Buprenorphine vs. Opioid Dose Escalation Among Patients With Chronic Pain

• Status: Terminated
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

Criteria

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