Recruiting
Phase 1
Phase 2

Buprenorphine with Clonidine

Sponsor:

Gauda, Estelle B., M.D.

Code:

NCT02249026

Conditions

Drug; Withdrawal Symptoms, Neonatal

Withdrawal

Fetus and Newborn Affected by Other Maternal Medication

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

BZDs + opiate exposure treated with BPN

Opiates exposure treated with BPN

Study Details

Brief summary:

Summary: There have been two published RCTs showing efficacy of buprenorphine treatment for NAS. However these trials excluded an estimated 22-47% of infants requiring pharmacologic treatment; those infants born to mothers with co-dependence on an opiate and a benzodiazepine. Although there are concerns, we anticipate that buprenorphine will be safe in this population. If it is safe, we can include these infants in the large double blind, double-dummy buprenorphine and clonidine vs. morphine and clonidine trial. If on the other hand, these infants have respiratory depression or other adverse events when buprenorphine is given, it will be important to report this study and caution the use of buprenorphine in these infants

Conditions

Drug; Withdrawal Symptoms, Neonatal

Withdrawal

Fetus and Newborn Affected by Other Maternal Medication

Study ID

NCT02249026

Start date

Oct, 2014

Status verified date

May, 2016

Primary completion date

Jun, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Newborns ≥ 35 0/7 wks. Gestation undelivered or < 12 hours of age at enrollment and within the 72 hrs. after birth at the time of transfer to ACH for pharmacologic treatment for moderate to severe NAS
  • Newborns ≥ 2 kg weight at birth (10th % for a 35 0/7 wk. newborn)
  • Informed parental

Exclusion Criteria:

  • Newborns <35 0/7 wks. gestation OR older than 72 hrs. of life at time of transfer to ACH for pharmacologic treatment for moderate to severe NAS
  • Major congenital anomalies
  • Major concomitant medical illness including antibiotic treatment for greater than 3 days
  • Any illness that precludes oral or sublingual medication use
  • Infants who have received any drug other than "study drug" to treat their NAS
  • Infants requiring drug therapy with any high or moderate CYP3A4 inhibitor or inducer (Appendix A)
  • Breastfeeding infants.
  • Infants in significant pain requiring medication for comfort (for example those with a fracture).

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BZDs + opiate exposure treated with BPN

In-utero opiate and BZD exposed neonates + Buprenorphine sub-lingual administered in dose volumes greater than 0.5 mL will be given in 2 aliquots separated by 2 minutes allowing time for the drug to be absorbed.

active comparator: Opiates exposure treated with BPN

In-utero opiate exposed neonates + Buprenorphine sub-lingual administered in dose volumes greater than 0.5 mL will be given in 2 aliquots separated by 2 minutes allowing time for the drug to be absorbed.

Interventions

BZDs + opiate exposure treated with BPN

These infants will have been exposed not only to opiates but also to BZDs during pregnancy. Administration of Buprenorphine: The solution will be administered under the tongue followed by the insertion of a pacifier to reduce swallowing. Dose volumes greater than 0.5 mL will be given in 2 aliquots separated by 2 minutes allowing time for the drug to be absorbed. If the infant's withdrawal is not controlled, clonidine will be used as adjunct therapy. The initial dose of clonidine is 6 mcg/kg/day in 4 divided doses given every 6 hours. If signs of withdrawal are not controlled, the dose may be increased by 3mcg/kg/day to a maximum 12 mcg/kg/day divided q 6 hrs.

Opiates exposure treated with BPN

These infants will have been exposed not only to opiates during pregnancy. Administration of Buprenorphine: The solution will be administered under the tongue followed by the insertion of a pacifier to reduce swallowing. Dose volumes greater than 0.5 mL will be given in 2 aliquots separated by 2 minutes allowing time for the drug to be absorbed. If the infant's withdrawal is not controlled, clonidine will be used as adjunct therapy. The initial dose of clonidine is 6 mcg/kg/day in 4 divided doses given every 6 hours. If signs of withdrawal are not controlled, the dose may be increased by 3mcg/kg/day to a maximum 12 mcg/kg/day divided q 6 hrs.

Primary outcome measure

  • Assessment of vital signs [ Time Frame: 2-8 weeks ]

Central Contacts and Locations

Locations

All Children's Hopsital

Recruiting

St Petersburg, Florida, United States, 33701

Contacts

Susan Bell, RN

727-767-7320susan.bell@allkids.org

Principal Investigator:

Sandra Brooks, MD

More Information

Sponsor

Gauda, Estelle B., M.D.

Last update posted

May 6, 2016

Last verified

May, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gauda, Estelle B., M.D. on 2016-05-06.