Trial Outcomes & Findings for Buprenorphine vs. Opioid Dose Escalation Among Patients With Chronic Pain (NCT NCT01875848)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

7 participants

Primary outcome timeframe

Baseline and 12 wks

Results posted on

2016-12-21

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Buprenorphine/Naloxone induction onto buprenorphine/naloxone from opioid treatment buprenorphine/naloxone: partial opioid agonist	Opioid Dose Escalation increase of up to 25% of current opioid dose opioid dose escalation: up to 25% increase in patient's current opioid dose
Overall Study STARTED	3	4
Overall Study COMPLETED	1	4
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Buprenorphine/Naloxone induction onto buprenorphine/naloxone from opioid treatment buprenorphine/naloxone: partial opioid agonist	Opioid Dose Escalation increase of up to 25% of current opioid dose opioid dose escalation: up to 25% increase in patient's current opioid dose
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Buprenorphine vs. Opioid Dose Escalation Among Patients With Chronic Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Buprenorphine/Naloxone n=3 Participants induction onto buprenorphine/naloxone from opioid treatment buprenorphine/naloxone: partial opioid agonist	Opioid Dose Escalation n=4 Participants increase of up to 25% of current opioid dose opioid dose escalation: up to 25% increase in patient's current opioid dose	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	67.0 years STANDARD_DEVIATION 4.6 • n=5 Participants	69.8 years STANDARD_DEVIATION 9.5 • n=7 Participants	68.6 years STANDARD_DEVIATION 7.4 • n=5 Participants
Gender Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Gender Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 wks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Buprenorphine/Naloxone n=1 Participants induction onto buprenorphine/naloxone from opioid treatment buprenorphine/naloxone: partial opioid agonist	Opioid Dose Escalation n=4 Participants increase of up to 25% of current opioid dose opioid dose escalation: up to 25% increase in patient's current opioid dose
Change in Numeric Rating Scale of Pain Severity	-2 units on a scale Standard Deviation NA Not able to calculate a standard deviation. 1 subject completed this arm of the study.	0.5 units on a scale Standard Deviation 1

SECONDARY outcome

Timeframe: 12 wks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Buprenorphine/Naloxone n=1 Participants induction onto buprenorphine/naloxone from opioid treatment buprenorphine/naloxone: partial opioid agonist	Opioid Dose Escalation n=4 Participants increase of up to 25% of current opioid dose opioid dose escalation: up to 25% increase in patient's current opioid dose
Patient Global Impression of Change (PGIC)	1 units on a scale Standard Deviation NA Not able to calculate a standard deviation. 1 subject completed this arm of the study.	1 units on a scale Standard Deviation 1.15

Adverse Events

Buprenorphine/Naloxone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Opioid Dose Escalation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William, Becker M.D

VACT West Haven HealthCare System

Phone: 203-932-5711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place