This study is designed to determine if different doses of buprenorphine (either tapering
doses or steady doses) are effective in managing chronic, non-cancer pain in individuals who
also are addicted to opiate pain medicines.
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
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
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, which included the completion of the study buprenorphine
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
- Clinical diagnosis of chronic refractory pain
- Clinical diagnosis of opiate dependency
- unable to pay for medication
- enrolled in a methadone maintenance program
- major mental illness
- pregnant women
- terminal cancer pain