MedPath

Better Options for Chronic Cancer Pain

Not Applicable
Not yet recruiting
Conditions
Chronic Pain
Cancer Survivor
Opioid 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

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

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Opioid dose reduction + Pain response (binary: yes/no)
Secondary Outcome Measures
NameTimeMethod
Opioid dose;Pain interference;Pain intensity
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