Buprenorphine as a Treatment in Opiate Dependent Pain Patients

This study has been terminated.
("Tapering doses" protocol arm was not effective for treatment retention outcome.)
Sponsor:
Information provided by:
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT00552578
First received: November 1, 2007
Last updated: February 14, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Opiate Addiction
Refractory Pain
Drug: buprenorphine/naloxone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Testing Buprenorphine as a Treatment in Opiate Dependent Pain Patients

Resource links provided by NLM:


Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:
  • Relapse to Substance Abuse [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Relapse to substance abuse (yes/no) was determined by participant self-report or by a positive urine toxicology.


Secondary Outcome Measures:
  • Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline. [ Time Frame: Baseline and six months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    "Treatment retention" was defined as the completion of the buprenorphine dosing protocol (i.e., tapering doses vs. steady doses).


Enrollment: 12
Study Start Date: October 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tapering doses of buprenorphine
Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
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)
Other Name: Suboxone
Experimental: Steady doses of buprenrophine
Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
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
Other Name: Suboxone

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552578

Locations
United States, New York
Erie County Medical Center
Buffalo, New York, United States, 14215
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
Principal Investigator: Richard D Blondell, MD University at Buffalo
  More Information

Publications:
Responsible Party: Richard D. Blondell, SUNYBuffalo, Dept Family Medicine
ClinicalTrials.gov Identifier: NCT00552578     History of Changes
Other Study ID Numbers: FMD0400907A
Study First Received: November 1, 2007
Results First Received: January 21, 2009
Last Updated: February 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York at Buffalo:
drug dependence
substance abuse
substance use disorders
myofascial pain syndrome
neuralgia
back pain

Additional relevant MeSH terms:
Pain, Intractable
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Buprenorphine
Naloxone
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014