Buprenorphine as a Treatment in Opiate Dependent Pain Patients
|ClinicalTrials.gov Identifier: NCT00552578|
Recruitment Status : Terminated ("Tapering doses" protocol arm was not effective for treatment retention outcome.)
First Posted : November 2, 2007
Results First Posted : July 7, 2009
Last Update Posted : February 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Opiate Addiction Refractory Pain||Drug: buprenorphine/naloxone||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial Testing Buprenorphine as a Treatment in Opiate Dependent Pain Patients|
|Study Start Date :||October 2007|
|Primary Completion Date :||October 2008|
|Study Completion Date :||October 2008|
Active Comparator: Tapering doses of buprenorphine
Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
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)
Other Name: Suboxone
Experimental: Steady doses of buprenrophine
Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
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
Other Name: Suboxone
- Relapse to Substance Abuse [ Time Frame: Six months ]Relapse to substance abuse (yes/no) was determined by participant self-report or by a positive urine toxicology.
- Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline. [ Time Frame: 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.
- Treatment Retention. [ Time Frame: Six months ]"Treatment retention" was defined as the completion of the buprenorphine dosing protocol (i.e., tapering doses vs. steady doses).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00552578
|United States, New York|
|Erie County Medical Center|
|Buffalo, New York, United States, 14215|
|Principal Investigator:||Richard D Blondell, MD||University at Buffalo|