Trial Outcomes & Findings for Evaluation of Buprenorphine Extended-Release Subcutaneous Injection at Alternative Injection Locations (NCT NCT05704543)
NCT ID: NCT05704543
Last Updated: 2025-01-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
132 participants
Primary outcome timeframe
Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29
Results posted on
2025-01-07
Participant Flow
A total of 175 participants were screened to assess eligibility; of these, 132 received SUBOXONE during the Run-In Period (all eligible participants were attempted to be stabilized on 12 mg SUBOXONE \[buprenorphine/naloxone\] sublingual film once daily for a minimum of 7 days before the SUBLOCADE injection). 44 participants discontinued during the Run-In Period. A total of 88 participants were thus randomized (Started) to a treatment arm to receive extended-release buprenorphine on Day 1.
Participant milestones
| Measure |
Extended-release Buprenorphine: Abdomen
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Upper Arm
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Buttocks
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Thigh
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
22
|
23
|
|
Overall Study
COMPLETED
|
20
|
18
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
0
|
2
|
Reasons for withdrawal
| Measure |
Extended-release Buprenorphine: Abdomen
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Upper Arm
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Buttocks
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Thigh
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
0
|
Baseline Characteristics
Evaluation of Buprenorphine Extended-Release Subcutaneous Injection at Alternative Injection Locations
Baseline characteristics by cohort
| Measure |
Extended-release Buprenorphine: Abdomen
n=22 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Upper Arm
n=21 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Buttocks
n=22 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Thigh
n=23 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 10.35 • n=5 Participants
|
43.9 years
STANDARD_DEVIATION 9.61 • n=7 Participants
|
45.6 years
STANDARD_DEVIATION 8.94 • n=5 Participants
|
36.7 years
STANDARD_DEVIATION 7.89 • n=4 Participants
|
41.2 years
STANDARD_DEVIATION 9.77 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
22 participants
n=5 Participants
|
23 participants
n=4 Participants
|
88 participants
n=21 Participants
|
|
Body mass index
|
26.87 kg/m^2
STANDARD_DEVIATION 4.698 • n=5 Participants
|
25.95 kg/m^2
STANDARD_DEVIATION 5.011 • n=7 Participants
|
26.06 kg/m^2
STANDARD_DEVIATION 4.259 • n=5 Participants
|
26.30 kg/m^2
STANDARD_DEVIATION 4.500 • n=4 Participants
|
26.30 kg/m^2
STANDARD_DEVIATION 4.552 • n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29Population: Pharmacokinetic Evaluable Analysis Set
Outcome measures
| Measure |
Extended-release Buprenorphine: Abdomen
n=22 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Upper Arm
n=17 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Buttocks
n=22 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Thigh
n=21 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine
|
1640 h*ng/mL
Geometric Coefficient of Variation 41.8
|
1720 h*ng/mL
Geometric Coefficient of Variation 57.4
|
1570 h*ng/mL
Geometric Coefficient of Variation 42.7
|
1870 h*ng/mL
Geometric Coefficient of Variation 56.2
|
PRIMARY outcome
Timeframe: Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29Population: Pharmacokinetic Evaluable Analysis Set
Outcome measures
| Measure |
Extended-release Buprenorphine: Abdomen
n=22 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Upper Arm
n=20 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Buttocks
n=22 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Thigh
n=21 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Buprenorphine
|
6.61 ng/mL
Geometric Coefficient of Variation 46.9
|
9.17 ng/mL
Geometric Coefficient of Variation 85.8
|
7.11 ng/mL
Geometric Coefficient of Variation 39.7
|
10.1 ng/mL
Geometric Coefficient of Variation 73.2
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Safety Analysis Set
Outcome measures
| Measure |
Extended-release Buprenorphine: Abdomen
n=22 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Upper Arm
n=21 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Buttocks
n=22 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Thigh
n=23 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
|---|---|---|---|---|
|
Participants With Treatment-emergent Adverse Events
TEAE identified as injection site reaction
|
9.1 Percentage of participants
|
4.8 Percentage of participants
|
4.5 Percentage of participants
|
4.3 Percentage of participants
|
|
Participants With Treatment-emergent Adverse Events
Related TEAE
|
9.1 Percentage of participants
|
4.8 Percentage of participants
|
13.6 Percentage of participants
|
4.3 Percentage of participants
|
|
Participants With Treatment-emergent Adverse Events
Any treatment-emergent adverse event (TEAE)
|
22.7 Percentage of participants
|
14.3 Percentage of participants
|
18.2 Percentage of participants
|
8.7 Percentage of participants
|
|
Participants With Treatment-emergent Adverse Events
Severe TEAE
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Participants With Treatment-emergent Adverse Events
TEAE of opioid withdrawal symptom
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Participants With Treatment-emergent Adverse Events
TEAE leading to death
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Safety Analysis Set
Outcome measures
| Measure |
Extended-release Buprenorphine: Abdomen
n=22 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Upper Arm
n=21 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Buttocks
n=22 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Thigh
n=23 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events Identified as Injection Site Reactions
Injection site erythema
|
4.5 Percentage of participants
|
0 Percentage of participants
|
4.5 Percentage of participants
|
0 Percentage of participants
|
|
Number of Participants With Treatment-emergent Adverse Events Identified as Injection Site Reactions
Injection site induration
|
0 Percentage of participants
|
4.8 Percentage of participants
|
4.5 Percentage of participants
|
0 Percentage of participants
|
|
Number of Participants With Treatment-emergent Adverse Events Identified as Injection Site Reactions
Injection site pain
|
4.5 Percentage of participants
|
4.8 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Number of Participants With Treatment-emergent Adverse Events Identified as Injection Site Reactions
Injection site swelling
|
0 Percentage of participants
|
4.8 Percentage of participants
|
0 Percentage of participants
|
4.3 Percentage of participants
|
|
Number of Participants With Treatment-emergent Adverse Events Identified as Injection Site Reactions
Injection site reaction
|
4.5 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Safety Analysis Set
Outcome measures
| Measure |
Extended-release Buprenorphine: Abdomen
n=22 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Upper Arm
n=21 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Buttocks
n=22 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Thigh
n=23 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Serious Adverse Events
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 at 10 minutes and 2 hours post dosingPopulation: Safety Analysis Set
Injection sites will be assessed for pain, tenderness, erythema/redness, induration, or swelling. Local injection site tolerability will be assigned a severity grade, including none (grade 0), mild (grade 1), moderate (grade 2), severe (grade 3), or potentially life-threatening (grade 4) utilizing the Injection Site Grading Scale.
Outcome measures
| Measure |
Extended-release Buprenorphine: Abdomen
n=22 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Upper Arm
n=21 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Buttocks
n=22 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Thigh
n=23 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
|---|---|---|---|---|
|
Injection Site Grading
Tenderness, None (Grade 0) at 10 minutes
|
59.1 Percentage of participants
|
66.7 Percentage of participants
|
77.3 Percentage of participants
|
56.5 Percentage of participants
|
|
Injection Site Grading
Tenderness, Mild (Grade 1) at 10 minutes
|
31.8 Percentage of participants
|
33.3 Percentage of participants
|
22.7 Percentage of participants
|
39.1 Percentage of participants
|
|
Injection Site Grading
Induration, Mild (Grade 1) at 10 minutes
|
4.5 Percentage of participants
|
14.3 Percentage of participants
|
4.5 Percentage of participants
|
13.0 Percentage of participants
|
|
Injection Site Grading
Pain, None (Grade 0) at 10 minutes
|
59.1 Percentage of participants
|
57.1 Percentage of participants
|
68.2 Percentage of participants
|
56.5 Percentage of participants
|
|
Injection Site Grading
Pain, Mild (Grade 1) at 10 minutes
|
31.8 Percentage of participants
|
28.6 Percentage of participants
|
18.2 Percentage of participants
|
34.8 Percentage of participants
|
|
Injection Site Grading
Pain, Moderate (Grade 2) at 10 minutes
|
9.1 Percentage of participants
|
14.3 Percentage of participants
|
13.6 Percentage of participants
|
8.7 Percentage of participants
|
|
Injection Site Grading
Tenderness, Moderate (Grade 2) at 10 minutes
|
9.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
4.3 Percentage of participants
|
|
Injection Site Grading
Erythema/redness, None (Grade 0) at 10 minutes
|
86.4 Percentage of participants
|
81.0 Percentage of participants
|
86.4 Percentage of participants
|
100.0 Percentage of participants
|
|
Injection Site Grading
Erythema/redness, Mild (Grade 1) at 10 minutes
|
13.6 Percentage of participants
|
19.0 Percentage of participants
|
13.6 Percentage of participants
|
0 Percentage of participants
|
|
Injection Site Grading
Induration, None (Grade 0) at 10 minutes
|
95.5 Percentage of participants
|
85.7 Percentage of participants
|
95.5 Percentage of participants
|
87.0 Percentage of participants
|
|
Injection Site Grading
Injection site swelling, None (Grade 0) at 10 minutes
|
90.9 Percentage of participants
|
85.7 Percentage of participants
|
90.9 Percentage of participants
|
82.6 Percentage of participants
|
|
Injection Site Grading
Injection site swelling, Mild (Grade 1) at 10 minutes
|
9.1 Percentage of participants
|
14.3 Percentage of participants
|
9.1 Percentage of participants
|
17.4 Percentage of participants
|
|
Injection Site Grading
Pain, None (Grade 0) at 2 hours
|
100.0 Percentage of participants
|
81.0 Percentage of participants
|
90.9 Percentage of participants
|
91.3 Percentage of participants
|
|
Injection Site Grading
Pain, Mild (Grade 1) at 2 hours
|
0 Percentage of participants
|
19.0 Percentage of participants
|
9.1 Percentage of participants
|
8.7 Percentage of participants
|
|
Injection Site Grading
Tenderness, None (Grade 0) at 2 hours
|
86.4 Percentage of participants
|
81.0 Percentage of participants
|
95.5 Percentage of participants
|
91.3 Percentage of participants
|
|
Injection Site Grading
Tenderness, Mild (Grade 1) at 2 hours
|
13.6 Percentage of participants
|
19.0 Percentage of participants
|
4.5 Percentage of participants
|
8.7 Percentage of participants
|
|
Injection Site Grading
Erythema/redness, None (Grade 0) at 2 hours
|
95.5 Percentage of participants
|
90.5 Percentage of participants
|
95.5 Percentage of participants
|
100.0 Percentage of participants
|
|
Injection Site Grading
Erythema/redness, Mild (Grade 1) at 2 hours
|
4.5 Percentage of participants
|
9.5 Percentage of participants
|
4.5 Percentage of participants
|
0 Percentage of participants
|
|
Injection Site Grading
Induration, None (Grade 0) at 2 hours
|
86.4 Percentage of participants
|
81.0 Percentage of participants
|
95.5 Percentage of participants
|
95.7 Percentage of participants
|
|
Injection Site Grading
Induration, Mild (Grade 1) at 2 hours
|
13.6 Percentage of participants
|
19.0 Percentage of participants
|
4.5 Percentage of participants
|
4.3 Percentage of participants
|
|
Injection Site Grading
Injection site swelling, None (Grade 0) at 2 hours
|
95.5 Percentage of participants
|
85.7 Percentage of participants
|
90.9 Percentage of participants
|
87.0 Percentage of participants
|
|
Injection Site Grading
Injection site swelling, Mild (Grade 1) at 2 hours
|
4.5 Percentage of participants
|
14.3 Percentage of participants
|
9.1 Percentage of participants
|
13.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 at 1, 5, 10, 15, and 30 minutes post dosingPopulation: Safety Analysis Set
Measured on a 100 mm visual analog scale (VAS), where 0 represents no pain and 100 represents maximum pain.
Outcome measures
| Measure |
Extended-release Buprenorphine: Abdomen
n=22 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Upper Arm
n=21 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Buttocks
n=22 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Thigh
n=23 Participants
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
|---|---|---|---|---|
|
Injection Site Pain
5 minutes
|
23.2 score on a scale
Standard Deviation 26.13
|
16.0 score on a scale
Standard Deviation 16.59
|
13.6 score on a scale
Standard Deviation 23.62
|
19.0 score on a scale
Standard Deviation 23.56
|
|
Injection Site Pain
30 minutes
|
1.8 score on a scale
Standard Deviation 2.56
|
4.5 score on a scale
Standard Deviation 8.69
|
1.4 score on a scale
Standard Deviation 2.46
|
6.6 score on a scale
Standard Deviation 19.93
|
|
Injection Site Pain
1 minute
|
37.5 score on a scale
Standard Deviation 27.95
|
29.0 score on a scale
Standard Deviation 24.10
|
27.4 score on a scale
Standard Deviation 32.02
|
29.3 score on a scale
Standard Deviation 28.99
|
|
Injection Site Pain
10 minutes
|
12.0 score on a scale
Standard Deviation 14.88
|
9.4 score on a scale
Standard Deviation 11.80
|
8.2 score on a scale
Standard Deviation 14.15
|
12.5 score on a scale
Standard Deviation 21.30
|
|
Injection Site Pain
15 minutes
|
4.8 score on a scale
Standard Deviation 6.58
|
6.0 score on a scale
Standard Deviation 8.76
|
4.9 score on a scale
Standard Deviation 11.80
|
8.6 score on a scale
Standard Deviation 20.64
|
Adverse Events
Pre-injection (Run-In Period)
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Extended-release Buprenorphine: Abdomen (Post-injection)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Extended-release Buprenorphine: Upper Arm (Post-injection)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Extended-release Buprenorphine: Buttocks (Post-injection)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Extended-release Buprenorphine: Thigh (Post-injection)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pre-injection (Run-In Period)
n=132 participants at risk
Participants who received SUBOXONE during the Run-In Period (all eligible participants were attempted to be stabilized on 12 mg SUBOXONE \[buprenorphine/naloxone\] sublingual film once daily for a minimum of 7 days before injection with extended-release buprenorphine). 44 participants discontinued during the Run-In Period.
|
Extended-release Buprenorphine: Abdomen (Post-injection)
n=22 participants at risk
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Upper Arm (Post-injection)
n=21 participants at risk
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Buttocks (Post-injection)
n=22 participants at risk
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
Extended-release Buprenorphine: Thigh (Post-injection)
n=23 participants at risk
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.
Buprenorphine Extended-Release Injection: Administered as a subcutaneous injection.
|
|---|---|---|---|---|---|
|
General disorders
General disorders and administration site conditions
|
1.5%
2/132 • Up to 86 days
|
9.1%
2/22 • Up to 86 days
|
9.5%
2/21 • Up to 86 days
|
4.5%
1/22 • Up to 86 days
|
4.3%
1/23 • Up to 86 days
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
10.6%
14/132 • Up to 86 days
|
0.00%
0/22 • Up to 86 days
|
4.8%
1/21 • Up to 86 days
|
4.5%
1/22 • Up to 86 days
|
0.00%
0/23 • Up to 86 days
|
|
Infections and infestations
Infections and infestations
|
3.0%
4/132 • Up to 86 days
|
9.1%
2/22 • Up to 86 days
|
0.00%
0/21 • Up to 86 days
|
0.00%
0/22 • Up to 86 days
|
0.00%
0/23 • Up to 86 days
|
|
Investigations
Investigations
|
0.76%
1/132 • Up to 86 days
|
0.00%
0/22 • Up to 86 days
|
0.00%
0/21 • Up to 86 days
|
4.5%
1/22 • Up to 86 days
|
4.3%
1/23 • Up to 86 days
|
|
Immune system disorders
Immune system disorders
|
0.00%
0/132 • Up to 86 days
|
0.00%
0/22 • Up to 86 days
|
0.00%
0/21 • Up to 86 days
|
4.5%
1/22 • Up to 86 days
|
0.00%
0/23 • Up to 86 days
|
|
Nervous system disorders
Nervous system disorders
|
4.5%
6/132 • Up to 86 days
|
4.5%
1/22 • Up to 86 days
|
0.00%
0/21 • Up to 86 days
|
0.00%
0/22 • Up to 86 days
|
0.00%
0/23 • Up to 86 days
|
|
Psychiatric disorders
Psychiatric disorders
|
4.5%
6/132 • Up to 86 days
|
0.00%
0/22 • Up to 86 days
|
0.00%
0/21 • Up to 86 days
|
0.00%
0/22 • Up to 86 days
|
0.00%
0/23 • Up to 86 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place