Recruiting

Opioid AlternativesBetter Options for Chronic Cancer Pain

Sponsor:

VA Office of Research and Development

Code:

NCT06574009

Conditions

Chronic Pain

Cancer Survivor

Opioid Dependence

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Multimodal pain care

Medication optimization

Buprenorphine rotation

Opioid tapering

Study Details

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 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

Chronic Pain

Cancer Survivor

Opioid Dependence

Study ID

NCT06574009

Start date

Oct 7, 2025

Status verified date

May, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Apr 1, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

294 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Multimodal pain care 9 months

Findings from the comprehensive pain assessment will be used to inform an individualized, multimodal plan crafted by the team physician with the subject's collaboration

experimental: Medication optimization

Findings from the comprehensive pain assessment will be used to inform a medication-focused pain plan.

experimental: Multimodal pain care 6 months / Opioid tapering 3 months

Findings from the comprehensive pain assessment will be used to inform an individualized, multimodal plan crafted by the team physician with the subject's collaboration. After 6 mo, subjects will attempt to taper opioids

experimental: Medication optimization 9 months

Findings from the comprehensive pain assessment will be used to inform a medication-focused pain plan. Medications will be optimized following an algorithm the investigators created based upon NCCN's Survivorship Guidelines and AHRQ's comprehensive review of non-opioid treatments for chronic pain.

experimental: Medication optimization 6 months/ Buprenorphine rotation 3 months

experimental: Medication optimization 6 months/ Opioid tapering 3 months

Interventions

Multimodal pain care

Behavioral therapy (as below), physical therapy, assistive devices (e.g. TENS, bracing), referrals to VA specialists (e.g. interventional pain), and complementary and integrative therapies (e.g. acupuncture or massage

Medication optimization

Medications will be optimized following an algorithm the investigators created based upon NCCN's Survivorship Guidelines and AHRQ's comprehensive review of non-opioid treatments for chronic pain.

Buprenorphine rotation

Subjects randomized to this arm at 6 months will be offered the chance to rotate from their full mu agonist opioid to buprenorphine using a standardized protocol

Opioid tapering

Subjects randomized to tapering will receive recommendations based upon the VA PBM's opioid tapering reference guide

Primary outcome measure

Opioid dose reduction + Pain response (binary: yes/no) [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Maria J Silveira, MD MA MPH

(734) 845-3502 Maria.Silveira2@va.gov

Matthew D McCaa, MS OTR

(650) 493-5000 matthew.mccaa@va.gov

Locations

VA Ann Arbor Healthcare System, Ann Arbor, MI

Recruiting

Ann Arbor, Michigan, United States, 48105

Contacts

Maria J Silveira, MD MA MPH

734-845-3502 Maria.Silveira2@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

May 11, 2026

Last verified

May, 2026

Keywords

survivorship
chronic pain
analgesics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-05-11.