Buprenorphine vs. Opioid Dose Escalation Among Patients With Chronic Pain

Stopped early · Phase 4

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT01875848

Run by

VA Office of Research and Development

People needed

7

Starts

2013-12-01

Expected to finish

2015-06-01

Last updated by the study team

2016-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven, Connecticut, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.