Trial Outcomes & Findings for The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder (NCT NCT04981678)
NCT ID: NCT04981678
Last Updated: 2024-12-13
Results Overview
Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain)
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
12 participants
Primary outcome timeframe
24 hours after surgery
Results posted on
2024-12-13
Participant Flow
Participant milestones
| Measure |
Buprenorphine Dose Reduction
Patients instructed to reduce buprenorphine to 8mg prior to surgery
Buprenorphine: Patients randomized to this group will reduce their buprenorphine dose prior to surgery.
|
Buprenorphine Full Dose Continuation
Patients instructed to continue taking the full prescribed dose of buprenorphine.
Buprenorphine: Patients randomized to this group will continue their buprenorphine at the full prescribed dose.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Buprenorphine Dose Reduction
Patients instructed to reduce buprenorphine to 8mg prior to surgery
Buprenorphine: Patients randomized to this group will reduce their buprenorphine dose prior to surgery.
|
Buprenorphine Full Dose Continuation
Patients instructed to continue taking the full prescribed dose of buprenorphine.
Buprenorphine: Patients randomized to this group will continue their buprenorphine at the full prescribed dose.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder
Baseline characteristics by cohort
| Measure |
Buprenorphine Dose Reduction
n=6 Participants
Patients instructed to reduce buprenorphine to 8mg prior to surgery
Buprenorphine: Patients randomized to this group will reduce their buprenorphine dose prior to surgery.
|
Buprenorphine Full Dose Continuation
n=6 Participants
Patients instructed to continue taking the full prescribed dose of buprenorphine.
Buprenorphine: Patients randomized to this group will continue their buprenorphine at the full prescribed dose.
|
Total
n=12 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
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
40.5 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
40.6 years
STANDARD_DEVIATION 50.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Current buprenorphine dose
|
15 mg
n=5 Participants
|
16 mg
n=7 Participants
|
16 mg
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours after surgeryHighest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain)
Outcome measures
| Measure |
Buprenorphine Dose Reduction
n=6 Participants
Patients instructed to reduce buprenorphine to 8mg prior to surgery
Buprenorphine: Patients randomized to this group will reduce their buprenorphine dose prior to surgery.
|
Buprenorphine Full Dose Continuation
n=6 Participants
Patients instructed to continue taking the full prescribed dose of buprenorphine.
Buprenorphine: Patients randomized to this group will continue their buprenorphine at the full prescribed dose.
|
|---|---|---|
|
Post-operative Pain Scores: 24 Hours After Surgery
Average
|
7.2 score on a scale (NRS pain scale)
Standard Deviation 1.5
|
5.8 score on a scale (NRS pain scale)
Standard Deviation 2.4
|
|
Post-operative Pain Scores: 24 Hours After Surgery
Lowest
|
6.0 score on a scale (NRS pain scale)
Standard Deviation 2.4
|
4.5 score on a scale (NRS pain scale)
Standard Deviation 2.7
|
|
Post-operative Pain Scores: 24 Hours After Surgery
Highest
|
8.3 score on a scale (NRS pain scale)
Standard Deviation 1.4
|
7.4 score on a scale (NRS pain scale)
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: 48 hours after surgeryHighest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain)
Outcome measures
| Measure |
Buprenorphine Dose Reduction
n=6 Participants
Patients instructed to reduce buprenorphine to 8mg prior to surgery
Buprenorphine: Patients randomized to this group will reduce their buprenorphine dose prior to surgery.
|
Buprenorphine Full Dose Continuation
n=6 Participants
Patients instructed to continue taking the full prescribed dose of buprenorphine.
Buprenorphine: Patients randomized to this group will continue their buprenorphine at the full prescribed dose.
|
|---|---|---|
|
Post-operative Pain Scores: 48 Hours After Surgery
Average
|
6.8 score on a scale (NRS)
Standard Deviation 2.5
|
5.4 score on a scale (NRS)
Standard Deviation 1.6
|
|
Post-operative Pain Scores: 48 Hours After Surgery
Lowest
|
6.2 score on a scale (NRS)
Standard Deviation 2.5
|
2.8 score on a scale (NRS)
Standard Deviation 0.8
|
|
Post-operative Pain Scores: 48 Hours After Surgery
Highest
|
7.8 score on a scale (NRS)
Standard Deviation 2.3
|
7.7 score on a scale (NRS)
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: 72 hours after surgeryHighest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain)
Outcome measures
| Measure |
Buprenorphine Dose Reduction
n=6 Participants
Patients instructed to reduce buprenorphine to 8mg prior to surgery
Buprenorphine: Patients randomized to this group will reduce their buprenorphine dose prior to surgery.
|
Buprenorphine Full Dose Continuation
n=6 Participants
Patients instructed to continue taking the full prescribed dose of buprenorphine.
Buprenorphine: Patients randomized to this group will continue their buprenorphine at the full prescribed dose.
|
|---|---|---|
|
Post-operative Pain Scores: 72 Hours After Surgery
Average
|
6.6 score on a scale (NRS)
Standard Deviation 1.6
|
5.1 score on a scale (NRS)
Standard Deviation 2.3
|
|
Post-operative Pain Scores: 72 Hours After Surgery
Lowest
|
5.2 score on a scale (NRS)
Standard Deviation 1.6
|
4.1 score on a scale (NRS)
Standard Deviation 2.5
|
|
Post-operative Pain Scores: 72 Hours After Surgery
Highest
|
7.4 score on a scale (NRS)
Standard Deviation 1.9
|
6.1 score on a scale (NRS)
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 3 days post-opAll opioids consumed through 72 hours after surgery combined into mean morphine equivalents
Outcome measures
| Measure |
Buprenorphine Dose Reduction
n=6 Participants
Patients instructed to reduce buprenorphine to 8mg prior to surgery
Buprenorphine: Patients randomized to this group will reduce their buprenorphine dose prior to surgery.
|
Buprenorphine Full Dose Continuation
n=6 Participants
Patients instructed to continue taking the full prescribed dose of buprenorphine.
Buprenorphine: Patients randomized to this group will continue their buprenorphine at the full prescribed dose.
|
|---|---|---|
|
Opioid Consumption
|
37.25 morphine milligram equivalents (MME)
Interval 0.0 to 140.0
|
41.43 morphine milligram equivalents (MME)
Interval 0.0 to 320.0
|
SECONDARY outcome
Timeframe: 30 days following surgeryPrescriptions filled for the patient in the Prescription Awareness Tool
Outcome measures
| Measure |
Buprenorphine Dose Reduction
n=6 Participants
Patients instructed to reduce buprenorphine to 8mg prior to surgery
Buprenorphine: Patients randomized to this group will reduce their buprenorphine dose prior to surgery.
|
Buprenorphine Full Dose Continuation
n=5 Participants
Patients instructed to continue taking the full prescribed dose of buprenorphine.
Buprenorphine: Patients randomized to this group will continue their buprenorphine at the full prescribed dose.
|
|---|---|---|
|
Opioid Dispensing
|
262 morphine milligram equivalents
Interval 0.0 to 915.0
|
308 morphine milligram equivalents
Interval 0.0 to 519.0
|
SECONDARY outcome
Timeframe: 1-3 hours prior to surgeryWithdrawal symptoms as measured by the Clinical Opioid Withdrawal Scale (COWS, scores can range from 0-48 \[5-12 mild; 13-24, moderate; 25-36, moderately severe; \>36, severe withdrawal)
Outcome measures
| Measure |
Buprenorphine Dose Reduction
n=6 Participants
Patients instructed to reduce buprenorphine to 8mg prior to surgery
Buprenorphine: Patients randomized to this group will reduce their buprenorphine dose prior to surgery.
|
Buprenorphine Full Dose Continuation
n=6 Participants
Patients instructed to continue taking the full prescribed dose of buprenorphine.
Buprenorphine: Patients randomized to this group will continue their buprenorphine at the full prescribed dose.
|
|---|---|---|
|
Opioid Withdrawal
less than 5 on the COWS scale
|
5 Participants
|
5 Participants
|
|
Opioid Withdrawal
5-12 on the COWS scale, mild withdrawal
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1-3 hours prior to surgeryMeasured by the Opioid Craving Scale (OCS); scale ranges from 0-30 with higher scores indicating higher levels of cravings
Outcome measures
| Measure |
Buprenorphine Dose Reduction
n=6 Participants
Patients instructed to reduce buprenorphine to 8mg prior to surgery
Buprenorphine: Patients randomized to this group will reduce their buprenorphine dose prior to surgery.
|
Buprenorphine Full Dose Continuation
n=6 Participants
Patients instructed to continue taking the full prescribed dose of buprenorphine.
Buprenorphine: Patients randomized to this group will continue their buprenorphine at the full prescribed dose.
|
|---|---|---|
|
Opioid Cravings
|
2.17 score on a scale
Interval 0.0 to 9.0
|
2 score on a scale
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: 30 days following surgeryMeasured by the Opioid Craving Scale (OCS); scale ranges from 0-30 with higher scores indicating higher levels of cravings
Outcome measures
| Measure |
Buprenorphine Dose Reduction
n=6 Participants
Patients instructed to reduce buprenorphine to 8mg prior to surgery
Buprenorphine: Patients randomized to this group will reduce their buprenorphine dose prior to surgery.
|
Buprenorphine Full Dose Continuation
n=5 Participants
Patients instructed to continue taking the full prescribed dose of buprenorphine.
Buprenorphine: Patients randomized to this group will continue their buprenorphine at the full prescribed dose.
|
|---|---|---|
|
Opioid Cravings
|
0.67 score on a scale
Interval 0.0 to 4.0
|
3 score on a scale
Interval 0.0 to 13.0
|
SECONDARY outcome
Timeframe: 1-3 hours prior to surgeryMeasured by the Current Opioid Misuse Measure ((COMM); scores can range from 0-68, scores of 9 or lower indicates a low risk of opioid misuse or abuse, scores higher than 9 indicate a high risk)
Outcome measures
| Measure |
Buprenorphine Dose Reduction
n=6 Participants
Patients instructed to reduce buprenorphine to 8mg prior to surgery
Buprenorphine: Patients randomized to this group will reduce their buprenorphine dose prior to surgery.
|
Buprenorphine Full Dose Continuation
n=6 Participants
Patients instructed to continue taking the full prescribed dose of buprenorphine.
Buprenorphine: Patients randomized to this group will continue their buprenorphine at the full prescribed dose.
|
|---|---|---|
|
Opioid Misuse
|
2.83 score on a scale (COMM)
Interval 0.0 to 10.0
|
7 score on a scale (COMM)
Interval 0.0 to 15.0
|
SECONDARY outcome
Timeframe: 30 days following surgeryMeasured by the Current Opioid Misuse Measure ((COMM); scores can range from 0-68, scores of 9 or lower indicates a low risk of opioid misuse or abuse, scores higher than 9 indicate a high risk)
Outcome measures
| Measure |
Buprenorphine Dose Reduction
n=6 Participants
Patients instructed to reduce buprenorphine to 8mg prior to surgery
Buprenorphine: Patients randomized to this group will reduce their buprenorphine dose prior to surgery.
|
Buprenorphine Full Dose Continuation
n=5 Participants
Patients instructed to continue taking the full prescribed dose of buprenorphine.
Buprenorphine: Patients randomized to this group will continue their buprenorphine at the full prescribed dose.
|
|---|---|---|
|
Opioid Misuse
|
3.33 score on a scale (COMM)
Interval 0.0 to 10.0
|
8 score on a scale (COMM)
Interval 1.0 to 18.0
|
SECONDARY outcome
Timeframe: 30 days following surgeryPatient reported use of non-prescribed opioids
Outcome measures
| Measure |
Buprenorphine Dose Reduction
n=6 Participants
Patients instructed to reduce buprenorphine to 8mg prior to surgery
Buprenorphine: Patients randomized to this group will reduce their buprenorphine dose prior to surgery.
|
Buprenorphine Full Dose Continuation
n=5 Participants
Patients instructed to continue taking the full prescribed dose of buprenorphine.
Buprenorphine: Patients randomized to this group will continue their buprenorphine at the full prescribed dose.
|
|---|---|---|
|
Opioid Relapse
|
0 number of patients reporting relapse
|
0 number of patients reporting relapse
|
Adverse Events
Buprenorphine Full Dose Continuation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Buprenorphine Dose Reduction
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
Lead Research Coordinator
MaineHealth, Department of Anethesiology
Phone: 207-662-2862
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place