Clinical trials: Neonatal Abstinence Syndrome
Opioid-use Disorder, Contraception
Averting NAS Among Opioid-Using Young Women Receiving MAT Using Buprenorphine
The primary objective of this study is to test the efficacy of a Motivational Interviewing and Educational Training intervention with immediate linkage to long acting reversible contraception (LARC) (hereafter known as MIET).
- Conditions
- Opioid-use Disorder, Contraception, Neonatal Abstinence Syndrome
- Trial name
- NAS-MIET (NCT04611659)
- Testing
- Motivational Interviewing and Educational Training (MIET)
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Meharry Medical College
Neonatal Abstinence Syndrome, Neonatal Opiate Withdrawal Syndrome
Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure
Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine.
- Trial name
- B-PHORE (NCT03608696)
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Thomas Jefferson University
Neonatal Abstinence Syndrome, Neonatal Withdrawal Syndrome
Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS)
The purpose of the study is to determine whether buprenorphine is a beneficial, safe, cost effective treatment alternative to morphine sulfate in the treatment of Neonatal Abstinence Syndrome (NAS).
- Trial name
- NCT01708707
- Testing
- Buprenorphine, Morphine Sulfate
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Pediatrix
Substance Addiction
Maternal Acupuncture for Substance Abuse
To determine the efficacy of daily maternal acupuncture treatments in reducing the frequency and severity of neonatal abstinence syndrome among infants born to substance-using women..
- Trial name
- NCT00225316
- Testing
- Acupuncture
- Where
- Canada
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Neonatal Abstinence Syndrome
Efficacy of Auricular Acupuncture on Neonatal Abstinence Syndrome
This study will assess the efficacy of needle auricular acupuncture (AA) in neonatal abstinence syndrome (NAS) infants who require pharmacologic therapy at the Tampa General Hospital NICU.
- Trial name
- AA NAS (NCT02872077)
- Testing
- Auricular acupuncture
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of South Florida
Neonatal Abstinence Syndrome
Comparison Between Methadone and Morphine for Neonatal Opiate Withdrawal
Hypothesis is that the effectiveness of opiate treatment with morphine will result in shorter duration of opiate medication treatment and fewer infants treated with a second drug.
- Trial name
- NAS (NCT01804075)
- Testing
- Methadone, Morphine
- Volunteers
- 31 people
- Sponsor
- Eastern Maine Medical Center
Hypoxic-Ischemic Encephalopathy, Hypoglycemia
Quantitative Assessment of Sucking for Early Diagnosis of Brain Injury in Infants at High Risk
The main goal of this study is to quantitatively assess the sucking and feeding activity of infants at high risk of neurological impairment (preterm infants and term infants at risk of abnormal neurodevelopment) during oral…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Hypoglycemia, Neonatal Abstinence Syndrome
- Trial name
- NCT03246243
- Testing
- nfant feeding solution
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Neonatal Abstinence Syndrome, Withdrawal
Feasibility of Auricular Acupressure as an Adjunct Treatment for Neonatal Abstinence Syndrome (NAS)
This study will assess the feasibility of implementing auricular acupressure as an additional non-pharmacologic therapy for neonates at risk for developing neonatal abstinence syndrome (NAS) at Monroe Carrell Jr Children's…
- Trial name
- NCT03973801
- Testing
- Auricular acupuncture
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Vanderbilt University Medical Center
Neonatal Opioid Withdrawal Syndrome
Randomized Control Trial of Buprenorphine vs. Morphine for the Treatment of Neonatal Opioid Withdrawal Syndrome (NOWS)
This randomized control trial will compare buprenorphine and morphine, two currently used medications for the treatment of neonatal opioid withdrawal syndrome (NOWS), in newborns to determine which medication will reduce the…
- Trial name
- NCT04455802
- Where
- United States
- Sponsor
- Women and Infants Hospital of Rhode Island
Infant Apnea, Neonatal Abstinence Syndrome
Interventions to Help Infants Recover in the Hospital
This pilot project will evaluate independently two non-pharmacological interventions, 1) Neurosensory, Environmental Adaptive Technology (NEATCAP) and 2) Stochastic Vibrotactile Stimulation (SVS), as adjuvant non-pharmacological…
- Conditions
- Infant Apnea, Neonatal Abstinence Syndrome, Sleep
- Trial name
- NCT03881553
- Testing
- NEATCAP, SVS mattress
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Elisabeth Salisbury, PhD
Drug Addiction
Recovery Housing For Drug Dependent Pregnant Women
For the past several years our research program has developed and tested an intensive outpatient intervention that is based in social learning theory and employs abstinence contingent access to recovery housing as a routine…
- Trial name
- HOME (NCT00497302)
- Testing
- RBT, usual care
- Where
- United States
- Volunteers
- 128 people
- Sponsor
- Johns Hopkins University
Neonatal Abstinence Syndrome
RCT of High- vs. Standard-Calorie Formula for Methadone-Exposed Infants
Neonatal abstinence syndrome (NAS) symptoms contribute to poor infant weight gain. Early caloric enhancement for infants exposed to methadone is inexpensive, readily available, easy to implement and could improve early outcomes…
- Trial name
- NCT02178189
- Testing
- High Calorie Infant formula, Standard Calorie Infant Formula
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- University of Pittsburgh
Opioid-Related Disorders, Drug Addiction
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1).
- Conditions
- Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse
- Trial name
- MOMs-INO (NCT03911739)
- Testing
- Buprenorphine Injection, Buprenorphine Sublingual Product
- Where
- 10 sites in United States
- Volunteers
- 71 people
- Sponsor
- T. John Winhusen, PhD
Neonatal Abstinence Syndrome
Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines
The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS.
- Trial name
- MOPPlus (NCT01671410)
- Testing
- oral morphine, sublingual buprenorphine
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Thomas Jefferson University
Opioid-use Disorder, Opioid Withdrawal
Maternal Opioid Treatment: Human Experimental Research - Data Yield Appropriate Decisions
This study will compare medically-supervised withdrawal (MSW, 'detoxification') to opioid agonist treatment (OAT, 'maintenance') with buprenorphine for pregnant women with opioid use disorder in terms of maternal, fetal, and…
- Conditions
- Opioid-use Disorder, Opioid Withdrawal, Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal Syndrome
- Trial name
- MOTHER DYAD (NCT04049799)
- Testing
- Medically-supervised withdrawal, Opioid agonist treatment, Comprehensive clinical care
- Where
- 4 sites in United States
- Volunteers
- 88 people
- Sponsor
- University of Vermont
Neonatal Abstinence Syndrome
Assessing the Effects of Auricular Acupressure on Newborns With NAS
This study will determine the feasibility of using auricular acupressure as an intervention in newborns with neonatal abstinence syndrome(NAS).
- Trial name
- NCT03890562
- Testing
- Auricular acupressure
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Virginia Commonwealth University
Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal
Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
Randomized pilot trial comparing scheduled morphine dosing with a weaning protocol to intermittent morphine dosing on an as-needed basis for newborns with neonatal abstinence syndrome.
- Conditions
- Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome
- Trial name
- NCT04298853
- Testing
- Morphine PRN, Morphine scheduled
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Indiana University
Neonatal Abstinence Syndrome
Actigraphy and Neonatal Abstinence Syndrome
The aim of our study is to analyse the correlation between actigraphy and Lipsitz scoring system in neonatal opioid abstinence syndrome.
- Trial name
- ACTINEO (NCT03977545)
- Testing
- Actigraphy
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University Hospital, Caen
Neonatal Abstinence Syndrome
Treatment of Neonatal Abstinence Syndrome
This study compares treatment of Neonatal Abstinence Syndrome (NAS) with two different drugs for the difference in the length of treatment.
- Trial name
- HOMENOW (NCT01723722)
- Testing
- Methadone, Diluted Deodorized Tincture of Opium
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Eastern Maine Medical Center
Neonatal Abstinence Syndrome
Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome
This is a prospective randomized double blinded study comparing the effect on duration of pharmacologic treatment and duration of hospital stay when using clonidine at 12 µg/kilogram/day as an adjunct to oral morphine as compared…
- Trial name
- NCT03762317
- Testing
- Clonidine
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Hennepin County Medical Center, Minneapolis