Clinical trial NCT00552578: Buprenorphine as a Treatment in Opiate Dependent Pain Patients
Official title: A Randomized Controlled Trial Testing Buprenorphine as a Treatment in Opiate Dependent Pain Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Opiate Addiction
Refractory Pain
Keywords: drug dependence
substance abuse
substance use disorders
myofascial pain syndrome
neuralgia
back pain
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2007-11-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Relapse to Substance Abuse
timeFrame: Six months
Secondary outcomes:
measure: Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline.
timeFrame: Baseline and six months
measure: Treatment Retention.
timeFrame: Six months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
Study officials:
affiliation: University at Buffalo
name: Richard D Blondell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blondell RD, Ashrafioun L, Dambra CM, Foschio EM, Zielinski AL, Salcedo DM. A Clinical Trial Comparing Tapering Doses of Buprenorphine with Steady Doses for Chronic Pain and Co-existent Opioid Addiction. J Addict Med. 2010 Sep;4(3):140-6. doi: 10.1097/ADM.0b013e3181ba895d.