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
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Drug: Methadone Drug: Buprenorphine/naloxone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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 Name: Dolophine
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 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
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|