Buprenorphine as a Treatment in Opiate Dependent Pain Patients

NCT ID: NCT00552578

Last Updated: 2011-02-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-10-31

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).

Conditions

Opiate Addiction; Refractory Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tapering doses of buprenorphine

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

Group Type: ACTIVE_COMPARATOR

buprenorphine/naloxone

Intervention Type: DRUG

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)

Steady doses of buprenrophine

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

Group Type: EXPERIMENTAL

buprenorphine/naloxone

Intervention Type: DRUG

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

Interventions

buprenorphine/naloxone

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 Type: DRUG

buprenorphine/naloxone

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

Intervention Type: DRUG

Other Intervention Names

Suboxone; Suboxone

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

SUNYBuffalo, Dept Family Medicine

Principal Investigators

Richard D Blondell, MD

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo

Locations

Erie County Medical Center

Buffalo, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20959867 (View on PubMed)

Other Identifiers

FMD0400907A

Identifier Type: -

Identifier Source: org_study_id