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Clonidine to Treat Iatrogenic-induced Opioid Dependence in Infants

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ClinicalTrials.gov Identifier: NCT01360450
Recruitment Status : Terminated (The study was treminated because of low accural)
First Posted : May 25, 2011
Results First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Neonatal Abstinence Syndrome
Interventions Drug: Clonidine HCL
Drug: saline
Enrollment 12

Recruitment Details

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

Pre-assignment Details All patients who were enrolled participated in the study.
Arm/Group Title Treatment Control
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 6 6
Completed Treatment 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title Treatment Control Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
The gestational age of the infant and the birth weight were collected as baseline measurements
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
<=18 years
6
 100.0%
6
 100.0%
12
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
3
  50.0%
4
  66.7%
7
  58.3%
Male
3
  50.0%
2
  33.3%
5
  41.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  16.7%
1
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
3
  50.0%
3
  25.0%
White
6
 100.0%
1
  16.7%
7
  58.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
  16.7%
1
   8.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 12 participants
6 6 12
Birth Weight  
Mean (Standard Deviation)
Unit of measure:  Grams
Number Analyzed 6 participants 6 participants 12 participants
3084  (0.59) 3250  (0.9) 3160  (0.76)
1.Primary Outcome
Title Time to Complete Detoxification
Hide Description 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.
Time Frame up to 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: days
total days on narcotics 89.5  (137) 37.2  (10)
duration on study drug in days 21  (18.1) 14.2  (8.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments yes the P value was adjusted for multiple comparisons.
Method ANOVA
Comments 2 sided ANOVA
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Estimation Comments Mean difference between the two treatment arms
2.Secondary Outcome
Title Cardiovascular Side-effects Changes HR and BP
Hide Description Changes in Heart Rate (HR) and BP for 48 hrs after starting study drug and for 48hrs after stopping study drug
Time Frame 48 hrs after starting study drug and for 48hrs after stopping study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data is available for this outcome measure, as it was not collected.
Arm/Group Title Treatment Control
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Cumulative Dose of Opioid and Benzodiazepine
Hide Description We will determine the total amount of opioid and benzodiazepine needed from the start of detoxification to the end of the the detoxification.
Time Frame 2-4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data is available for this outcome measure, as it was not collected.
Arm/Group Title Treatment Control
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame up to 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Control
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Treatment Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)