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Behavioral Intervention
Better Options for Chronic Cancer Pain
N/A
Waitlist Available
Led By Maria J. Silveira, MD MA MPH
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to help cancer survivors who are still using opioids long after their cancer treatment. These survivors are at risk of opioid addiction and overdose. The study will look at four different ways to reduce opioid
Who is the study for?
This trial is for cancer survivors who have finished treatment but are still using opioids, potentially facing addiction or overdose risks. It's designed to help them find non-opioid pain relief alternatives.
What is being tested?
The study tests four strategies: multimodal pain care, reducing opioid doses gradually (tapering), switching from other opioids to buprenorphine (rotation), and optimizing medications to manage chronic cancer-related pain.
What are the potential side effects?
Possible side effects may include withdrawal symptoms due to opioid tapering, reactions to medication changes like buprenorphine rotation, and general discomfort that can come with adjusting pain management treatments.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I take less than 300mg of opioids daily.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Opioid dose reduction + Pain response (binary: yes/no)
Secondary study objectives
Opioid dose
Pain intensity
Pain interference
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Group I: Multimodal pain care 9 monthsExperimental Treatment1 Intervention
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
Group II: Multimodal pain care 6 months / Opioid tapering 3 monthsExperimental Treatment2 Interventions
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
Group III: Medication optimization 9 monthsExperimental Treatment1 Intervention
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.
Group IV: Medication optimization 6 months/ Buprenorphine rotation 3 monthsExperimental Treatment2 Interventions
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. After 6mo, subjects will receive buprenorphine and attempt to taper opioids for following 3 mo.
Group V: Medication optimization 6 mo/ Opioid tapering 3 monthsExperimental Treatment2 Interventions
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. After 6mo, subjects will attempt to taper opioids for following 3 mo.
Group VI: Medication optimizationExperimental Treatment2 Interventions
Findings from the comprehensive pain assessment will be used to inform a medication-focused pain plan.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,494 Total Patients Enrolled
Maria J. Silveira, MD MA MPHPrincipal InvestigatorVA Ann Arbor Healthcare System, Ann Arbor, MI
1 Previous Clinical Trials
134 Total Patients Enrolled
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