Clinical trial NCT00552578
Conditions: Opiate Addiction Refractory Pain
Keywords: drug dependence substance abuse substance use disorders myofascial pain syndrome neuralgia back pain
Sponsor: State University of New York at Buffalo
Start date: 2007-10-01; Completion date: 2008-10-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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).

Arms: arm 1: Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification. arm 2: Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
Interventions: intervention 1: buprenorphine/naloxone intervention 2: buprenorphine/naloxone
Intervention descriptions: intervention 1: sublingual tablets, 2/0.5 mg, three times a day for one month, twice a day for one month, once a day for one month, then every other day for one month. (dose may be adjusted based on an individual's response) intervention 2: sublingual tablets, 2/0.5 mg, one tablet three times a day for six months (doses may be adjusted based on an individual's response

Protocol documents: