Trial Outcomes & Findings for Extended-Release Buprenorphine vs. Sublingual Buprenorphine for the Treatment of Opioid Use Disorder (NCT NCT04352166)
NCT ID: NCT04352166
Last Updated: 2026-08-27
Results Overview
Change was calculated as the number of days of opioid use per week over time.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
up to 12 weeks
Results posted on
2026-08-27
Participant Flow
33 participants were enrolled into the treatment protocol. They are then randomized to receive either SL buprenorphine (approximately one or two days) and BXR injection or standard buprenorphine therapy (BSL induction and maintenance) under open-label conditions. Randomization will occur in a 1:1 ratio immediately prior to starting the induction process. Two participants decided not to continue in the treatment study prior to being randomized at the beginning of the induction process.
Participant milestones
| Measure |
Extended-release Buprenorphine (BXR)
Three extended-release buprenorphine (BXR) injections to be administered roughly 28 days apart. The first and second injection will be 300 mg and the third will be 100 mg.
extended-release buprenorphine (BXR): Three monthly injections will be provided during the course of the 12 week trial.
|
Sublingual Buprenorphine (BSL)
sublingual buprenorphine (BSL) up to 24 mg will be administered once daily for 12 weeks or length of study participation.
sublingual buprenorphine (BSL): On a weekly basis patients will be provided with sublingual buprenorphine to take up to 24 mg daily.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Extended-Release Buprenorphine vs. Sublingual Buprenorphine for the Treatment of Opioid Use Disorder
Baseline characteristics by cohort
| Measure |
Extended-release Buprenorphine (BXR)
n=16 Participants
Three extended-release buprenorphine (BXR) injections to be administered roughly 28 days apart. The first and second injection will be 300 mg and the third will be 100 mg.
extended-release buprenorphine (BXR): Three monthly injections will be provided during the course of the 12 week trial.
|
Sublingual Buprenorphine (BSL)
n=15 Participants
sublingual buprenorphine (BSL) up to 24 mg will be administered once daily for 12 weeks or length of study participation.
sublingual buprenorphine (BSL): On a weekly basis patients will be provided with sublingual buprenorphine to take up to 24 mg daily.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Age, Continuous
|
45.6 years
STANDARD_DEVIATION 11.2 • n=31 Participants
|
41.7 years
STANDARD_DEVIATION 15.4 • n=49 Participants
|
43.7 years
STANDARD_DEVIATION 13.3 • n=80 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
5 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=31 Participants
|
13 Participants
n=49 Participants
|
26 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
6 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=31 Participants
|
13 Participants
n=49 Participants
|
25 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
3 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=31 Participants
|
4 Participants
n=49 Participants
|
9 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=31 Participants
|
8 Participants
n=49 Participants
|
15 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
4 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: 16 participants started in the BXR arm and 15 participants started in the PBO arm. No missing data adjustment was performed. 8 participants remained at week 12 in the BXR arm and 5 participants in the PBO arm.
Change was calculated as the number of days of opioid use per week over time.
Outcome measures
| Measure |
Extended-release Buprenorphine (BXR)
n=16 Participants
Three extended-release buprenorphine (BXR) injections to be administered roughly 28 days apart. The first and second injection will be 300 mg and the third will be 100 mg.
extended-release buprenorphine (BXR): Three monthly injections will be provided during the course of the 12 week trial.
|
Sublingual Buprenorphine (BSL)
n=15 Participants
sublingual buprenorphine (BSL) up to 24 mg will be administered once daily for 12 weeks or length of study participation.
sublingual buprenorphine (BSL): On a weekly basis patients will be provided with sublingual buprenorphine to take up to 24 mg daily.
|
|---|---|---|
|
Change in Days of Opioid Use Per Week Over Time
Baseline Model-based estimates
|
5.42 Days per week
Interval 3.82 to 6.35
|
5.54 Days per week
Interval 2.85 to 6.68
|
|
Change in Days of Opioid Use Per Week Over Time
Week12 Model-based estimates
|
0.0054 Days per week
Interval 0.0001 to 0.2735
|
0 Days per week
Interval 0.0 to 7.0
|
Adverse Events
Extended-release Buprenorphine (BXR)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Sublingual Buprenorphine (BSL)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Extended-release Buprenorphine (BXR)
n=16 participants at risk
Three extended-release buprenorphine (BXR) injections to be administered roughly 28 days apart. The first and second injection will be 300 mg and the third will be 100 mg.
extended-release buprenorphine (BXR): Three monthly injections will be provided during the course of the 12 week trial.
|
Sublingual Buprenorphine (BSL)
n=15 participants at risk
sublingual buprenorphine (BSL) up to 24 mg will be administered once daily for 12 weeks or length of study participation.
sublingual buprenorphine (BSL): On a weekly basis patients will be provided with sublingual buprenorphine to take up to 24 mg daily.
|
|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
6.2%
1/16 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
General disorders
dizziness
|
12.5%
2/16 • Number of events 2 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
General disorders
drowsiness
|
0.00%
0/16 • Over 12 weeks of trial or length of participant's participation
|
6.7%
1/15 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
|
General disorders
sedation
|
6.2%
1/16 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
6.7%
1/15 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
|
Gastrointestinal disorders
GI Upset
|
12.5%
2/16 • Number of events 2 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
General disorders
headache
|
12.5%
2/16 • Number of events 2 • Over 12 weeks of trial or length of participant's participation
|
6.7%
1/15 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
|
Cardiac disorders
hypertension
|
12.5%
2/16 • Number of events 2 • Over 12 weeks of trial or length of participant's participation
|
6.7%
1/15 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
|
General disorders
insomnia
|
25.0%
4/16 • Number of events 4 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
General disorders
loss of libido
|
0.00%
0/16 • Over 12 weeks of trial or length of participant's participation
|
6.7%
1/15 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
|
Gastrointestinal disorders
nausea
|
12.5%
2/16 • Number of events 2 • Over 12 weeks of trial or length of participant's participation
|
20.0%
3/15 • Number of events 3 • Over 12 weeks of trial or length of participant's participation
|
|
Cardiac disorders
palpitations
|
0.00%
0/16 • Over 12 weeks of trial or length of participant's participation
|
6.7%
1/15 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
|
Gastrointestinal disorders
vomitting
|
6.2%
1/16 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
13.3%
2/15 • Number of events 2 • Over 12 weeks of trial or length of participant's participation
|
|
General disorders
weight decrease
|
6.2%
1/16 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
Musculoskeletal and connective tissue disorders
osteoarthritic pain
|
0.00%
0/16 • Over 12 weeks of trial or length of participant's participation
|
6.7%
1/15 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
|
General disorders
injection site pain
|
12.5%
2/16 • Number of events 2 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
General disorders
injection site skin irritation
|
12.5%
2/16 • Number of events 2 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
Skin and subcutaneous tissue disorders
skin infection/phlebitis
|
0.00%
0/16 • Over 12 weeks of trial or length of participant's participation
|
6.7%
1/15 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
|
General disorders
irritability
|
6.2%
1/16 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
Musculoskeletal and connective tissue disorders
back pain
|
6.2%
1/16 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
Skin and subcutaneous tissue disorders
itchiness
|
6.2%
1/16 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
Psychiatric disorders
mood lability
|
6.2%
1/16 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
General disorders
site injection Induration
|
12.5%
2/16 • Number of events 2 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
6.2%
1/16 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
Skin and subcutaneous tissue disorders
injection site itchiness
|
18.8%
3/16 • Number of events 3 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
Cardiac disorders
hypotension
|
6.2%
1/16 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
Musculoskeletal and connective tissue disorders
abdominal discomfort
|
6.2%
1/16 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
General disorders
pressure on scalp
|
0.00%
0/16 • Over 12 weeks of trial or length of participant's participation
|
6.7%
1/15 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
|
Musculoskeletal and connective tissue disorders
restless leg
|
6.2%
1/16 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
Skin and subcutaneous tissue disorders
injection site redness
|
6.2%
1/16 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
Musculoskeletal and connective tissue disorders
head trauma
|
6.2%
1/16 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
General disorders
anorexia
|
6.2%
1/16 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
General disorders
anxiety
|
6.2%
1/16 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
|
Musculoskeletal and connective tissue disorders
backache
|
0.00%
0/16 • Over 12 weeks of trial or length of participant's participation
|
6.7%
1/15 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
|
General disorders
chills
|
0.00%
0/16 • Over 12 weeks of trial or length of participant's participation
|
6.7%
1/15 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
|
Gastrointestinal disorders
constipation
|
18.8%
3/16 • Number of events 3 • Over 12 weeks of trial or length of participant's participation
|
20.0%
3/15 • Number of events 3 • Over 12 weeks of trial or length of participant's participation
|
|
General disorders
concentration issues
|
6.2%
1/16 • Number of events 1 • Over 12 weeks of trial or length of participant's participation
|
0.00%
0/15 • Over 12 weeks of trial or length of participant's participation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place