What this study is
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.
What's being tested
- Multimodal pain care
Intervention · BEHAVIORAL
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
Intervention · DRUG
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
Intervention · DEVICE
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
Intervention · OTHER
Subjects randomized to tapering will receive recommendations based upon the VA PBM's opioid tapering reference guide
Study details
- Official title
- Better Options for Chronic Cancer Pain: a SMART Study
- Sponsor
- VA Office of Research and Development
- Conditions
- Chronic Pain · Cancer Survivor · Opioid Dependence
- Enrolling
- 294 people
- Starts
- 2025-10-07
- Est. completion
- 2029-12-31
- Design
- Open-label, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 99 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openRichard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States
- David Haggstrom, MD · Contactdahaggst@iu.edu
- Jasma Adams, BA · Contactjasma.adams2@va.gov
Not yet recruitingVA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
- Maria J Silveira, MD MA MPH · Contact734-845-3502Maria.Silveira2@va.gov
Recruiting
Study team
Sponsor
VA Office of Research and Development
Study ID NURP-004-24S
Principal investigator
Karleen F Giannitrapani, PhD MA MPH
VA Palo Alto Health Care System, Palo Alto, CA
Principal investigator
Maria J Silveira, MD MA MPH
VA Ann Arbor Healthcare System, Ann Arbor, MI
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.