Buprenorphine vs. Opioid Dose Escalation Among Patients With Chronic Pain

NCT01875848 | Terminated Phase 4 Results DMC

• 1 other identifier: PPO 13-184
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

pain management

Outcome Measures

Primary Outcomes (1)

• Change in Numeric Rating Scale of Pain Severity

  Validated 11 pt scale 0-10, to evaluate a patient's current severity of pain. A rating of 0 indicates no pain while 10 indicates the worst pain imaginable. A score of 4 or above is considered a clinically significant pain level according to VHA treatment guidelines.

  Baseline and 12 wks

Secondary Outcomes (1)

• Patient Global Impression of Change (PGIC)

  12 wks

Study Arms (2)

buprenorphine/naloxone

EXPERIMENTAL

induction onto buprenorphine/naloxone from opioid treatment

Drug: buprenorphine/naloxone

opioid dose escalation

ACTIVE COMPARATOR

increase of up to 25% of current opioid dose

Drug: opioid dose escalation

Interventions

buprenorphine/naloxone DRUG

partial opioid agonist

Also known as: Suboxone

buprenorphine/naloxone

opioid dose escalation DRUG

up to 25% increase in patient's current opioid dose

Also known as: No other names

opioid dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 and older
• months of continuous opioid therapy for chronic pain;
• mg morphine equivalent daily opioid dose based on pharmacy records of standing and as needed opioids prescribed.
• (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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

Aim 1 of the study was achieved: we found that despite moderate to high levels of pain interference, only a small proportion of eligible patients entered the trial. For this reason, the data \& safety monitoring board recommended early termination.

Results Point of Contact

• Title: William, Becker M.D
• Organization: VACT West Haven HealthCare System

william.becker4@va.gov

203-932-5711

Study Officials

• William C Becker, MD

  VA Connecticut Healthcare System West Haven Campus, West Haven, CT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: June 12, 2013
• Study Start: December 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 21, 2016
• Results First Posted: December 21, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)