Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Drug: Methadone; Drug: Buprenorphine/naloxone	Phase 4

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	19 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Treatment in Opioid Dependent Chronic Back Pain Patients
Study Start Date :	February 2012
Actual Primary Completion Date :	May 2014
Actual Study Completion Date :	May 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Methadone; 10-60 mg/day divided by 2-4 times a day	Drug: Methadone; 10-60 mg/day divided by 2-4 times a day for 6 months; Other Name: Dolophine
Experimental: Buprenorphine/naloxone; 4-16 mg/day divided by 2-4 times a day	Drug: Buprenorphine/naloxone; 4-16 mg/day divided by 2-4 times a day for 6 months; Other Name: Suboxone

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Illicit Drug Use [ Time Frame: 6 months ]
   Illicit opioid use will be measured by self-report and confirmed with urine toxicology.
2. 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
3. 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."
4. 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."
5. Treatment Retention [ Time Frame: 6 months ]
   Number of participants that completed the study protocol

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

State University of New York at Buffalo

Investigators

Study Director:	Rachel A Rizzo, MPH	University at Buffalo

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Neumann AM, Blondell RD, Jaanimägi 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.

Responsible Party:	State University of New York at Buffalo
ClinicalTrials.gov Identifier:	NCT01559454 History of Changes
Other Study ID Numbers:	FMD0600908A
First Posted:	March 21, 2012
Results First Posted:	February 20, 2017
Last Update Posted:	February 20, 2017
Last Verified:	January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	We are preparing a de-identified data set that could be shared.

Keywords provided by State University of New York at Buffalo:

chronic pain; opioid dependence; methadone; buprenorphine; substance use disorder

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Analgesics, Opioid; Buprenorphine; Methadone; Buprenorphine, Naloxone Drug Combination	Naloxone; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Narcotic Antagonists; Antitussive Agents; Respiratory System Agents