Actively Recruiting

Phase 4
Age: 18Years - 99Years
All Genders
Healthy Volunteers
NCT06574009

Better Options for Chronic Cancer Pain

Led by VA Office of Research and Development · Updated on 2026-05-11

294

Participants Needed

2

Research Sites

220 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 addiction and overdose, and other opioid-related problems. Yet, there are no programs at the VHA to help them find alternatives to opioids, nor evidence to inform the choice of interventions. This study will meet these needs by examining four interventions that are effective at reducing opioid use in patients with chronic musculoskeletal pain but have yet to be tested in cancer survivors on long term opioid therapy. The proposed work is relevant to the VHA Pain Office's mission to provide Veterans better pain management while limiting the risks of long-term opioid therapy and it aligns with VHA Research and Development's priority to examine clinical interventions for tapering opioids. Successful completion this project will keep VHA at the forefront of the battle against the opioid epidemic with a strategy that may be adapted to address the same needs in non-Veterans.

CONDITIONS

Official Title

Better Options for Chronic Cancer Pain

Who Can Participate

Age: 18Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 at least 6 months away from their last cytotoxic, radiation, or surgical cancer treatments but can be on hormonal or biologic therapies for remission or cancer control
  • Participants must report pain of 4 or higher on a 0-10 scale on their last 3 electronic medical record recordings
  • Veterans must be on Long Term Opioid Therapy (LTOT) defined as having a qualifying opioid dispensed within the prior 30 days plus at least 150 days' supply of qualifying opioids in the previous 180 days with no gaps over 40 days between fills
  • There must be advance agreement from their existing opioid prescriber to resume opioid prescribing after study
Not Eligible

You will not qualify if you...

  • Veterans with total daily opioid doses of 300 Morphine Milligram Equivalents (MME) or higher
  • Veterans with referrals or visits to a substance abuse clinic within the prior 2 years
  • Veterans with current or past use of buprenorphine
  • Veterans with active alcohol use disorder or substance use
  • Veterans at risk for opioid overdose such as active suicidality or history of self-directed violence
  • Veterans with daily use of benzodiazepines
  • Veterans who received opioids from non-VA providers in the prior 3 months
  • Veterans with aberrant urine drug screen at baseline (cannabis use is allowed)
  • Veterans meeting DSM criteria for opioid use disorder are not excluded if their only opioid source is the VA

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, United States, 46202-2884

Not Yet Recruiting

2

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States, 48105

Actively Recruiting

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Research Team

M

Maria J Silveira, MD MA MPH

CONTACT

M

Matthew D McCaa, MS OTR

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

6

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