addict...
Detailed Description
Background: Twenty-four percent of Veterans who survive cancer remain on long term opioid therapy (LTOT) after completing cancer treatment, placing them at significant risk of opioid addiction, overdo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT06574009
Start Date
October 7 2025
End Date
December 31 2029
Last Update
November 3 2025
Active Locations (2)
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1
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
2
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105-2303