Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial

National Institute on Drug Abuse (NIDA)1 site in 1 country80 target enrollmentJuly 2002

ConditionsNeonatal Abstinence Syndrome

InterventionsClonidine HCL

DrugsClonidine HCL

Overview

Phase: Phase 2
Intervention: Clonidine HCL
Conditions: Neonatal Abstinence Syndrome
Sponsor: National Institute on Drug Abuse (NIDA)
Enrollment: 80
Locations: 1
Primary Endpoint: Length of treatment for neonatal abstinence syndrome
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.

Registry

clinicaltrials.gov

Start Date

July 2002

End Date

December 2005

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National Institute on Drug Abuse (NIDA)

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•\< 35 weeks gestational age
•Intrauterine growth retardation defined as \<5%tile of gestational age
•postnatal treatment with barbiturates or benzodiazepines,
•major congenital anomalies
•major concomitant medical illness requiring oxygen therapy, intravenous fluids or medications.
•breastfed infants

Arms & Interventions

Clonidine treatment

Infants intrauterine exposed to opioids (heroin or methadone) that demonstrate signs and symptoms of withdrawal with withdrawal scores (modified Finnegan score) greater than 9 on to consecutive scores taken 4 hours apart.

Intervention: Clonidine HCL