Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00510016

Acronym

NAS

Enrollment

Registered

2007-08-01

Start date

2002-07-31

Completion date

2005-12-31

Last updated

2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Abstinence Syndrome

Keywords

infants, opioid withdrawal, abstinence syndrome, methadone, heroin

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.

Interventions

DRUGClonidine HCL

Duraclon 1 microgram/kg every 4 hours given p.o. as per algorithm

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

No minimum to 14 Days

Healthy volunteers

Inclusion criteria

* neonates born at gestational age of 35 weeks or greater * neonates aged 0 to 14 days * prenatally exposed to opioids * severe NAS defined as 2 consecutive modified Finnegan Scores (MFS) \> or = 9

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

Design outcomes

Primary

Measure	Time frame
Length of treatment for neonatal abstinence syndrome	duration of the treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026