Buprenorphine as a Treatment in Opiate Dependent Pain Patients

Phase 4

Terminated

Conditions: Refractory Pain
Opiate Addiction

Interventions: Drug: buprenorphine/naloxone

Registration Number: NCT00552578

Lead Sponsor: State University of New York at Buffalo

Brief Summary: 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.

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, which included the completion of the study buprenorphine treatment protocols.

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).

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 12

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tapering doses of buprenorphine	buprenorphine/naloxone	Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
Steady doses of buprenrophine	buprenorphine/naloxone	Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.

Primary Outcome Measures

Name	Time	Method
Relapse to Substance Abuse	Six months	Relapse to substance abuse (yes/no) was determined by participant self-report or by a positive urine toxicology.

Secondary Outcome Measures

Name	Time	Method
Treatment Retention.	Six months	"Treatment retention" was defined as the completion of the buprenorphine dosing protocol (i.e., tapering doses vs. steady doses).
Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline.	Baseline and six months	Qualitative measure (better/no change/worse) of participant's perception of overall quality of life related to assigned study protocol arm.