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Trial record 74 of 186 for:    BUPRENORPHINE AND NALOXONE

Buprenorphine Treatment: A Safe Alternative for Opioid Dependent Pain Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01841931
Recruitment Status : Terminated (Principal Investigator is no longer at this site)
First Posted : April 29, 2013
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Maimonides Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Opioid Use Disorder
Intervention Drug: Buprenorphine/Naloxone
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patient
Hide Arm/Group Description Enrolled patients
Period Title: Overall Study
Started 4
Completed 0 [1]
Not Completed 4
[1]
As the PI left the institution the study was terminated
Arm/Group Title Patient
Hide Arm/Group Description Enrolled patients
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
Chronic pain patients with opioid dependence
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
2
  66.7%
Male
1
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
Pain severity   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 3 participants
7
(4 to 10)
[1]
Measure Description: Pain Severity measured with a numeric scale (0 to 10) - Brief Pain Inventory (BPI)
1.Primary Outcome
Title Opiate Withdrawal
Hide Description Goal that patients will have NO withdrawal symptoms by the completion of their 3-day buprenorphine induction, and will remain withdrawal-free for the entire study duration.Assessed using Clinical Opiate Withdrawal Scale (COWS).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patient
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Enrolled patients
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Pain Severity
Hide Description

Pain severity will be measured using a numeric scale from 0 (no pain) to 10 (pain as bad as you can imagine), adopted from the Brief Pain Inventory (BPI).

No results to report.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled patients
Arm/Group Title Patient
Hide Arm/Group Description:
Enrolled patients
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Psychiatric Distress
Hide Description The investigators will utilize the SCL-6 (Symptoms Checklist 6, a validated abbreviated version of the SCL-90) to assess patients' psychological well being.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled patients
Arm/Group Title Patient
Hide Arm/Group Description:
Enrolled patients
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Quality of Life
Hide Description Investigators will use the QOL (EuroQol EQ5D) questionnaire, which assess patients' self-assessment of health and health-related quality of life.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled patients
Arm/Group Title Patient
Hide Arm/Group Description:
Enrolled patients
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Positive Affect
Hide Description The investigators will assess patients' moods/affects using the PANAS (Positive Affect Negative Affect Scale).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled patients
Arm/Group Title Patient
Hide Arm/Group Description:
Enrolled patients
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patient
Hide Arm/Group Description Enrolled patients
All-Cause Mortality
Patient
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Patient
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patient
Affected / at Risk (%)
Total   0/3 (0.00%) 

Study was prematurely terminated as the PI left the institution.

Early termination lead to small numbers of subject enrollment and only baseline data. No data collection at 6 months or thereafter.

No adverse events.

No results to report.

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: Director of Research, Department of Psychiatry
Organization: Maimonides Medical Center
Phone: 718-283-7162
EMail: tjacob@maimonidesmed.org
Layout table for additonal information
Responsible Party: Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT01841931     History of Changes
Other Study ID Numbers: 11/09/VA05
First Submitted: January 25, 2013
First Posted: April 29, 2013
Results First Submitted: March 23, 2018
Results First Posted: April 23, 2018
Last Update Posted: April 23, 2018