Better Options for Chronic Cancer Pain
- Conditions
- Chronic PainCancer SurvivorOpioid Dependence
- Registration Number
- NCT06574009
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 294
Inclusion Criteria:<br><br> - Veterans must have had a qualifying solid tumor (bladder, breast, colorectal, head<br> and neck, liver, lung, pancreas, prostate, or urinary tract) without evidence of<br> active disease for at least 6 months<br><br> - Participants must be 6 months away from their last receipt of cytotoxic, radiation,<br> or surgical cancer treatments but can be on hormonal or biologic therapies needed to<br> sustain remission or cancer control.<br><br> - Participants must report pain >=4 (on 0-10 NRS) on their last 3 recordings in the<br> electronic medical record. Veterans should be on Long Term Opioid Therapy (LTOT)<br> defined as:<br><br> - a qualifying opioid analgesic dispensed within the prior 30 days<br><br> - plus 150 days' supply of a qualifying opioid (fentanyl, hydrocodone,<br> hydromorphone, methadone, morphine, oxycodone, oxymorphone) in the 180 days<br> before the most recent dispensing date with no between-fill gaps >40 days<br><br> - There must be advance agreement from their existing opioid prescriber to resume<br> opioid prescribing after study<br><br>Exclusion Criteria:<br><br> - Veterans with total daily opioid doses >= 300 Morphine Milligram Equivalents (MME)<br> will be excluded (higher doses require tapering prior to rotation to buprenorphine,<br> which is something the investigators do not want to examine in this study)<br><br> - Veterans with referrals or visits to a substance abuse clinic within the prior 2<br> years will be excluded to avoid including individuals requiring addiction expertise<br> that is not available one the multidisciplinary pain teams<br><br> - The investigators will also exclude Veterans with:<br><br> - current or past use of buprenorphine<br><br> - active alcohol use disorder or substance use<br><br> - risk factors for opioid overdose (e.g. active suicidality or history of<br> self-directed violence)<br><br> - daily use of benzodiazepines<br><br> - receipt of opioids from non-VA providers in the prior 3 months<br><br> - or aberrant urine drug screen at baseline (cannabis is not exclusionary)<br><br> - To ensure the relevance of our work to as many Veteran cancer survivors as possible,<br> the investigators will not exclude subjects meeting DSM criteria for opioid use<br> disorder if their only source of opioids is the VA
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Opioid dose reduction + Pain response (binary: yes/no)
- Secondary Outcome Measures
Name Time Method Opioid dose;Pain interference;Pain intensity