Buprenorphine as a Treatment in Opiate Dependent Pain Patients

Condition(s) targeted: Opiate Addiction; Refractory Pain

Intervention: buprenorphine/naloxone (Drug); buprenorphine/naloxone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: State University of New York at Buffalo

Official(s) and/or principal investigator(s):
Richard D Blondell, MD, Principal Investigator, Affiliation: University at Buffalo

Overall contact:
Richard D Blondell, MD, Phone: 716-898-4971, Email: blondell@buffalo.edu

This study is designed to determine if different doses of buprenorphine (either tapering doses or maintenance doses) are effective in managing chronic, non-cancer pain in individuals who also are addicted to opiate pain medicines.

Official title: A Randomized Controlled Trail Testing Buprenorphine as a Treatment in Opiate Dependent Pain Patients

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Relapse to substance abuse

Secondary outcome:

Quality of life measurement

Treatment retention

Detailed description: Context: Some individuals have two conditions: 1) a well-documented pain disorder and 2) clear evidence of a substance use disorder with opiate dependency. It is not known how to manage these patients. In addition to other modalities for the treatment of chronic pain, combination tablets of buprenorphine/naloxone (Suboxone) may be helpful.

Objective: The objective of this study is to determine if the addition of pharmacotherapy with Suboxone to usual care would improve clinical outcome relative to usual care alone.

Design: Randomized control trial.

Setting: The study will be conducted in the out-patient clinics of a tertiary-care teaching hospital.

Participants: The participants will be those who have: 1) a well-documented pain disorder and 2) clear evidence of a substance use disorder with opiate dependency.

Baseline data collected: Data collected at baseline will include (with examples): demographics (age, gender, race), substance use history (type of substances used, duration of use, routes of abuse), type of pain disorder (previous traumatic injury, musculoskeletal, neuropathic), co-existing medical problems (seizures, hepatitis C), prior injuries (accidents, interpersonal violence), prior mental health problems (prior treatment, diagnoses), prior substance abuse treatment (outpatient, inpatient), socioeconomic variables (educational level, occupation, employment history), criminal history (number of arrests and convictions, total amount of time spent in jail or prison), family history (first degree relatives with substance use disorders) and scores on psychometric testing (ASI).

Outcome data: Three main outcome variables will be examined relapse to substance use (as documented by toxicology), quality of life, and successful participation in the pain management program for six months.

Data analyses: Outcome variables will be compared between the two groups using t-tests or chi-square tests as appropriate. A Kaplan-Myer survival analysis will be used to describe participant participation. Predictors of poor outcomes will be identified using a case-control design in which those with poor outcomes (the "cases") will be compared to those with successful outcomes (the "controls") using multivariate techniques (logistic regression).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Clinical diagnosis of chronic refractory pain

- Clinical diagnosis of opiate dependency

Exclusion Criteria:

- unable to pay for medication

- enrolled in a methadone maintenance program

- homelessness

- major mental illness

- pregnant women

- prisoners

- terminal cancer pain

Richard D Blondell, MD, Phone: 716-898-4971, Email: blondell@buffalo.edu

Erie County Medical Center, Buffalo, New York 14215, United States; Recruiting
Richard D Blondell, MD, Phone: 716-898-4971, Email: blondell@buffalo.edu
Daniel Salcedo, MD, Phone: 716-898-4995, Email: DSalcedo@ecmc.edu
Richard D Blondell, MD, Principal Investigator
Daniel Salcedo, MD, Sub-Investigator

Starting date: October 2007
Ending date: June 2008
Last updated: December 5, 2007