Clinical trials: Neonatal Abstinence Syndrome
Neonatal Abstinence Syndrome
Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain
The long term goals of our research are to establish the best pharmacological treatment for NAS and determine how pharmacologic treatment of NAS affects long-term developmental outcomes.
- Trial name
- No-POPPY (NCT03396588)
- Testing
- Clonidine, Morphine
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Henrietta Bada
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
Maternal Opioid Use Disorder, Opioid Exposed Infant
Maternal Buprenorphine-naloxone Treatment and the Infant
The purpose of this mechanistic study is to evaluate the effects that maternal buprenorphine-naloxone maintenance have on the neurobehavioral development of the fetus and infant.
- Trial name
- NCT03291847
- Testing
- fetal monitoring, Buprenorphine Naloxone
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Johns Hopkins University
Substance-Related Disorders, Alcohol-Related Disorders
Conflict Between Maternal Autonomy and Child Health in Substance-use
Qualitative project, comprising open-ended semi-structured interviews with healthcare workers, who provide antenatal care to substance-using women.
- Conditions
- Substance-Related Disorders, Alcohol-Related Disorders, Amphetamine-Related Disorders, Inhalant Abuse
- Trial name
- NCT02797990
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- London School of Hygiene and Tropical Medicine
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome
Infants with neonatal abstinence syndrome (NAS) experience prolonged hospital stays and poor neurodevelopmental outcomes, in-part because of the lack of accurate, individualized, biologic assessments available to manage this…
- Trial name
- NCT05937594
- Testing
- Buccal swab saliva for further genetic testing
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Milton S. Hershey Medical Center
Neonatal Abstinence Syndrome
Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome
The purpose of this study is to examine the efficacy of a specially-constructed crib mattress that delivers gentle vibrations (stochastic vibrotactile stimulation) as a complementary, non-pharmacological intervention for treating…
- Trial name
- NCT02801331
- Testing
- Stochastic Vibrotactile Stimulation (SVS)
- Where
- United States
- Volunteers
- 208 people
- Sponsor
- Elisabeth B Salisbury
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
Role of Low Lactose Infant Formula In The Management of Neonatal Abstinence Syndrome
Currently Morphine and or Methadone are the most commonly used drugs in the treatment for NAS along with supportive care. Many care providers offer tolerance "low lactose" formula to these infants to alleviate gastrointestinal…
- Trial name
- NCT03549936
- Testing
- Low lactose or regular formula
- Where
- United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- MetroHealth Medical Center
Neonatal Abstinence Syndrome
Fetal and Infant Effects of Maternal Buprenorphine Treatment
This research will track the longitudinal neurobehavioral development of the buprenorphine-exposed fetus across gestation through 1 month of age in an effort to determine the safety of this medication for use during gestation…
- Trial name
- NCT01561079
- Testing
- Buprenorphine
- Where
- 2 sites in United States
- Volunteers
- 127 people
- Sponsor
- Johns Hopkins University
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
Opioid-Related Disorders, Drug Addiction
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments 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-CMA (NCT03911466)
- Testing
- Buprenorphine Injection, Buprenorphine Sublingual Product
- Where
- 12 sites in United States
- Volunteers
- 97 people
- Sponsor
- T. John Winhusen, PhD
Opiate Dependence, Pregnancy
The Effects of Methadone and Buprenorphine on Fetal Neurobehavior and Infant Neonatal Abstinence Syndrome - 1
The purpose of this study is to evaluate the effects of drugs used by treatment providers on the fetuses and infants of opiate dependent women.
- Trial name
- NCT00218621
- Testing
- Buprenorphine / methadone
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Johns Hopkins University
Neonatal Abstinence Syndrome
A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
A randomized clinical study in NAS infants managed via the Eat, Sleep, Console (ESC) approach comparing early weight loss on a standard-caloric density versus high-caloric density feeding regimen.
- Trial name
- NCT04419857
- Testing
- High-calorie formula
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Yale University
Neonatal Abstinence Syndrome
Clinical Trial to Decrease Length of Stay in Infants With Neonatal Abstinence Syndrome With an Exclusive Human Milk Diet
A clinical trial to evaluate length of stay, growth velocity and clinical outcomes in infants with neonatal abstinence syndrome receiving an exclusive human milk diet.
- Trial name
- NCT04508348
- Testing
- Human Milk, Standard of Care
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
NAS
Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome.
- Trial name
- NCT03533985
- Testing
- Song of Kin, Gato box, Ocean disc
- Where
- 6 sites in United States
- Volunteers
- 200 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Neonatal Abstinence Syndrome
Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome
The purpose of this study is to compare clonidine versus phenobarbital as adjunctive therapy in those infants who have failed monotherapy with morphine sulfate for neonatal abstinence syndrome (NAS).
- Trial name
- NCT03670160
- Testing
- Phenobarbital, Clonidine
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Tennessee Medical Center
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
Narcotic Addiction, Neonatal Abstinence Syndrome
Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women
The Investigators hope to learn if they can prevent or lessen the symptoms of neonatal abstinence syndrome (NAS) in babies born to narcotic-dependent mothers by using the drug ondansetron in the mothers prior to delivery and…
- Trial name
- AIM2NAS (NCT01965704)
- Testing
- Ondansetron
- Where
- 8 sites in United States
- Volunteers
- 196 people
- Sponsor
- Stanford University
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
Neurostimulation to Improve NOWS Outcomes
The objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.
- Trial name
- SPROUT (NCT05129020)
- Testing
- Sparrow Fledging Therapy System
- Where
- 3 sites in United States
- Volunteers
- 52 people
- Sponsor
- Spark Biomedical, Inc.
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