Clinical trials: Substance Withdrawal Syndrome
Neonatal Abstinence Syndrome
Physiology and Therapeutic Management of Neonatal Abstinence Syndrome
The overall purpose of this project is to to quantify the physiology of neonatal drug withdrawal and develop non-pharmacological techniques to help improve the therapeutic management of Neonatal Abstinence Syndrome (NAS).
- Trial name
- NCT02768844
- Testing
- Stochastic Vibrotactile Stimulation (SVS), Control
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- University of Massachusetts, Worcester
Heroin Dependence, Morphine Dependence
Buprenorphine/Naloxone Versus Clonidine for Outpatient Opiate Detoxification - 1
The purpose of this study is to assess buprenorphine/naloxone versus clonidine for outpatient opiate detoxification.
- Conditions
- Heroin Dependence, Morphine Dependence, Substance Withdrawal Syndrome
- Trial name
- NCT00032968
- Testing
- Buprenorphine/naloxone
- Where
- 7 sites in United States
- Volunteers
- 341 people
- Sponsor
- University of California, Los Angeles
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 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
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
Opioid Withdrawal (Disorder), Opioid Use Disorder
A Pharmacokinetic, Safety, and Tolerability Study of LUCEMYRA in the Treatment of Opioid Withdrawal Management in Adolescent Subjects
The goal of this clinical study is to evaluate the pharmacokinetic (PK), safety, and tolerability of LUCEMYRA in adolescents age ≥12 to <18 years old abruptly discontinuing opioid use.
- Trial name
- NCT06711640
- Testing
- LUCEMYRA (lofexidine) tablets
- Where
- United States
- Sponsor
- USWM, LLC (dba US WorldMeds)
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.
Heroin Dependence, Morphine Dependence
Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate Detoxification - 1
The purpose of this study is to assess buprenorphine/naloxone versus clonidine for inpatient opiate detoxification.
- Conditions
- Heroin Dependence, Morphine Dependence, Substance Withdrawal Syndrome
- Trial name
- NCT00032955
- Testing
- Buprenorphine/naloxone
- Where
- 6 sites in United States
- Volunteers
- 163 people
- Sponsor
- University of California, Los Angeles
Withdrawal Syndrome
Protocolized Sedative Weaning VS. Usual Care in Pediatric Critically Ill, RCT
Sedative and analgesic agents are widely used in the ICU. These agents can provide hypnotic effect, pain alleviation, cooperation, and synchronizing ventilatory support.
- Trial name
- NCT03018977
- Testing
- The sedative weaning protocol group, The usual group
- Where
- Thailand
- Volunteers
- 60 people
- Sponsor
- Ramathibodi Hospital
Substance Withdrawal Syndrome, Critical Illness
Opioid Withdrawal Symptoms in Critically Ill Patients
Most critically ill patients encounter pain and distress from acute illness, medical procedures and devices as well as routine care in the intensive care units (ICU).
- Trial name
- NCT03374722
- Testing
- Opioids
- Where
- Thailand
- Volunteers
- 55 people
- Sponsor
- Mahidol University
Neonatal Abstinence Syndrome
tAN to Mitigate Withdrawal Behaviors in Neonates
This first in-human-neonates, open-label pilot trial is designed to determine whether use of tAN in newborns with NOWS receiving oral morphine allows for faster weaning of morphine and decrease morphine use altogether.
- Trial name
- NCT04588519
- Testing
- Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Spark Biomedical, Inc.
Withdrawal Symptoms
The Potentially Addictive Properties of Soda: A Feasibility Study
The purpose of this study to investigate the addictive properties of soda and other sugar sweetened beverages (SBBs) in teenagers aged 13-18 years.
- Trial name
- NCT02044757
- Testing
- SSB withdrawal
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University of California, Berkeley
Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome
Cerebral Physiology of NOWS
This study will use a new device to measure blood flow and oxygen levels in the brains of newborn infants who have had exposure to opioid medications in the womb, compared to newborns who have not had any exposure.
- Conditions
- Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome, Opioid Use Disorder, Intrauterine Exposure
- Trial name
- NIRS for NOWS (NCT07610746)
- Testing
- FD-NIRS and DCS
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Indiana University
Neonatal Opioid Withdrawal Syndrome
Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome
The goal of this observational study is to learn how two medicines used in routine care-buprenorphine and morphine-affect recovery in newborns (≥36 weeks' gestation) with Neonatal Opioid Withdrawal Syndrome (NOWS).
- Trial name
- TreaT NOW (NCT07278375)
- Where
- 22 sites in United States
- Volunteers
- 796 people
- Sponsor
- HELP for NOWS Consortium
Neonatal Abstinence Syndrome
Buprenorphine for the Treatment of Neonatal Abstinence Syndrome
Neonatal abstinence syndrome is a disease that affects children who were exposed to opioid drugs prior to birth. Commonly used treatments at present include morphine or tincture of opium.
- Trial name
- NCT00521248
- Testing
- buprenorphine, Oral morphine solution
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Thomas Jefferson University
Neonatal Abstinence Syndrome
NAS Treatment - Opiate Versus Non-Opiate
The purpose of this study is to compare two different medicines to treat babies with opiate withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a non-opiate.
- Trial name
- NAS (NCT01734551)
- Testing
- Morphine, Clonidine
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Henrietta Bada
Neonatal Opioid Withdrawal Syndrome
ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study
The objective of this longitudinal cohort study is to quantify the effects of antenatal opioid exposure on the trajectory of brain development over the first 2 years of life, examine associations with developmental and…
- Trial name
- OBOE (NCT04149509)
- Where
- 6 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Delirium, Withdrawal Syndrome
Early Rehabilitation in Critically Ill Children - The PICU Liber8 Study
This is a pilot quality improvement implementation study that will measure the impact of a rehabilitation bundle implementation on the outcomes of interest.
- Conditions
- Delirium, Withdrawal Syndrome, Hospital Acquired Condition, Critical Illness Myopathy
- Trial name
- PICULiber8 (NCT03573479)
- Testing
- PICU Liber8 Bundle
- Where
- 2 sites in Canada
- Volunteers
- 130 people
- Sponsor
- McMaster University
Neonatal Abstinence Syndrome
Clonidine to Treat Iatrogenic-induced Opioid Dependence in Infants
Thousands of critically ill infants (and children) are exposed to opioids and benzodiazepines to achieve sedation and analgesia as part of routine care in neonatal and pediatric intensive care units.
- Trial name
- NCT01360450
- Testing
- Clonidine HCL, saline
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Johns Hopkins University
Dexmedetomidine, Midazolam
Prospective, Randomized, Open Label Controlled Trial To Evaluate The Safety And Efficacy Of Dexmedetomidine Use Beyond 24 Hours Compared With Midazolam In Children Admitted To Pediatric Intensive Care Unit at King Abdullah Specialist Children Hospital- Ministry of National Guard Health Affairs.
Study will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia.
- Conditions
- Dexmedetomidine, Midazolam, Withdrawal Symptoms, Failure of Extubation
- Trial name
- PROMISE (NCT05485519)
- Testing
- Dexmedetomidine, Midazolam
- Where
- Saudi Arabia
- Volunteers
- 430 people
- Sponsor
- King Abdullah International Medical Research Center