Clinical trials: Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome
Use of SVS Device to Improve Outcomes for Neonatal Opioid Withdrawal Syndrome.
Maternal use and addiction to opioids has resulted in an unprecedented rise in drug withdrawal complications in newborns known as neonatal opioid withdrawal syndrome (NOWS), also referred to as neonatal abstinence syndrome (NAS).
- Trial name
- NCT04834297
- Testing
- Prapela SVS mattress
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Tufts Medical Center
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
Nurse's Role, Stigma, Social
Testing an Arts-based Program to Reduce Nurse Stigma Towards Perinatal Substance Use
The goal of this pilot clinical trial is to evaluate the feasibility and limited effectiveness of a digital, arts-based educational intervention addressing nurse stigma towards perinatal substance use.
- Conditions
- Nurse's Role, Stigma, Social, Implicit Bias
- Trial name
- NCT06410287
- Testing
- ArtSpective
- Where
- 2 sites in United States
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Opioid Withdrawal
Open-Label, Safety Study of Lofexidine
The purpose of this Phase 3 open-label treatment study is to evaluate the safety and effectiveness of lofexidine at a clinically relevant dose to alleviate symptoms of acute withdrawal from any opioid, including methadone and…
- Trial name
- NU LEAF (NCT02363998)
- Testing
- Lofexidine
- Where
- 18 sites in United States
- Volunteers
- 286 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Neonatal Abstinence Syndrome
Donor Human Milk in Neonatal Abstinence Syndrome
This study is designed to develop pilot data on the acceptability and benefit of donor human milk for infants undergoing pharmacologic treatment for NAS.
- Trial name
- DHM&NAS (NCT02182973)
- Testing
- donor human milk
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neolac Inc dba Medolac Laboratories
Alcohol Withdrawal Syndrome
Gabapentin for Alcohol Withdrawal Syndrome
The current "gold-standard" for the management of alcohol withdrawal syndrome (AWS) is symptom-triggered administration of benzodiazepines.
- Trial name
- NCT03012815
- Testing
- Gabapentin, Benzodiazepines, Divalproex Sodium
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- Mayo Clinic
Neonatal Opioid Withdrawal Syndrome
CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
A Phase II, multicenter, double blind, double dummy, randomized, 2 arms parallel study to evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with Neonatal Opioid Withdrawal Syndrome
- Trial name
- NOWSHINE (NCT04104646)
- Testing
- CHF6563, Morphine
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Opioid-Related Disorders, Drug Addiction
Medication Treatment for Opioid Use Disorder in Expectant Mothers
The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and…
- Conditions
- Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse
- Trial name
- MOMs (NCT03918850)
- Testing
- Buprenorphine Injection, Buprenorphine Sublingual Product
- Where
- 12 sites in United States
- Volunteers
- 140 people
- Sponsor
- T. John Winhusen, PhD
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
Pain
Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film
The primary aim of this study is to determine if chronic pain subjects on around-the-clock opioids who are receiving 100 to 220 mg oral morphine sulfate equivalent (MSE) can be safely transitioned on to buprenorphine…
- Trial name
- NCT01871285
- Testing
- Buprenorphine, Oxycodone, Morphine sulfate
- Where
- 3 sites in United States
- Volunteers
- 39 people
- Sponsor
- BioDelivery Sciences International
Opioid Dependence, Acute Opioid Withdrawal Syndrome
Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal
The purpose of this study is to look at the efficacy and safety for lofexidine hydrochloride, an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids.
- Trial name
- NCT01863186
- Testing
- Lofexidine HCl, Open Label Lofexidine HCL
- Where
- 18 sites in United States
- Volunteers
- 603 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Sleep Disorder, Restless Legs Syndrome
Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD
The investigators propose to test the use of pramipexole in patients being treated for Opioid Use Disorder to test its ability to reduce symptoms of both Restless Legs Syndrome and protracted opioid withdrawal and thereby promote…
- Conditions
- Sleep Disorder, Restless Legs Syndrome, Opioid-use Disorder, Opioid Withdrawal
- Trial name
- NCT04759703
- Testing
- Pramipexole
- Where
- 2 sites in United States
- Volunteers
- 75 people
- Sponsor
- Massachusetts General Hospital
Alcohol Withdrawal Delirium
Treating Alcohol Withdrawal With Oral Baclofen
The purpose of this study is determine if subjects with alcohol withdrawal who receive oral baclofen, plus standard benzodiazepine therapy, will experience less severe withdrawal symptoms than those who receive placebo plus…
- Trial name
- NCT00597701
- Testing
- Baclofen, Lorazepam
- Where
- United States
- Volunteers
- 79 people
- Sponsor
- Essentia Health
Autistic Disorder, Autism
Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine
The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder…
- Conditions
- Autistic Disorder, Autism, Asperger's Disorder, Asperger Syndrome
- Trial name
- NCT01592747
- Testing
- Memantine Hydrochloride (HCl)
- Where
- 94 sites in United States, Belgium and 13 more
- Volunteers
- 479 people
- Sponsor
- Forest Laboratories
Acute Leukemia, Acute Myeloid Leukemia
A Study of Withdrawal of Immunosuppression and Donor Lymphocyte Infusions Following Allogeneic Transplant for Pediatric Hematologic Malignancies
There is no curative therapy once acute leukemia patients relapse after transplant. Patients who develop clinically significant graft versus host disease (GVHD) have a lower rate of relapse than those who do not develop GVHD.
- Conditions
- Acute Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Biphenotypic Leukemia
- Trial name
- NCT01036009
- Testing
- Withdrawal of immunosuppression and donor lymphocyte infusion
- Where
- 2 sites in United States
- Volunteers
- 43 people
- Sponsor
- University of California, San Francisco
Obstructive Sleep Apnea
"Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
- Trial name
- OSA (NCT02348619)
- Testing
- JZP-110
- Where
- 30 sites in United States, Finland and 3 more
- Volunteers
- 174 people
- Sponsor
- Jazz Pharmaceuticals
Tourette Disorder
Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults
This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of Tourette's Disorder (TD).
- Trial name
- D1AMOND (NCT05615220)
- Testing
- Ecopipam Hydrochloride
- Where
- 95 sites in United States, Bulgaria and 10 more
- Volunteers
- 216 people
- Sponsor
- Emalex Biosciences Inc.
Endogenous Cushing's Syndrome
A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.
This is a double-blind, randomized, placebo-controlled withdrawal and rescue/restoration study in subjects with endogenous Cushing's Syndrome (CS) previously treated with single-arm, open-label levoketoconazole that will assess…
- Trial name
- NCT03277690
- Testing
- Levoketoconazole
- Where
- 45 sites in United States, Bulgaria and 10 more
- Volunteers
- 84 people
- Sponsor
- Cortendo AB
Liver Transplant
Liver Transplantation With Tregs at UCSF
This is a single-center, prospective, open-label, non-randomized clinical trial exploring cellular therapy to facilitate immunosuppression withdrawal in liver transplant recipients.
- Trial name
- LITTMUS-UCSF (NCT03654040)
- Testing
- arTreg, leukapheresis, cyclophosphamide
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Alcohol Withdrawal Delirium, Alcohol Withdrawal Associated Autonomic Hyperactivity
Dexmedetomidine (Precedex®) for Severe Alcohol Withdrawal Syndrome (AWS) and Alcohol Withdrawal Delirium (AWD)
This is a prospective, randomized, double-blind, placebo-controlled, parallel-group study of dexmedetomidine versus placebo, with lorazepam rescue, for the management of severe alcohol withdrawal syndrome (AWS) and alcohol…
- Conditions
- Alcohol Withdrawal Delirium, Alcohol Withdrawal Associated Autonomic Hyperactivity, Alcohol Withdrawal Hallucinosis, Alcohol Withdrawal-Induced Delirium Tremens
- Trial name
- NCT01362205
- Testing
- Dexmedetomidine
- Where
- 7 sites in United States
- Volunteers
- 49 people
- Sponsor
- Denver Health and Hospital Authority