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Trial record 52 of 186 for:    BUPRENORPHINE AND NALOXONE

Prescription Opioid Abuse Among Pain Patients: Predictors of Relapse (PAIN)

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ClinicalTrials.gov Identifier: NCT01967641
Recruitment Status : Completed
First Posted : October 23, 2013
Results First Posted : June 15, 2018
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Frances R Levin, New York State Psychiatric Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Opioid Dependence
Intervention Drug: buprenorphine/naloxone combination
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Buprenorphine/Naloxone Combination
Hide Arm/Group Description Fifty-one (51) participants met inclusion/exclusion criteria and were randomized to a starting dose of buprenorphine/naloxone in the study (three doses were tested for 2 weeks at each dose).
Period Title: Randomized
Started 51
Completed 43 [1]
Not Completed 8
[1]
Completed week 12
Period Title: Admission to Inpatient Phase
Started 43
Completed 31 [1]
Not Completed 12
[1]
Completed 7 week inpatient phase
Period Title: 12-week Outpatient Phase
Started 31
Completed 18 [1]
Not Completed 13
[1]
Completed week 12 of outpatient phase
Arm/Group Title Buprenorphine/Naloxone Combination
Hide Arm/Group Description Fifty-one (51) participants met inclusion/exclusion criteria and were randomized to a starting dose of buprenorphine/naloxone in the study (three doses were tested for 2 weeks at each dose).
Overall Number of Baseline Participants 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants
47.5  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
Female
23
  45.1%
Male
28
  54.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants
Caucaisan 23
African American 15
Hispanic 11
unknown 2
1.Primary Outcome
Title Number of Participants Retained in Study
Hide Description Retention was number of participants retained at study end (Week 19).
Time Frame week 19
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buprenorphine/Naloxone Combination
Hide Arm/Group Description:
Fifty-one (51) participants met inclusion/exclusion criteria and were randomized to a starting dose of buprenorphine/naloxone in the study (three doses were tested for 2 weeks at each dose).
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: participants
18
2.Secondary Outcome
Title Number of Participants Abstinent From Opioids
Hide Description Relapse was number of participants with opioid-negative urine toxicology in last week of study participation.
Time Frame at week 19 or length of study participation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buprenorphine/Naloxone Combination
Hide Arm/Group Description:
Thirty-one (31) participants who initiated outpatient phase
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: participants
17
3.Secondary Outcome
Title Pain Measurement
Hide Description The primary pain measure was the Pain Assessment and Documentation Tool (PADT). Total score ranging from 0-11 reported. Higher score considered indicative of more pain. Lower score is indicative of less pain.
Time Frame assessed twice weekly during course of 19 weeks or length of participation, only screening and last assessment reported.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buprenorphine/Naloxone Combination
Hide Arm/Group Description:
Thirty-one (31) participants who initiated outpatient phase
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
screening 6.1  (1.9)
end of study 4.3  (0.65)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Buprenorphine/Naloxone Combination
Hide Arm/Group Description Fifty-one (51) participants met inclusion/exclusion criteria and were randomized to a starting dose of buprenorphine/naloxone in the study (three doses were tested for 2 weeks at each dose).
All-Cause Mortality
Buprenorphine/Naloxone Combination
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Buprenorphine/Naloxone Combination
Affected / at Risk (%)
Total   7/51 (13.73%) 
Cardiac disorders   
chest pain   1/51 (1.96%) 
General disorders   
Hospitalization for rehydration/nutrition   1/51 (1.96%) 
Somnolence, BP drop; intubated in ER;   1/51 (1.96%) 
leg pain/swelling   1/51 (1.96%) 
Psychiatric disorders   
ER presentation for altered mental status after ingesting sleeping pills  [1]  1/51 (1.96%) 
Renal and urinary disorders   
Urinary tract infection   1/51 (1.96%) 
Skin and subcutaneous tissue disorders   
cellulitis   1/51 (1.96%) 
Indicates events were collected by systematic assessment
[1]
ER presentation for altered mental status after ingesting sleeping pills without self-injurious intent
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Buprenorphine/Naloxone Combination
Affected / at Risk (%)
Total   0/51 (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: Dr. Maria A. Sullivan, M.D., Ph.D
Organization: New York State Psychiatric Institute
Phone: 646-774-6152
EMail: mas23@columbia.edu
Layout table for additonal information
Responsible Party: Frances R Levin, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01967641     History of Changes
Other Study ID Numbers: #6269R
DA020448-05 ( Other Grant/Funding Number: NIH )
First Submitted: October 18, 2013
First Posted: October 23, 2013
Results First Submitted: August 7, 2017
Results First Posted: June 15, 2018
Last Update Posted: April 24, 2019