Clinical trials: Opioid Withdrawal
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
Opioid Withdrawal, Physical Dependence
5HT3 Antagonists to Treat Opioid Withdrawal and to Prevent the Progression of Physical Dependence
Opioid medications are commonly used for pain relief. When given over time, physical dependence can occur. This results in unpleasant side effects (such as agitation and nausea) if opioid medications are suddenly stopped.
- Trial name
- NCT01549652
- Testing
- Ondansetron, Morphine, Naloxone 0.4 mg/70 kg
- Where
- United States
- Volunteers
- 133 people
- Sponsor
- Stanford University
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
Chronic Lower Back Pain, Chronic Pain
Buprenorphine (CAM2038) in Subjects With a Recent History of Moderate to Severe Chronic Low Back Pain
This is a Phase III, placebo-controlled, multicenter study with an enriched-enrollment withdrawal (EEW) design to evaluate the efficacy and safety of CAM2038 in opioid-experienced subjects with moderate to severe CLBP that…
- Trial name
- CAM2038 (NCT02946073)
- Testing
- buprenorphine
- Where
- 69 sites in United States
- Volunteers
- 1,053 people
- Sponsor
- Braeburn Pharmaceuticals
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
Opioid-Related Disorders
Phase IIa Study of AV411, a Glial Activation Inhibitor, for Opioid Withdrawal
Repeated use and/or abuse of opioid medications is generally associated with a characteristic withdrawal syndrome that develops after cessation of drug administration.
- Trial name
- AV411 (NCT00723177)
- Testing
- AV411
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
Opioid-Related Disorders, Opioid Dependence
An Innovative Intervention for OUD Treatment
The Bridge Device (BD) is a neuromodulator medical device that has been cleared by the FDA for Opioid Use Disorder (OUD) treatment.
- Conditions
- Opioid-Related Disorders, Opioid Dependence, Opioid Addiction, Opioid Withdrawal
- Trial name
- Bridge (NCT04325659)
- Testing
- Bridge Device, Lofexidine
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
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-use Disorder
Surmounting Withdrawal to Initiate Fast Treatment With Naltrexone
This study compares two methods of initiating treatment with extended-release naltrexone (XR-NTX) when implemented at community-based inpatient or residential programs.
- Trial name
- SWIFT (NCT04762537)
- Testing
- Standard Induction Procedure (SP), Rapid Induction Procedure (RP)
- Where
- 6 sites in United States
- Volunteers
- 415 people
- Sponsor
- New York State Psychiatric Institute
Neonatal Opiate Withdrawal Syndrome
Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach
This clinical trial will help us learn more about how to best care for babies with Neonatal Opioid Withdrawal Syndrome, also called NOWS.
- Trial name
- OPTimize NOW (NCT05980260)
- Testing
- Symptom-based Dosing Approach, Scheduled Opioid Taper Approach
- Where
- 23 sites in United States
- Volunteers
- 626 people
- Sponsor
- HELP for NOWS Consortium
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
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)
Opioid Use Disorder
NET Device for Treating Opioid Use Disorder
This prospective, randomized, double-blind, parallel-group, sham-controlled, superiority study will evaluate the effectiveness of the NET Device in treating persons with Opioid Use Disorder (OUD) without use of Medications for…
- Trial name
- NCT04916600
- Testing
- NET
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- Wayne State University
Tobacco Use Disorder
Low Nicotine Content Cigarettes in Vulnerable Populations: Opioid Use Disorder
Prevalence of smoking among individuals with opioid use disorder (OUD) is six-fold that of the general US adult population. The mortality rate of opioid-dependent smokers is four times that of opioid-dependent nonsmokers, and…
- Trial name
- NCT04092101
- Testing
- Cigarettes with varying nicotine content, E-Cigarettes
- Where
- 2 sites in United States
- Volunteers
- 326 people, healthy volunteers welcome
- Sponsor
- University of Vermont
Tumor, Pain
A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine
The purpose of this study will be to determine whether tapentadol (CG5503) is effective and safe in the treatment of chronic tumor related pain compared to placebo.
- Trial name
- NCT00472303
- Testing
- Tapentadol Extended Release, Morphine Sulphate Controlled Release
- Where
- 71 sites in Austria, Bulgaria and 14 more
- Volunteers
- 622 people
- Sponsor
- Grünenthal GmbH
Iatrogenic Withdrawal Syndrome
Jackson Pediatric Acupressure for Opioid Tapering
This intervention pilot feasibility study will assess the impact of auricular acupressure as an additional non-pharmacologic therapy for infants at risk for developing Iatrogenic Withdrawal Syndrome (IWS) in the Pediatric Cardiac…
- Trial name
- NCT05025384
- Testing
- Acupressure
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Vanderbilt University Medical Center
Cocaine Dependence, Opiate Dependence
Cocaine Withdrawal and Pharmacotherapy Response
A total of 120 male and female opioid dependent cocaine users will participate in this study. This study will be a 8-week double-blind, placebo controlled study examining the dose-dependent effects of carvedilol (up to 50 mg/day)…
- Trial name
- Carvedilol (NCT00566969)
- Testing
- sugar pill, Carvedilol 25 mg, Carvedilol 50 mg
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Yale University
Opioid Withdrawal
Lofexidine for Adults Undergoing Lumbar Spine Surgery
The primary objective is to investigate the effects of lofexidine in adults undergoing opioid tapering prior to elective lumbar spine surgery.
- Trial name
- NCT04126083
- Testing
- Lofexidine Oral Tablet
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Mayo Clinic
Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal
Improving Outcomes in Neonatal Abstinence Syndrome
1: SPECIFIC Aim I: To compare treatment options for neonatal abstinence syndrome (NAS) due to in-utero narcotic exposure. One hundred eighty four full-term infants with a diagnosis of NAS requiring medications will be studied.
- Trial name
- NCT01958476
- Testing
- Neonatal Morphine Solution, Methadone, Phenobarbital
- Where
- 8 sites in United States
- Volunteers
- 117 people
- Sponsor
- Tufts Medical Center
Opioid Dependence, Opioid Withdrawal
Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals
This study involves inducting treatment seeking opioid dependent participants onto buprenorphine. Once the participant reaches a stable dose they will receive either placebo or gabapentin to determine if gabapentin helps ease…
- Conditions
- Opioid Dependence, Opioid Withdrawal, Opioid Detoxification
- Trial name
- Detox (NCT01262092)
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Arkansas