Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 47 of 186 for:    BUPRENORPHINE AND NALOXONE

Buprenorphine vs. Opioid Dose Escalation Among Patients With Chronic Pain (Bup)

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: NCT01875848
Recruitment Status : Terminated (Data safety monitoring board recommended due to low recruitment yield.)
First Posted : June 12, 2013
Results First Posted : December 21, 2016
Last Update Posted : December 21, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: buprenorphine/naloxone
Drug: opioid dose escalation
Enrollment 7
Recruitment Details Identify potentially eligible individuals that are prescribed an active opioid of 30-100mg. Patients are screened through medical records and referral from primary care providers in addition to a opt out letter and follow up phone call.
Pre-assignment Details  
Arm/Group Title Buprenorphine/Naloxone Opioid Dose Escalation
Hide Arm/Group Description

induction onto buprenorphine/naloxone from opioid treatment

buprenorphine/naloxone: partial opioid agonist

increase of up to 25% of current opioid dose

opioid dose escalation: up to 25% increase in patient's current opioid dose

Period Title: Overall Study
Started 3 [1] 4 [2]
Completed 1 [3] 4 [4]
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             2             0
[1]
3 patients were enrolled in the Buprenorphine arm of the study
[2]
4 patients were enrolled in the opioid dose escalation arm of the study
[3]
1 patient completed the Buprenorphine arm of the study. 2 patients withdrew
[4]
4 patients completed the opioid dose escalation arm of the study
Arm/Group Title Buprenorphine/Naloxone Opioid Dose Escalation Total
Hide Arm/Group Description

induction onto buprenorphine/naloxone from opioid treatment

buprenorphine/naloxone: partial opioid agonist

increase of up to 25% of current opioid dose

opioid dose escalation: up to 25% increase in patient's current opioid dose

Total of all reporting groups
Overall Number of Baseline Participants 3 4 7
Hide Baseline Analysis Population Description
Participants were recruited and enrolled at VACT West Haven, CT. Participants are aged 18 and older and have 3 months or more of continuous opioid therapy for chronic pain. Participants are actively prescribed 30-100mg of morphine equivalent opioid dose based on pharmacy records. Primary Care Providers will assent for patient participation.
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 7 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
1
  25.0%
1
  14.3%
>=65 years
3
 100.0%
3
  75.0%
6
  85.7%
[1]
Measure Description: We will measure a range of pre-treatment variables at baseline to ensure that participants meet eligibility criteria. Using validated instruments during treatment and at the end of treatment, we will examine the differential impact of BUP/NX versus opioid dose escalation including outcome assessments related to pain severity, pain interference and patient global assessment of change during treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 4 participants 7 participants
67.0  (4.6) 69.8  (9.5) 68.6  (7.4)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 7 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
3
 100.0%
4
 100.0%
7
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 4 participants 7 participants
3 4 7
1.Primary Outcome
Title Change in Numeric Rating Scale of Pain Severity
Hide Description Validated 11 pt scale 0-10, to evaluate a patient's current severity of pain. A rating of 0 indicates no pain while 10 indicates the worst pain imaginable. A score of 4 or above is considered a clinically significant pain level according to VHA treatment guidelines.
Time Frame Baseline and 12 wks
Hide Outcome Measure Data
Hide Analysis Population Description
This group of subjects consisted of five males. One Buprenorphine subject aged-72 and four Opioid Dose Escalation subjects aged- 66,77,78,and 58.
Arm/Group Title Buprenorphine/Naloxone Opioid Dose Escalation
Hide Arm/Group Description:

induction onto buprenorphine/naloxone from opioid treatment

buprenorphine/naloxone: partial opioid agonist

increase of up to 25% of current opioid dose

opioid dose escalation: up to 25% increase in patient's current opioid dose

Overall Number of Participants Analyzed 1 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2 [1]   (NA) 0.5  (1)
[1]
Not able to calculate a standard deviation. 1 subject completed this arm of the study.
2.Secondary Outcome
Title Patient Global Impression of Change (PGIC)
Hide Description The "Patient Global Impression of Change Scale" (PGIC) is one question capturing the individual's overall perception of efficacy of treatment in a clinical trial. It uses verbal outcome categories on a 7-point scale with "very much worse" and "very much better" as anchors and "no change" in the middle. The verbal categories were coded on a scale with -3 "very much worse",+3 "very much better", and 0 "same". To calculate the mean and standard deviation of each group (Bup/Opioid Increase) we took the sum of each participants final PGIC score and divided by the total number of participants.
Time Frame 12 wks
Hide Outcome Measure Data
Hide Analysis Population Description
This group of subjects consisted of five males. One Buprenorphine subject aged-72 and four Opioid Dose Escalation subjects aged- 66,77,78,and 58.
Arm/Group Title Buprenorphine/Naloxone Opioid Dose Escalation
Hide Arm/Group Description:

induction onto buprenorphine/naloxone from opioid treatment

buprenorphine/naloxone: partial opioid agonist

increase of up to 25% of current opioid dose

opioid dose escalation: up to 25% increase in patient's current opioid dose

Overall Number of Participants Analyzed 1 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
1 [1]   (NA) 1  (1.15)
[1]
Not able to calculate a standard deviation. 1 subject completed this arm of the study.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Buprenorphine/Naloxone Opioid Dose Escalation
Hide Arm/Group Description

induction onto buprenorphine/naloxone from opioid treatment

buprenorphine/naloxone: partial opioid agonist

increase of up to 25% of current opioid dose

opioid dose escalation: up to 25% increase in patient's current opioid dose

All-Cause Mortality
Buprenorphine/Naloxone Opioid Dose Escalation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Buprenorphine/Naloxone Opioid Dose Escalation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Buprenorphine/Naloxone Opioid Dose Escalation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/4 (0.00%) 
Aim 1 of the study was achieved: we found that despite moderate to high levels of pain interference, only a small proportion of eligible patients entered the trial. For this reason, the data & safety monitoring board recommended early termination.
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: William, Becker M.D
Organization: VACT West Haven HealthCare System
Phone: 203-932-5711 ext 2247
EMail: william.becker4@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01875848     History of Changes
Other Study ID Numbers: PPO 13-184
First Submitted: May 28, 2013
First Posted: June 12, 2013
Results First Submitted: June 9, 2016
Results First Posted: December 21, 2016
Last Update Posted: December 21, 2016