Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients
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ClinicalTrials.gov Identifier: NCT01559454 |
Recruitment Status :
Completed
First Posted : March 21, 2012
Results First Posted : February 20, 2017
Last Update Posted : November 3, 2020
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Condition or disease | Intervention/treatment | Phase |
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Low Back Pain | Drug: Methadone Drug: Buprenorphine/naloxone | Phase 4 |

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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Methadone
10-60 mg/day divided by 2-4 times a day
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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
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Drug: Buprenorphine/naloxone
4-16 mg/day divided by 2-4 times a day for 6 months
Other Name: Suboxone |
- 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.
- Illicit Drug Use [ Time Frame: 6 months ]Illicit opioid use will be measured by self-report and confirmed with urine toxicology.
- 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
- 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."
- 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."
- Treatment Retention [ Time Frame: 6 months ]Number of participants that completed the study protocol

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559454
United States, New York | |
UB/MD Family Medicine, Inc. | |
Amherst, New York, United States, 14228 |
Study Director: | Rachel A Rizzo, MPH | University at Buffalo |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Richard Blondell, Principal Investigator, State University of New York at Buffalo |
ClinicalTrials.gov Identifier: | NCT01559454 |
Other Study ID Numbers: |
FMD0600908A |
First Posted: | March 21, 2012 Key Record Dates |
Results First Posted: | February 20, 2017 |
Last Update Posted: | November 3, 2020 |
Last Verified: | October 2020 |
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. |
chronic pain opioid dependence methadone buprenorphine substance use disorder |
Back Pain Low Back Pain Pain Neurologic Manifestations Buprenorphine Methadone Buprenorphine, Naloxone Drug Combination Naloxone Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists Antitussive Agents Respiratory System Agents |