Clinical trials: Opioid Withdrawal
Opioid Use Disorder, Maternal Drugs Affecting Fetus
Night Respite for Postpartum Mothers With SUD
This single arm pilot feasibility study will evaluate the implementation of overnight infant respite care and parenting skills to mothers with substance use disorders in the early postpartum period residing in residential…
- Conditions
- Opioid Use Disorder, Maternal Drugs Affecting Fetus, Postpartum Mood Disturbance, Sleep Disorder
- Trial name
- NCT05746507
- Testing
- Night Respite Care
- Where
- 2 sites in United States
- Volunteers
- 41 people
- Sponsor
- Massachusetts General Hospital
Opioid Withdrawal
Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal
This Phase 1b/2 inpatient study assessed the safety, pharmacokinetics, and early signs of efficacy of escalating doses of BXCL501 versus placebo following discontinuation of morphine maintenance.
- Trial name
- NCT04470050
- Testing
- Dexmedetomidine
- Where
- 3 sites in United States
- Volunteers
- 225 people
- Sponsor
- BioXcel Therapeutics Inc
Neonatal Opioid Withdrawal Syndrome
Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)
The objective of this study is to evaluate the efficacy of a rapid wean intervention compared with a slow-wean intervention in reducing the number of days of opioid treatment from the first dose of weaning to cessation of opioid…
- Trial name
- NCT04214834
- Testing
- Morphine, Methadone
- Where
- 24 sites in United States
- Volunteers
- 189 people
- Sponsor
- Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
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
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
Opioid Use, Unspecified With Withdrawal, Opioid-Induced Disorders
Adjunct Methadone to Decrease the Duration of Mechanical Ventilation in the Medical Intensive Care Unit
The purpose of this study is to determine if administering methadone to mechanically ventilated patients in the medical intensive care unit (ICU) requiring continuous infusions of sedatives and analgesics will decrease the time…
- Conditions
- Opioid Use, Unspecified With Withdrawal, Opioid-Induced Disorders, Delirium
- Trial name
- NCT02025855
- Testing
- Methadone
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Henry Ford Health System
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 Withdrawal (Disorder)
Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal
Stopping prescription opioid pain medications can be difficult due to withdrawal symptoms. This study will test if LUCEMYRA helps reduce withdrawal symptoms and helps more people reduce their opioid dose compared to placebo.
- Trial name
- TAPER (NCT04070157)
- Testing
- Lofexidine
- Where
- 12 sites in United States
- Volunteers
- 4 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Opioid Withdrawal
Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal
A phase II double-blind placebo-controlled parallel group clinical trial that will randomize 90 subjects to investigate whether pregabalin (PGB) combined with Lofexidine (LFX) can reduce opioid withdrawal-related subjective…
- Trial name
- PGB-LOF (NCT04218240)
- Testing
- Pregabalin 200 MG capsules, Lofexidine 0.18Mg Tab
- Where
- 3 sites in United States
- Volunteers
- 90 people
- Sponsor
- University of Pennsylvania
Substance-Related Disorders, Substance Use Disorders
Non-Invasive Vagal Nerve Stimulation in Opioid Use Disorders
Subjects in this study will be patients with opioid use disorders (OUDs) based on DSM-5 criteria recruited from the greater Atlanta metropolitan region.
- Conditions
- Substance-Related Disorders, Substance Use Disorders, Substance Abuse, Intravenous, Substance Withdrawal
- Trial name
- nVNS in OUDs (NCT04556552)
- Testing
- Non invasive VN stimulation (nVNS), Oxygen (15-O) Water
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Emory University
Opioid Withdrawal, Opioid Craving
Oral Cannabidiol for Opioid Withdrawal
This pilot study will examine the safety of the cannabinoid cannabidiol (Epidiolex) in a human laboratory model of clinically relevant withdrawal.
- Conditions
- Opioid Withdrawal, Opioid Craving, Opioid Use Disorder
- Trial name
- NCT04238754
- Testing
- Epidiolex
- Where
- United States
- Volunteers
- 3 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.
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 Dependence, Opioid Withdrawal
Medical Management of Sleep Disturbance During Opioid Tapering
This study will evaluate whether a dual orexin-receptor antagonist approved by the FDA for sleep disturbance, suvorexant (SUVO; Belsomra), will increase total sleep time in patients with opioid use disorder (OUD) undergoing…
- Conditions
- Opioid Dependence, Opioid Withdrawal, Sleep Disturbance
- Trial name
- NCT03789214
- Testing
- Low Dose Suvorexant, High Dose Suvorexant
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Johns Hopkins University
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 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)
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
Oxytocin Treatment of Opioid Dependence
Purpose: The purpose of this research study is to learn whether oxytocin treatment decreases use of and cravings for opioids (narcotics) in people who have been using opioids heavily for long periods of time and are unable to…
- Trial name
- NCT02548728
- Testing
- Intranasal Oxytocin Spray
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of North Carolina, Chapel Hill
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