ClinicalTrials.gov
ClinicalTrials.gov Menu

Clonidine to Treat Iatrogenic-induced Opioid Dependence in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients who were enrolled participated in the study.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Treatment   Control
STARTED   6   6 
Completed Treatment   6   6 
COMPLETED   6   6 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The gestational age of the infant and the birth weight were collected as baseline measurements

Reporting Groups
  Description
Treatment

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

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 Total of all reporting groups

Baseline Measures
   Treatment   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   12 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      3  50.0%      4  66.7%      7  58.3% 
Male      3  50.0%      2  33.3%      5  41.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   6   6   12 
Birth Weight 
[Units: Grams]
Mean (Standard Deviation)
 3084  (0.59)   3250  (0.9)   3160  (0.76) 


  Outcome Measures

1.  Primary:   Time to Complete Detoxification   [ Time Frame: up to 4 weeks ]

2.  Secondary:   Cardiovascular Side-effects Changes HR and BP   [ Time Frame: 48 hrs after starting study drug and for 48hrs after stopping study drug ]

3.  Secondary:   Cumulative Dose of Opioid and Benzodiazepine   [ Time Frame: 2-4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.