Safer pain treatment options for cancer survivors on long-term opioids

Better Options for Chronic Cancer Pain: a SMART Study

This project will try four different approaches to lower long-term opioid use while keeping pain controlled in Veterans who are cancer survivors on chronic opioid therapy.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 294 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: VA Office of Research and Development (fed)
• Drugs / interventions: radiation
• Locations: 2 sites (Indianapolis, Indiana and 1 other locations)
• Trial ID: NCT06574009 on ClinicalTrials.gov

What this trial studies

This Phase 4 interventional trial will assign Veterans who are cancer survivors on long-term opioid therapy to one of four treatment strategies: multimodal pain care, medication optimization, buprenorphine rotation, or opioid tapering. The primary goal is to see which strategy or combination best reduces opioid use without worsening chronic pain over 6 and 9 months. Investigators will measure opioid dispensing and pain scores from electronic health records and collect implementation data on barriers and facilitators to delivering each approach within the VA. The project aims to produce practical care pathways that can be adopted across VA clinics to reduce opioid-related harms in this population.

Who should consider this trial

Good fit: Ideal candidates are Veterans who completed curative treatment for a qualifying solid tumor at least six months ago, report pain ≥4 on recent records, are on long-term opioid therapy as defined by the protocol, and have agreement from their current opioid prescriber.

Not a fit: Patients with active cancer, those not on long-term opioid therapy, those unwilling to change medications or attend VA sites, or patients with medical contraindications to buprenorphine may not benefit from or be eligible for these interventions.

Why it matters

Potential benefit: If successful, this work could reduce long-term opioid exposure and related overdose or addiction risk while providing VA clinics clear care pathways for managing chronic pain in cancer survivors.

How similar studies have performed: Multimodal pain programs and buprenorphine rotation have reduced opioid use in Veterans with musculoskeletal pain, but these approaches have not yet been tested specifically in cancer survivors on long-term opioids.

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

Where this trial is running

Indianapolis, Indiana and 1 other locations

• Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis, Indiana, United States (NOT_YET_RECRUITING)
• VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States (RECRUITING)

Study contacts

• Principal investigator: Karleen F Giannitrapani, PhD MA MPH — VA Palo Alto Health Care System, Palo Alto, CA
• Study coordinator: Maria J Silveira, MD MA MPH

Conditions: Chronic Pain, Cancer Survivor, Opioid Dependence, survivorship, chronic pain, analgesics