Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome (NAS)

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Neonatal Abstinence Syndrome

Treatments: Drug: Clonidine HCL

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00510016

1R21DA016288-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: Under 14 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 1 patient group

Clonidine treatment

Experimental group

Description:

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.

Treatment:

Drug: Clonidine HCL