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Trial record 90 of 186 for:    BUPRENORPHINE AND NALOXONE

Buprenorphine as a Treatment in Opiate Dependent Pain Patients

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ClinicalTrials.gov Identifier: NCT00552578
Recruitment Status : Terminated ("Tapering doses" protocol arm was not effective for treatment retention outcome.)
First Posted : November 2, 2007
Results First Posted : July 7, 2009
Last Update Posted : February 17, 2011
Sponsor:
Information provided by:
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
Conditions Opiate Addiction
Refractory Pain
Intervention Drug: buprenorphine/naloxone
Enrollment 12
Recruitment Details 12 participants recruited Dec 2007 to Apr 2008
Pre-assignment Details  
Arm/Group Title Tapering Doses of Buprenorphine Steady Dose of Buprenorphine
Hide Arm/Group Description Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification. Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
Period Title: Overall Study
Started 6 6
Completed 5 5
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             1
Arm/Group Title Tapering Doses of Buprenorphine Steady Dose of Buprenorphine Total
Hide Arm/Group Description Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification. Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance. Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
6
 100.0%
12
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
44  (6) 46  (15) 45  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
4
  66.7%
2
  33.3%
6
  50.0%
Male
2
  33.3%
4
  66.7%
6
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 12 participants
6 6 12
1.Primary Outcome
Title Relapse to Substance Abuse
Hide Description Relapse to substance abuse (yes/no) was determined by participant self-report or by a positive urine toxicology.
Time Frame Six months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tapering Doses of Buprenorphine Steady Dose of Buprenorphine
Hide Arm/Group Description:
Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
Overall Number of Participants Analyzed 5 5
Measure Type: Number
Unit of Measure: participants
2 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapering Doses of Buprenorphine, Steady Dose of Buprenorphine
Comments Intent to treat
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.523
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.17
Confidence Interval 95%
0.0098 to 2.8215
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline.
Hide Description Qualitative measure (better/no change/worse) of participant's perception of overall quality of life related to assigned study protocol arm.
Time Frame Baseline and six months
Hide Outcome Measure Data
Hide Analysis Population Description
Reported value (number) was the number who reported a "better" overall quality-of-life to the question: "How would you describe your overall level of function now as compared to the time right before you started the study?" Responses were recorded as: "better," "no change," or "worse."
Arm/Group Title Tapering Doses of Buprenorphine Steady Dose of Buprenorphine
Hide Arm/Group Description:
Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
Overall Number of Participants Analyzed 5 5
Measure Type: Number
Unit of Measure: Participants
4 4
3.Secondary Outcome
Title Treatment Retention.
Hide Description "Treatment retention" was defined as the completion of the buprenorphine dosing protocol (i.e., tapering doses vs. steady doses).
Time Frame Six months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent-to-treat.
Arm/Group Title Tapering Doses of Buprenorphine Steady Dose of Buprenorphine
Hide Arm/Group Description:
Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: Participants
0 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapering Doses of Buprenorphine, Steady Dose of Buprenorphine
Comments Fisher exact test was used and tested the hypothesis that neither group would be more likely to complete the study protocol.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments No adjustment
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tapering Doses of Buprenorphine Steady Dose of Buprenorphine
Hide Arm/Group Description Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification. Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
All-Cause Mortality
Tapering Doses of Buprenorphine Steady Dose of Buprenorphine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tapering Doses of Buprenorphine Steady Dose of Buprenorphine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tapering Doses of Buprenorphine Steady Dose of Buprenorphine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: R Blondell
Organization: SUNY Buffalo
Phone: 716-898-4971
EMail: blondell@buffalo.edu
Layout table for additonal information
Responsible Party: Richard D. Blondell, SUNYBuffalo, Dept Family Medicine
ClinicalTrials.gov Identifier: NCT00552578     History of Changes
Other Study ID Numbers: FMD0400907A
First Submitted: November 1, 2007
First Posted: November 2, 2007
Results First Submitted: January 21, 2009
Results First Posted: July 7, 2009
Last Update Posted: February 17, 2011