Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome

Phase 2

Completed

• Conditions: Neonatal Abstinence Syndrome
• Interventions: Drug: Clonidine HCL

• Registration Number: NCT00510016
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Study Completion: 2005-12
• Status Verified: 2007-07
• Study First Submitted: 2007-07-31
• Study First Submitted QC: 2007-07-31
• Study First Posted: 2007-08-01
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clonidine treatment	Clonidine HCL	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.

Primary Outcome Measures

Name	Time	Method
Length of treatment for neonatal abstinence syndrome	duration of the treatment

Trial Locations

Locations (1)

Johns Hopkins Medical Institutions; 🇺🇸 Baltimore, Maryland, United States