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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