- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01559454
Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients
A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Treatment in Opioid Dependent Chronic Back Pain Patients
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
New York
-
Amherst, New York, United States, 14228
- UB/MD Family Medicine, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- have a well-documented chronic pain disorder due to past back surgery,
- have a chronic back pain syndrome,
- have evidence of opioid addiction,
- prior attempt at abstinence-oriented treatment documented by the referring physician,
- be able to understand spoken and written English,
- reside in Erie or Niagara counties,
- have health insurance or other ability to pay for treatment with the approval from patient's primary physician;
- have no prior history of methadone or BUP/NLX maintenance treatment since the last surgery,
- not be a member of a vulnerable population, including prisoners
Exclusion Criteria:
- homeless, or any patient without a "locator" (no means to participate in the follow-up data collection interviews by phone),
- inability to give consent,
- those with major co-occurring psychiatric disorders,
- EKG showing prolonged QT and/or previous cardiac issues,
- are taking a medication that is contraindicated with methadone,
- medically unstable,
- urine positive for cocaine at initial visit,
- pregnant women
Study Plan
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:
|
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:
|
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
Investigators
- Study Director: Rachel A Rizzo, MPH, University at Buffalo
Publications and helpful links
General Publications
- Neumann AM, Blondell RD, Jaanimagi U, Giambrone AK, Homish GG, Lozano JR, Kowalik U, Azadfard M. A preliminary study comparing methadone and buprenorphine in patients with chronic pain and coexistent opioid addiction. J Addict Dis. 2013;32(1):68-78. doi: 10.1080/10550887.2012.759872.
- Nielsen S, Tse WC, Larance B. Opioid agonist treatment for people who are dependent on pharmaceutical opioids. Cochrane Database Syst Rev. 2022 Sep 5;9:CD011117. doi: 10.1002/14651858.CD011117.pub3. Review.
- Neumann AM, Blondell RD, Hoopsick RA, Homish GG. Randomized clinical trial comparing buprenorphine/naloxone and methadone for the treatment of patients with failed back surgery syndrome and opioid addiction. J Addict Dis. 2020 Jan-Mar;38(1):33-41. doi: 10.1080/10550887.2019.1690929. Epub 2019 Nov 27.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Back Pain
- Low Back Pain
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Respiratory System Agents
- Antitussive Agents
- Buprenorphine
- Naloxone
- Buprenorphine, Naloxone Drug Combination
- Methadone
Other Study ID Numbers
- FMD0600908A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Clinical Trials on Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
Ache Laboratorios Farmaceuticos S.A.Unknown
-
Palmer College of ChiropracticDepartment of Health and Human ServicesCompletedChronic Low Back Pain | Subacute Low Back PainUnited States
-
Universität Duisburg-EssenSiemens-BetriebskrankenkasseCompletedChronic Low Back Pain | Recurrent Low Back Pain
-
Karolinska InstitutetCompletedChronic Low Back Pain | Recurrent Low Back Pain | Persistent Low Back PainSweden
-
Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
Clinical Trials on Methadone
-
Pontificia Universidad Catolica de ChileCompletedPain, Postoperative | Opioid Use | Methadone Overdose of Undetermined IntentChile
-
Washington University School of MedicineCompleted
-
University of Southern DenmarkCompletedPain, Postoperative | Pain, Post Operative | Analgesics, Opioid | MethadoneDenmark
-
Washington University School of MedicineCompleted
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)RecruitingChronic Pain | Opioid Use Disorder | MethadoneUnited States
-
The Miriam HospitalUnknownOpioid-Related DisordersUnited States
-
Washington University School of MedicineCompleted
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)CompletedOpiate DependenceUnited States
-
University of VirginiaCompleted
-
Washington University School of MedicineNational Institute of Neurological Disorders and Stroke (NINDS)WithdrawnPolyneuropathy | HIV-associated NeuropathyUnited States