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Buprenorphine vs. Opioid Dose Escalation Among Patients With Chronic Pain

TerminatedPhase 4NCT01875848
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Buprenorphine vs. Opioid Dose Escalation Among Patients With Chronic Pain
Conditions
Interventions
  • Drug: buprenorphine/naloxone
  • Drug: opioid dose escalation
Sponsor
VA Office of Research and Development
Start date
2013-12
Primary completion
2015-06
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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. Inclusion Criteria: * 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 Criteria: * 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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01875848