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Trial record 92 of 186 for:    BUPRENORPHINE AND NALOXONE

Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients

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ClinicalTrials.gov Identifier: NCT00879996
Recruitment Status : Completed
First Posted : April 13, 2009
Results First Posted : July 9, 2012
Last Update Posted : August 7, 2012
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Richard Blondell, 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 Opiate Addiction
Interventions Drug: Methadone
Drug: Buprenorphine/naloxone
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Methadone Buprenorphine/Naloxone
Hide Arm/Group Description Methadone 10-60 mg per day in 2-4 divided doses for 6 months Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
Period Title: Overall Study
Started 28 26
Completed 13 13
Not Completed 15 13
Reason Not Completed
Lost to Follow-up             7             6
non-compliance             6             4
Physician Decision             1             2
psychiatric problem             0             1
put on parole             1             0
Arm/Group Title Methadone Buprenorphine/Naloxone Total
Hide Arm/Group Description Methadone 10-60 mg per day in 2-4 divided doses for 6 months Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg) Total of all reporting groups
Overall Number of Baseline Participants 28 26 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 26 participants 54 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
 100.0%
25
  96.2%
53
  98.1%
>=65 years
0
   0.0%
1
   3.8%
1
   1.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 26 participants 54 participants
37.7  (8.6) 39.0  (10.9) 38.3  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 26 participants 54 participants
Female
16
  57.1%
9
  34.6%
25
  46.3%
Male
12
  42.9%
17
  65.4%
29
  53.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 26 participants 54 participants
28 26 54
1.Primary Outcome
Title Number of Participants Retained in Treatment
Hide Description This outcome assesses the number of participants who completed the treatment after 6 months.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that were randomized were analyzed regarding their retention in treatment at 6 months.
Arm/Group Title Methadone Buprenorphine/Naloxone
Hide Arm/Group Description:
Methadone 10-60 mg per day divided in 2-4 doses for 6 months
Buprenorphine 4-16 mg per day divided in 2-4 doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
Overall Number of Participants Analyzed 28 26
Measure Type: Number
Unit of Measure: participants
13 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone, Buprenorphine/Naloxone
Comments Null hypothesis: Methadone and buprenorphine treatment do not differ in treatment retention.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.9134
Confidence Interval (2-Sided) 95%
0.4156 to 2.007
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Numerical Rating Score for Pain
Hide Description Pain was measured using a 0-10 point numerical rating scale (NRS) with 0 representing no pain and 10 representing worst pain possible.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed the treatment at 6 months were analyzed.
Arm/Group Title Methadone Buprenorphine/Naloxone
Hide Arm/Group Description:
Methadone 10-60 mg per day in 2-4 divided doses for 6 months
Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: units on a 0-10 NRS scale
5.4  (1.1) 5.6  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone, Buprenorphine/Naloxone
Comments Null hypothesis: Methadone treatment is as effective as buprenorphine treatment in reducing pain.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.043
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Numerical Rating Score for Functioning
Hide Description We assessed functioning measured on a 0-10 point numerical rating scale (NRS)with 0 being the least amount of functioning and 10 the best amount of functioning.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The participants who completed the treatment were included in the statistical analysis.
Arm/Group Title Methadone Buprenorphine/Naloxone
Hide Arm/Group Description:
Methadone 10-60 mg per day in 2-4 divided doses for 6 months
Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: units on a 0-10 point NRS scale
5.0  (1.7) 5.3  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone, Buprenorphine/Naloxone
Comments null-hypothesis: methadone and buprenorphine treatment are equally effective in reducing self-reported functioning at 6 months.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.665
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.3
Parameter Dispersion
Type: Standard Deviation
Value: 0
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Self-reported Illicit Opioid Use
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methadone Buprenorphine/Naloxone
Hide Arm/Group Description:
Methadone 10-60 mg per day in 2-4 divided doses for 6 months
Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
Overall Number of Participants Analyzed 13 13
Measure Type: Number
Unit of Measure: number of participants
0 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone, Buprenorphine/Naloxone
Comments Null hypothesis: methadone or buprenorphine treatment equally reduce illicit drug use.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.039
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0
Parameter Dispersion
Type: Standard Deviation
Value: 0
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Methadone Buprenorphine/Naloxone
Hide Arm/Group Description Methadone 10-60 mg per day in 2-4 divided doses for 6 months Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
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 (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Methadone Buprenorphine/Naloxone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/26 (0.00%) 
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. Richard Blondell
Organization: SUNY Buffalo
Phone: 716-898-4971
EMail: blondell@buffalo.edu
Layout table for additonal information
Responsible Party: Richard Blondell, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT00879996     History of Changes
Other Study ID Numbers: FMD0350908A
K23AA015616 ( U.S. NIH Grant/Contract )
R03DA029768 ( U.S. NIH Grant/Contract )
First Submitted: April 10, 2009
First Posted: April 13, 2009
Results First Submitted: March 21, 2012
Results First Posted: July 9, 2012
Last Update Posted: August 7, 2012