Buprenorphine as a Treatment in Opiate Dependent Pain Patients

University at Buffalo (UB)

Status and phase: Terminated; Phase 4

Conditions: Opiate Addiction; Refractory Pain

Treatments: Drug: buprenorphine/naloxone

Study type: Interventional

Funder types: Other

Identifiers

NCT00552578

FMD0400907A

Details and patient eligibility

About

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.

Full 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).

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Tapering doses of buprenorphine

Active Comparator group

Description:

Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.

Treatment:

Drug: buprenorphine/naloxone

Drug: buprenorphine/naloxone

Steady doses of buprenrophine

Experimental group

Description:

Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.

Treatment:

Drug: buprenorphine/naloxone

Drug: buprenorphine/naloxone