Trial Outcomes & Findings for Clonidine to Treat Iatrogenic-induced Opioid Dependence in Infants (NCT NCT01360450)
NCT ID: NCT01360450
Last Updated: 2017-09-13
Results Overview
Time to complete detoxification is defined as 48 hrs off all opioids/benzodiazepines and study drug with acceptable withdrawal scores of \<9 (on average we expect the infant to be enrolled in the study for 2-4 weeks). The scale used to assess withdrawal was the Modified Finnegan Neonatal Withdrawal Scale, which ranges from 0-41, 0 represents no withdrawal and 41 represent maximum withdrawal.
TERMINATED
PHASE2/PHASE3
12 participants
up to 4 weeks
2017-09-13
Participant Flow
Infants recruited from the Neonatal Intensive Unit (NICU) and Pediatric Intensive Unit (PICU) at Johns Hopkins Hospital within 5 days of birth who needed sedation and analgesia as part of treatment. Recruitment period was from July 2011 to July 2014. Accrual was very low
All patients who were enrolled participated in the study.
Participant milestones
| Measure |
Treatment
Infants will receive intravenous or oral clonidine(Duraclon) for the treatment of pain and sedation
Clonidine Hydrochloride: At day 5 on opioid and/or benzodiazepine (BZD), the infant will be randomized to receive either placebo (normal saline) or clonidine 1μg/kg/q 4 hrs to a maximum dose of 2μg/kg/q 4. Weaning from the study drug: When the opioid is no longer required, 24 hrs later the study drug (placebo or study drug) will be reduced by 50% and then discontinued 24 hours later provided that the Modified Finnegan scores remain between \< 9.
|
Control
Infants will receive place (saline) (if receiving it IV) or orally (sterile water) if receiving it orally
saline: Infants randomized to placebo will be administered IV saline or oral sterile water in the same volume as study drug. The placebo will be give every 4 hrs as outlined in the algorithm for the study.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
Completed Treatment
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clonidine to Treat Iatrogenic-induced Opioid Dependence in Infants
Baseline characteristics by cohort
| Measure |
Treatment
n=6 Participants
Infants will receive intravenous or oral clonidine(Duraclon) for the treatment of pain and sedation
Clonidine HCL: At day 5 on opioid and/or benzodiazepine (BZD), the infant will be randomized to receive either placebo (normal saline) or clonidine 1μg/kg/q 4 hrs to a maximum dose of 2μg/kg/q 4. Weaning from the study drug: When the opioid is no longer required, 24 hrs later the study drug (placebo or study drug) will be reduced by 50% and then discontinued 24 hours later provided that the Modified Finnegan scores remain between \< 9.
|
Control
n=6 Participants
Infants will receive place (saline) (if receiving it IV) or orally (sterile water) if receiving it orally
saline: Infants randomized to placebo will be administered IV saline or oral sterile water in the same volume as study drug. The placebo will be give every 4 hrs as outlined in the algorithm for the study.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=39 Participants
|
6 participants
n=41 Participants
|
12 participants
n=35 Participants
|
|
Birth Weight
|
3084 grams
STANDARD_DEVIATION 0.59 • n=39 Participants
|
3250 grams
STANDARD_DEVIATION 0.9 • n=41 Participants
|
3160 grams
STANDARD_DEVIATION 0.76 • n=35 Participants
|
PRIMARY outcome
Timeframe: up to 4 weeksTime to complete detoxification is defined as 48 hrs off all opioids/benzodiazepines and study drug with acceptable withdrawal scores of \<9 (on average we expect the infant to be enrolled in the study for 2-4 weeks). The scale used to assess withdrawal was the Modified Finnegan Neonatal Withdrawal Scale, which ranges from 0-41, 0 represents no withdrawal and 41 represent maximum withdrawal.
Outcome measures
| Measure |
Treatment
n=6 Participants
Infants will receive intravenous or oral clonidine(Duraclon) for the treatment of pain and sedation
Clonidine HCL: At day 5 on opioid and/or benzodiazepine (BZD), the infant will be randomized to receive either placebo (normal saline) or clonidine 1μg/kg/q 4 hrs to a maximum dose of 2μg/kg/q 4. Weaning from the study drug: When the opioid is no longer required, 24 hrs later the study drug (placebo or study drug) will be reduced by 50% and then discontinued 24 hours later provided that the Modified Finnegan scores remain between \< 9.
|
Control
n=6 Participants
Infants will receive place (saline) (if receiving it IV) or orally (sterile water) if receiving it orally
saline: Infants randomized to placebo will be administered IV saline or oral sterile water in the same volume as study drug. The placebo will be give every 4 hrs as outlined in the algorithm for the study.
|
|---|---|---|
|
Time to Complete Detoxification
total days on narcotics
|
89.5 days
Standard Deviation 137
|
37.2 days
Standard Deviation 10
|
|
Time to Complete Detoxification
duration on study drug in days
|
21 days
Standard Deviation 18.1
|
14.2 days
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 48 hrs after starting study drug and for 48hrs after stopping study drugPopulation: No data is available for this outcome measure, as it was not collected.
Changes in Heart Rate (HR) and BP for 48 hrs after starting study drug and for 48hrs after stopping study drug
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2-4 weeksPopulation: No data is available for this outcome measure, as it was not collected.
We will determine the total amount of opioid and benzodiazepine needed from the start of detoxification to the end of the the detoxification.
Outcome measures
Outcome data not reported
Adverse Events
Treatment
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place