Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients

October 12, 2020 updated by: Richard Blondell, State University of New York at Buffalo

A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Treatment in Opioid Dependent Chronic Back Pain Patients

Chronic pain patients are treated with prescription opioids and many exhibit opioid addiction. Currently, there are no evidence-based guidelines to better manage patients with chronic pain and coexistent opioid addiction. This study compares 6-months buprenorphine and methadone treatment in these patients. The investigators hypothesize that both buprenorphine and methadone treatment will reduce pain and addiction behaviors and increase functioning in these patients.

Study Overview

Status

Completed

Conditions

Detailed Description

Chronic non-malignant pain (i.e. pain unrelated to cancer that persists beyond the usual course of disease or injury) is a major concern in the United States. Opioids are the most commonly prescribed medication to treat patients with chronic non-malignant pain. However, in one systematic review of chronic low back pain, the authors note that, although clinical trials suggest that opioids are effective for short-term use (≤ 16 weeks), the effectiveness of long-term opioids (> 16 weeks) for pain relief and improved physical functioning is less clear.

Five to 31 percent of chronic back pain patients prescribed long-term opioids show aberrant drug-taking behaviors. Many develop tolerance and withdrawal, 43% of these patients exhibit opioid addiction. Therefore, patients with chronic pain and a co-occurring opioid addiction present a clinical challenge. In such cases, referral to addiction experts is recommended, but specialized treatment is currently based on expert opinion and observational studies.

The expert recommendation is detoxification followed by treatment with methadone, buprenorphine, naltrexone, or non-opioid analgesics in conjunction with behavioral counseling. Discontinuing short-acting opioid medications increases pain and will make it difficult for these patients to abstain from opioids due to the severity of pain. However, continuing these opioid medications worsens their addiction and renders opioids ineffective in the treatment of pain. Research is needed to compare the various medication-assisted treatments.

Long-acting opioids (e.g., methadone, buprenorphine) are used to replace treatment with short-acting opioids (e.g., hydrocodone, oxycodone). Methadone is a full mu-opioid-receptor agonist that can be effective in treating pain. Two small studies suggest that treatment of patients with chronic pain and co-occurring substance use disorder with methadone and adjunctive pain management therapy is superior to non-opioid treatment protocols. Despite the demonstration that methadone can be effective as both an analgesic and for opioid addiction treatment, it possesses side effects (e.g, constipation) and serious adverse events (e.g, respiratory depression, risk of overdose) that limit its use, making physicians reluctant to prescribe methadone.

Buprenorphine, a partial opioid agonist, is an alternative to methadone for treatment of opioid addiction, has a safety profile superior to methadone, and possesses analgesic properties. For outpatient use, buprenorphine is combined with naloxone (BUP/NLX) to reduce the potential for abuse (i.e., IV administration). When given to those who abuse prescription opioids BUP/NLX possesses better treatment outcomes than those who abuse heroin. In one uncontrolled case series of 95 participants, Malinoff and his colleagues concluded that the effectiveness in the treatment of opioid dependence, in providing analgesia, and the low abuse liability make BUP/NLX a potentially useful treatment for patients with chronic pain and co-occurring opioid addiction. In a randomized controlled trial by Blondell et al. (2010), treatment with BUP/NLX was superior to the abstinence-oriented approach in regards to treatment retention in patients with chronic pain and co-existent opioid addiction. However, there has not been a randomized clinical trial comparing BUP/NLX with methadone maintenance in chronic pain patients with opioid addiction. Preliminary data suggest that both 6-months BUP/NLX and methadone treatment results analgesia, but methadone treatment results in better addiction outcomes. The present study is designed to determine the complexity of recovery outcomes (e.g., functioning, mental health) in chronic pain patients. Clinicians need evidence-based guidelines to more effectively manage patients who have both chronic pain and evidence of opioid misuse or addiction behaviors.

In this study, we plan to investigate whether patients treated with BUP/NLX and usual care will have improved clinical outcomes as those provided with methadone treatment and usual care. Specifically, we propose to give 63 patients BUP/NLX therapy for 6 months (experimental group) and 63 patients methadone therapy over 6 (active comparator). We hypothesize that patients given BUP/NLX treatment will have similar outcomes as those receiving methadone maintenance with respect to functioning, mental health, pain level, and treatment retention.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Amherst, New York, United States, 14228
        • UB/MD Family Medicine, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. have a well-documented chronic pain disorder due to past back surgery,
  2. have a chronic back pain syndrome,
  3. have evidence of opioid addiction,
  4. prior attempt at abstinence-oriented treatment documented by the referring physician,
  5. be able to understand spoken and written English,
  6. reside in Erie or Niagara counties,
  7. have health insurance or other ability to pay for treatment with the approval from patient's primary physician;
  8. have no prior history of methadone or BUP/NLX maintenance treatment since the last surgery,
  9. not be a member of a vulnerable population, including prisoners

Exclusion Criteria:

  1. homeless, or any patient without a "locator" (no means to participate in the follow-up data collection interviews by phone),
  2. inability to give consent,
  3. those with major co-occurring psychiatric disorders,
  4. EKG showing prolonged QT and/or previous cardiac issues,
  5. are taking a medication that is contraindicated with methadone,
  6. medically unstable,
  7. urine positive for cocaine at initial visit,
  8. pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Methadone
10-60 mg/day divided by 2-4 times a day
10-60 mg/day divided by 2-4 times a day for 6 months
Other Names:
  • Dolophine
Experimental: Buprenorphine/naloxone
4-16 mg/day divided by 2-4 times a day
4-16 mg/day divided by 2-4 times a day for 6 months
Other Names:
  • Suboxone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesia
Time Frame: 6 months
Pain severity will be measured using the Visual Analogue Scale (VAS) which has a range of 0-100 with 0 being no pain and 100 being worse possible pain.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Illicit Drug Use
Time Frame: 6 months
Illicit opioid use will be measured by self-report and confirmed with urine toxicology.
6 months
Cravings
Time Frame: at 6 months
Cravings will be assessed using the Visual Analogue Scale (VAS) with 0 being no cravings and 100 being worse possible cravings
at 6 months
Functioning
Time Frame: at 6 months
Functioning will be assessed using the Visual Analogue Scale (VAS) with 0 being "no limits" and 100 being "bedridden."
at 6 months
Depression
Time Frame: at 6 months
Depression will be assessed using the Beck Depression Inventory, a 63 point scale with 0 being "none" and 63 being "severe."
at 6 months
Treatment Retention
Time Frame: 6 months
Number of participants that completed the study protocol
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Rachel A Rizzo, MPH, University at Buffalo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

March 19, 2012

First Submitted That Met QC Criteria

March 20, 2012

First Posted (Estimate)

March 21, 2012

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

October 12, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

We are preparing a de-identified data set that could be shared.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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