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Trial record 87 of 186 for:    BUPRENORPHINE AND NALOXONE

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 : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
State University of New York at Buffalo

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Low Back Pain
Interventions Drug: Methadone
Drug: Buprenorphine/naloxone
Enrollment 19
Recruitment Details Recruitment occurred between January 2012 and December 2013 at an ambulatory care medical clinic. Follow-up data collection lasted until May 2014
Pre-assignment Details 25 participants were assessed, but 6 were excluded for: unwilling to be randomized, DAST score below minimum, not opioid dependent, prior maintenance therapy, no prior surgery, and initial toxicology positive for cocaine (one patient per category)
Arm/Group Title Methadone Buprenorphine/Naloxone
Hide Arm/Group Description

10-60 mg/day divided by 2-4 times a day

Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months

4-16 mg/day divided by 2-4 times a day

Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months

Period Title: Overall Study
Started 9 10
Completed 6 4
Not Completed 3 6
Reason Not Completed
Lost to Follow-up             3             2
Withdrawal by Subject             0             1
Physician Decision             0             1
Protocol Violation             0             1
Lack of Efficacy             0             1
Arm/Group Title Methadone Buprenorphine/Naloxone Total
Hide Arm/Group Description

10-60 mg/day divided by 2-4 times a day

Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months

4-16 mg/day divided by 2-4 times a day

Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months

Total of all reporting groups
Overall Number of Baseline Participants 9 10 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
10
 100.0%
19
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 10 participants 19 participants
44.44  (11.85) 38.20  (9.16) 41.16  (10.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
Female
7
  77.8%
6
  60.0%
13
  68.4%
Male
2
  22.2%
4
  40.0%
6
  31.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
9
 100.0%
10
 100.0%
19
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  11.1%
2
  20.0%
3
  15.8%
White
7
  77.8%
8
  80.0%
15
  78.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  11.1%
0
   0.0%
1
   5.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 10 participants 19 participants
9 10 19
disabled  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
disabled 7 6 13
not disabled 2 4 6
never married  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
never married 3 6 9
current of prior marriage 6 4 10
past lower back surgery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
past lower back surgery 3 6 9
other spinal surgery 6 4 10
current treatment for back pain  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
current treatment 6 6 12
past treatment 3 4 7
drug and alcohol treatment history  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
past addiction treatment 2 3 5
no past addiction treatment 7 7 14
criminal history  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
any prior arrest 4 1 5
no prior arrests 5 9 14
education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
some college 3 6 9
high school or less 6 4 10
1.Primary Outcome
Title Analgesia
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
19 participants were enrolled in the study, and 10 were available for the 6-month follow-up.
Arm/Group Title Methadone Buprenorphine/Naloxone
Hide Arm/Group Description:

10-60 mg/day divided by 2-4 times a day

Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months

4-16 mg/day divided by 2-4 times a day

Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months

Overall Number of Participants Analyzed 6 4
Mean (Standard Deviation)
Unit of Measure: units on a VAS scale
36.3  (22.4) 71.8  (20.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone, Buprenorphine/Naloxone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.097
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 35.4167
Confidence Interval (2-Sided) 95%
-8.7519 to 79.5852
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Illicit Drug Use
Hide Description Illicit opioid use will be measured by self-report and confirmed with urine toxicology.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
19 participants were enrolled in the study, and 10 were available at the 6-month follow-up
Arm/Group Title Methadone Buprenorphine/Naloxone
Hide Arm/Group Description:

10-60 mg/day divided by 2-4 times a day

Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months

4-16 mg/day divided by 2-4 times a day

Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months

Overall Number of Participants Analyzed 6 4
Measure Type: Number
Unit of Measure: participants
illicit drug use at 6 months 0 0
no illicit drug use at 6 months 6 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone, Buprenorphine/Naloxone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
0.0713 to 1.8248
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Cravings
Hide Description Cravings will be assessed using the Visual Analogue Scale (VAS) with 0 being no cravings and 100 being worse possible cravings
Time Frame at 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methadone Buprenorphine/Naloxone
Hide Arm/Group Description:

10-60 mg/day divided by 2-4 times a day

Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months

4-16 mg/day divided by 2-4 times a day

Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months

Overall Number of Participants Analyzed 6 4
Mean (Standard Deviation)
Unit of Measure: units on a VAS scale
11.7  (18.1) 27.2  (31.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone, Buprenorphine/Naloxone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.348
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 15.55075
Confidence Interval (2-Sided) 95%
-20.37051 to 51.34968
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Functioning
Hide Description Functioning will be assessed using the Visual Analogue Scale (VAS) with 0 being "no limits" and 100 being "bedridden."
Time Frame at 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methadone Buprenorphine/Naloxone
Hide Arm/Group Description:

10-60 mg/day divided by 2-4 times a day

Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months

4-16 mg/day divided by 2-4 times a day

Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months

Overall Number of Participants Analyzed 6 4
Mean (Standard Deviation)
Unit of Measure: units on a VAS scale
31.7  (25.1) 71.3  (16.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone, Buprenorphine/Naloxone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.088
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 39.5833
Confidence Interval (2-Sided) 95%
-7.9653 to 87.1320
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Depression
Hide Description Depression will be assessed using the Beck Depression Inventory, a 63 point scale with 0 being "none" and 63 being "severe."
Time Frame at 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methadone Buprenorphine/Naloxone
Hide Arm/Group Description:

10-60 mg/day divided by 2-4 times a day

Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months

4-16 mg/day divided by 2-4 times a day

Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months

Overall Number of Participants Analyzed 6 4
Mean (Standard Deviation)
Unit of Measure: units on a BDI scale
17.0  (18.2) 15.3  (14.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone, Buprenorphine/Naloxone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.895
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.1499
Confidence Interval (2-Sided) 95%
-30.3965 to 27.0632
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Treatment Retention
Hide Description Number of participants that completed the study protocol
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methadone Buprenorphine/Naloxone
Hide Arm/Group Description:

10-60 mg/day divided by 2-4 times a day

Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months

4-16 mg/day divided by 2-4 times a day

Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months

Overall Number of Participants Analyzed 9 10
Measure Type: Number
Unit of Measure: participants
completed 6 4
did not complete 3 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone, Buprenorphine/Naloxone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6999
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
0.127 to 2.8352
Estimation Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description Drug overdose
 
Arm/Group Title Methadone Buprenorphine/Naloxone
Hide Arm/Group Description Methadone 10-60 mg/day divided 2-4 times a day for 6 months Buprenorphine 4-16 mg/day divided 2-4 times a day for 6 months
All-Cause Mortality
Methadone Buprenorphine/Naloxone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Methadone Buprenorphine/Naloxone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/9 (11.11%)      0/10 (0.00%)    
Social circumstances     
drug overdose *  1/9 (11.11%)  1 0/10 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Methadone Buprenorphine/Naloxone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/10 (0.00%)    
Early termination due to human subject concerns
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ricahrd Blondell
Organization: University at Buffalo
Phone: 716-816-7237
EMail: blondell@buffalo.edu
Layout table for additonal information
Responsible Party: State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT01559454     History of Changes
Other Study ID Numbers: FMD0600908A
First Submitted: March 19, 2012
First Posted: March 21, 2012
Results First Submitted: January 22, 2016
Results First Posted: February 20, 2017
Last Update Posted: February 20, 2017