Trial Outcomes & Findings for Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure (NCT NCT03608696)
NCT ID: NCT03608696
Last Updated: 2022-02-11
Results Overview
Goal is to define buprenorphine pharmacokinetic exposure (Area under the plasma concentration versus time curve (AUC)) in infants treated with buprenorphine for neonatal abstinence syndrome (NAS) using a model-based optimized dose.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Duration of pharmacologic treatment for neonatal abstinence syndrome up to 70 days of age
Results posted on
2022-02-11
Participant Flow
Participant milestones
| Measure |
Buprenorphine
Buprenorphine 0.075 mg ml sublingual solution
Initial daily dose 24 mcg/kg/day Initial unit dose 8 mcg/kg q8 hours Maximum daily dose 75 mcg/kg/day Maximum unit dose 25 mcg/kg q8 hours Up-titration rate 33% Maximum # of up-titrations 4 Weaning rate 15% Cessation (bottom) dose \< Initial dose Dosing interval until bottom dose (hrs) 8 Dose interval extension #1 at bottom dose (hrs) 12 Dose interval extension #2 at bottom dose (hrs) 24
Buprenorphine: buprenorphine 0.075 mg/ml solution
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure
Baseline characteristics by cohort
| Measure |
Buprenorphine
n=10 Participants
Buprenorphine 0.075 mg ml sublingual solution
Initial daily dose 24 mcg/kg/day Initial unit dose 8 mcg/kg q8 hours Maximum daily dose 75 mcg/kg/day Maximum unit dose 25 mcg/kg q8 hours Up-titration rate 33% Maximum # of up-titrations 4 Weaning rate 15% Cessation (bottom) dose \< Initial dose Dosing interval until bottom dose (hrs) 8 Dose interval extension #1 at bottom dose (hrs) 12 Dose interval extension #2 at bottom dose (hrs) 24
Buprenorphine: buprenorphine 0.075 mg/ml solution
|
|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25.5 days
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 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: Duration of pharmacologic treatment for neonatal abstinence syndrome up to 70 days of agePopulation: N/A (PK data was not usable as analyzed for this study as most was below the limit of quantification.)
Goal is to define buprenorphine pharmacokinetic exposure (Area under the plasma concentration versus time curve (AUC)) in infants treated with buprenorphine for neonatal abstinence syndrome (NAS) using a model-based optimized dose.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of pharmacologic treatment for neonatal abstinence syndrome, up to 70 days of agePopulation: Adverse events in study population
The number of participants with treatment related adverse events
Outcome measures
| Measure |
Buprenorphine
n=10 Participants
Buprenorphine 0.075 mg ml sublingual solution
Initial daily dose 24 mcg/kg/day Initial unit dose 8 mcg/kg q8 hours Maximum daily dose 75 mcg/kg/day Maximum unit dose 25 mcg/kg q8 hours Up-titration rate 33% Maximum # of up-titrations 4 Weaning rate 15% Cessation (bottom) dose \< Initial dose Dosing interval until bottom dose (hrs) 8 Dose interval extension #1 at bottom dose (hrs) 12 Dose interval extension #2 at bottom dose (hrs) 24
Buprenorphine: buprenorphine 0.075 mg/ml solution
|
|---|---|
|
Number of Participants With Treatment Related Adverse Events
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of pharmacologic treatment for neonatal abstinence syndrome up to 70 days of ageLength of treatment with buprenrophine for NAS (hours) of a model-based optimized dose of buprenorphine for infants treated for NAS.
Outcome measures
| Measure |
Buprenorphine
n=10 Participants
Buprenorphine 0.075 mg ml sublingual solution
Initial daily dose 24 mcg/kg/day Initial unit dose 8 mcg/kg q8 hours Maximum daily dose 75 mcg/kg/day Maximum unit dose 25 mcg/kg q8 hours Up-titration rate 33% Maximum # of up-titrations 4 Weaning rate 15% Cessation (bottom) dose \< Initial dose Dosing interval until bottom dose (hrs) 8 Dose interval extension #1 at bottom dose (hrs) 12 Dose interval extension #2 at bottom dose (hrs) 24
Buprenorphine: buprenorphine 0.075 mg/ml solution
|
|---|---|
|
Length of Treatment
|
30 days
Standard Deviation 8.6
|
Adverse Events
Buprenorphine
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Buprenorphine
n=10 participants at risk
Buprenorphine 0.075 mg ml sublingual solution
Initial daily dose 24 mcg/kg/day Initial unit dose 8 mcg/kg q8 hours Maximum daily dose 75 mcg/kg/day Maximum unit dose 25 mcg/kg q8 hours Up-titration rate 33% Maximum # of up-titrations 4 Weaning rate 15% Cessation (bottom) dose \< Initial dose Dosing interval until bottom dose (hrs) 8 Dose interval extension #1 at bottom dose (hrs) 12 Dose interval extension #2 at bottom dose (hrs) 24
Buprenorphine: buprenorphine 0.075 mg/ml solution
|
|---|---|
|
Nervous system disorders
seizure
|
10.0%
1/10 • Number of events 1 • Adverse events were collected until infants were discharged from the hospital, an average of 30 days (range 11-42)
definition of SAE matches that of clinicaltrials.gov
|
Other adverse events
| Measure |
Buprenorphine
n=10 participants at risk
Buprenorphine 0.075 mg ml sublingual solution
Initial daily dose 24 mcg/kg/day Initial unit dose 8 mcg/kg q8 hours Maximum daily dose 75 mcg/kg/day Maximum unit dose 25 mcg/kg q8 hours Up-titration rate 33% Maximum # of up-titrations 4 Weaning rate 15% Cessation (bottom) dose \< Initial dose Dosing interval until bottom dose (hrs) 8 Dose interval extension #1 at bottom dose (hrs) 12 Dose interval extension #2 at bottom dose (hrs) 24
Buprenorphine: buprenorphine 0.075 mg/ml solution
|
|---|---|
|
Skin and subcutaneous tissue disorders
rash
|
10.0%
1/10 • Number of events 1 • Adverse events were collected until infants were discharged from the hospital, an average of 30 days (range 11-42)
definition of SAE matches that of clinicaltrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place