Buprenorphine for the Treatment of Neonatal Abstinence Syndrome
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ClinicalTrials.gov Identifier: NCT00521248 |
Recruitment Status :
Completed
First Posted : August 27, 2007
Last Update Posted : January 12, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neonatal Abstinence Syndrome | Drug: buprenorphine Drug: Oral morphine solution | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Buprenorphine for the Treatment of Neonatal Abstinence Syndrome |
Study Start Date : | April 2004 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | January 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Oral morphine solution
Oral morphine solution
|
Drug: Oral morphine solution
0.4 mg/kg/day morphine every 4 hours
Other Name: morphine |
Experimental: Buprenorphine
Sublingual buprenorphine
|
Drug: buprenorphine
sublingual buprenorphine administered every 8 hours, titrated to control of abstinence symptoms
Other Name: Buprenex (buprenorphine) |
- Sublingual Buprenorphine safety and tolerability in the neonate [ Time Frame: Index hospitalization ]
- Buprenorphine Pharmacokinetics [ Time Frame: Index hospitalization ]
- Efficacy: Length of treatment [ Time Frame: Index hospitalization ]
- Efficacy: Length of hospitalization [ Time Frame: Index hospitalization ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ≥ 37 weeks gestation
- exposure to opiates in utero
- demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment
Exclusion Criteria:
- major congenital malformations and/or intrauterine growth retardation
- medical illness requiring intensification of medical therapy
- concomitant benzodiazepine or severe alcohol abuse, self-report of regular use of alcohol or of benzodiazepines use in the past 30 days, and/or receipt of benzodiazepines by prescription (as determined by self-report or intake urine) by the mother during pregnancy,
- concomitant use of CYP 3A inhibitors (erythromycin, clarithromycin, ketoconazole, itraconazole, HIV protease inhibitors) or inducers (rifampin, carbamazepine, phenobarbital) prior to initiation of NAS treatment
- seizure activity or other neurologic abnormality
- breast feeding
- inability of mother to give informed consent due to co-morbid psychiatric diagnosis
- hypoglycemia requiring treatment with intravenous glucose

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521248
United States, Pennsylvania | |
Thomas Jefferson University Hospital | |
Philadelphia, Pennsylvania, United States, 19107 |
Principal Investigator: | Walter K Kraft, MD, MS | Thomas Jefferson University |
Responsible Party: | Steve Oversby, NIDA |
ClinicalTrials.gov Identifier: | NCT00521248 |
Other Study ID Numbers: |
R21DA018207-01 ( U.S. NIH Grant/Contract ) R21DA018207-01 ( U.S. NIH Grant/Contract ) DPMC ( Other Identifier: NIDA ) |
First Posted: | August 27, 2007 Key Record Dates |
Last Update Posted: | January 12, 2017 |
Last Verified: | December 2009 |
Neonatal Abstinence Syndrome buprenorphine neonatal opioid withdrawal |
Neonatal Abstinence Syndrome Syndrome Disease Pathologic Processes Infant, Newborn, Diseases Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Morphine |
Buprenorphine Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |