Trial Outcomes & Findings for An Open-Label Pilot Study of Sublocade as Treatment for Opiate Use Disorder (NCT NCT03861338)
NCT ID: NCT03861338
Last Updated: 2021-03-09
Results Overview
Number of participants successfully inducted onto Sublocade (BXR)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Study week 1
Results posted on
2021-03-09
Participant Flow
10 of the 11 enrolled participants initiated the oral Buprenorphine induction process. 1 participant did not initiate the induction process following consent.
Participant milestones
| Measure |
Sublocade
Sublocade buprenorphine extended-release (BXR) injection, 300 mg and 100 mg
Sublocade: The monthly Sublocade buprenorphine extended-release (BXR) injection will be administered in two doses (100 mg and 300 mg). Following a 4 day induction onto oral buprenorphine, the first 300 mg injection of Sublocade will be administered. A second 300 mg Sublocade injection will be administered 1 month later and the third and final monthly injection of 100 mg of Sublocade will be administered 2 months post the successful buprenorphine induction.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-Label Pilot Study of Sublocade as Treatment for Opiate Use Disorder
Baseline characteristics by cohort
| Measure |
Sublocade
n=10 Participants
Sublocade buprenorphine extended-release (BXR) injection, 300 mg and 100 mg
Sublocade: The monthly Sublocade buprenorphine extended-release (BXR) injection will be administered in two doses (100 mg and 300 mg). Following a 4 day induction onto oral buprenorphine, the first 300 mg injection of Sublocade will be administered. A second 300 mg Sublocade injection will be administered 1 month later and the third and final monthly injection of 100 mg of Sublocade will be administered 2 months post the successful buprenorphine induction.
|
|---|---|
|
Age, Continuous
|
37.4 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study week 1Number of participants successfully inducted onto Sublocade (BXR)
Outcome measures
| Measure |
Sublocade
n=10 Participants
Sublocade buprenorphine extended-release (BXR) injection, 300 mg and 100 mg
Sublocade: The monthly Sublocade buprenorphine extended-release (BXR) injection will be administered in two doses (100 mg and 300 mg). Following a 4 day induction onto oral buprenorphine, the first 300 mg injection of Sublocade will be administered. A second 300 mg Sublocade injection will be administered 1 month later and the third and final monthly injection of 100 mg of Sublocade will be administered 2 months post the successful buprenorphine induction.
|
|---|---|
|
Sublocade Induction
|
10 Participants
|
Adverse Events
Sublocade
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sublocade
n=10 participants at risk
Sublocade buprenorphine extended-release (BXR) injection, 300 mg and 100 mg
Sublocade: The monthly Sublocade buprenorphine extended-release (BXR) injection will be administered in two doses (100 mg and 300 mg). Following a 4 day induction onto oral buprenorphine, the first 300 mg injection of Sublocade will be administered. A second 300 mg Sublocade injection will be administered 1 month later and the third and final monthly injection of 100 mg of Sublocade will be administered 2 months post the successful buprenorphine induction.
|
|---|---|
|
General disorders
opioid withdrawal
|
90.0%
9/10 • Number of events 9 • 12 weeks of study
|
|
Gastrointestinal disorders
anorexia
|
20.0%
2/10 • Number of events 2 • 12 weeks of study
|
|
Eye disorders
blurred vision
|
10.0%
1/10 • Number of events 1 • 12 weeks of study
|
|
Gastrointestinal disorders
constipation
|
10.0%
1/10 • Number of events 1 • 12 weeks of study
|
|
Psychiatric disorders
depression
|
10.0%
1/10 • Number of events 1 • 12 weeks of study
|
|
Nervous system disorders
difficulties with memory
|
10.0%
1/10 • Number of events 1 • 12 weeks of study
|
|
General disorders
fever
|
10.0%
1/10 • Number of events 1 • 12 weeks of study
|
|
General disorders
headache
|
20.0%
2/10 • Number of events 2 • 12 weeks of study
|
|
General disorders
loss of libido
|
10.0%
1/10 • Number of events 1 • 12 weeks of study
|
|
Nervous system disorders
tremor
|
10.0%
1/10 • Number of events 1 • 12 weeks of study
|
|
Metabolism and nutrition disorders
increase in weight
|
10.0%
1/10 • Number of events 1 • 12 weeks of study
|
|
General disorders
toothache
|
10.0%
1/10 • Number of events 1 • 12 weeks of study
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
30.0%
3/10 • Number of events 3 • 12 weeks of study
|
|
Endocrine disorders
elevated liver functions
|
10.0%
1/10 • Number of events 1 • 12 weeks of study
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
1/10 • Number of events 1 • 12 weeks of study
|
|
Respiratory, thoracic and mediastinal disorders
pharyngitis
|
10.0%
1/10 • Number of events 1 • 12 weeks of study
|
|
Respiratory, thoracic and mediastinal disorders
sinusitis
|
10.0%
1/10 • Number of events 1 • 12 weeks of study
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
10.0%
1/10 • Number of events 1 • 12 weeks of study
|
|
Skin and subcutaneous tissue disorders
injection site pain
|
30.0%
3/10 • Number of events 3 • 12 weeks of study
|
|
Skin and subcutaneous tissue disorders
pruritis
|
20.0%
2/10 • Number of events 2 • 12 weeks of study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place