Buprenorphine as a Treatment in Opiate Dependent Pain Patients

Opiate Addiction Clinical Trial

Official title:

A Randomized Controlled Trial Testing Buprenorphine as a Treatment in Opiate Dependent Pain Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00552578
• Other study ID #: FMD0400907A
• Status: Terminated
• Phase: Phase 4
• First received: November 1, 2007
• Last updated: February 14, 2011
• Start date: October 2007
• Est. completion date: October 2008

Study information

• Verified date: February 2011
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opiate Addiction
• Pain, Intractable
• Refractory Pain

Intervention

Drug:
• 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)
• 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

Locations

Country	Name	City	State
United States	Erie County Medical Center	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse to Substance Abuse	Relapse to substance abuse (yes/no) was determined by participant self-report or by a positive urine toxicology.	Six months	No
Secondary	Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline.	Qualitative measure (better/no change/worse) of participant's perception of overall quality of life related to assigned study protocol arm.	Baseline and six months	No
Secondary	Treatment Retention.	"Treatment retention" was defined as the completion of the buprenorphine dosing protocol (i.e., tapering doses vs. steady doses).	Six months	No