Status:
TERMINATED
Buprenorphine vs. Opioid Dose Escalation Among Patients With Chronic Pain
Lead Sponsor:
VA Office of Research and Development
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study compares buprenorphine/naloxone to opioid dose escalation among patients with poorly controlled non-cancer pain on 30-100 mg daily morphine equivalent opioid dose.
Detailed Description
Increasingly, Veterans are prescribed potent opioid analgesics for the treatment of chronic pain despite limited evidence for efficacy and increasing evidence of serious harms including addiction and ...
Eligibility Criteria
Inclusion
- Participants were recruited and enrolled at VACT West Haven, CT. Participants are aged 18 and older and have 3 months or more of continuous opioid therapy for chronic pain. Participants are actively prescribed 30-100mg of morphine equivalent opioid dose based on pharmacy records. Primary Care Providers will assent for patient participation.
- Aged 18 and older
- 3 months of continuous opioid therapy for chronic pain;
- 30-100 mg morphine equivalent daily opioid dose based on pharmacy records of standing and as needed opioids prescribed.
- 28 (out of 70) on the 7-item Brief Pain Inventory (BPI) functional interference subscale at screening
- Numerical pain rating of 4 or greater (i.e., moderate pain or greater) at screening on the 11-point pain numerical rating scale (NRS)
- Females must (a) be using birth control pills or depo provera injections, or have an intrauterine device; or (b) be post-menopausal, or (c) have undergone surgically sterilization.
- Primary care provider's (PCP) assent for patient participation, ascertained via encrypted email or in-person query.
Exclusion
- DSM-IV defined substance use disorder, except nicotine dependence. Participants known to using marijuana, including those who are apparently legally authorized to use marijuana by non-VHA providers, will be excluded since opioid dose escalation in regular marijuana users is contraindicated.
- Opioid therapy for palliative care
- Participation in another investigational pharmaceutical trial within 30 days of screening
- Pregnancy or lactation
- Recently decompensated medical illness necessitating inpatient hospitalization (past 30 days)
- Transaminases (aspartate aminotransferase/alanine aminotransferase) greater than five times the upper limit of normal within 90 days of assessment phase
- Not well-controlled psychiatric symptoms at the time of physician assessment, including suicidal ideation or untreated psychosis; or recently decompensated psychiatric illness necessitating inpatient hospitalization (past 30 days).
- Use of a moderate to strong CYP3A4 inhibitor
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01875848
Start Date
December 1 2013
End Date
June 1 2015
Last Update
December 21 2016
Active Locations (1)
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1
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516