Buprenorphine vs. Opioid Dose Escalation Among Patients With Chronic Pain
Condition: Pain
MeSH terms: Chronic Pain
Intervention: buprenorphine/naloxone; opioid dose escalation
Intervention description: partial opioid agonist; up to 25% increase in patient's current opioid dose
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pain management

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.
    

Eligibility 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