Clinical trials: Substance Withdrawal Syndrome
Neonatal Opiate Withdrawal Syndrome
Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
The overall objective is to determine if the ESC care approach will reduce the time until infants being managed for NOWS are medically ready for discharge.
- Trial name
- (ESC-NOW) (NCT04057820)
- Testing
- Finnegan Neonatal Abstinence Scoring Tool, Eat, Sleep, Console (ESC) care tool
- Where
- 26 sites in United States
- Volunteers
- 1,305 people
- Sponsor
- Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
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)
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
Substance Withdrawal Syndrome
Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal
Prescription opioid addiction is a growing public health problem and more pharmacologic treatments are needed because current approved medications have had limited patient acceptance (naltrexone), limited availability…
- Trial name
- NCT00980044
- Testing
- Tramadol
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Michelle Lofwall
Alcohol Withdrawal Syndrome
Preventing Alcohol Withdrawal Syndrome With Oral Baclofen
Adult medical/surgical inpatient hospital care is more difficult and more expensive when complicated by alcohol dependency (AD), especially for patients who develop alcohol withdrawal syndrome (AWS).
- Trial name
- NCT02052440
- Testing
- Baclofen
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Denver Health and Hospital Authority
Substance Withdrawal Syndrome
Signs and Symptoms of Opioid-associated Iatrogenic Withdrawal in Critically Ill Adults
Mechanically ventilated critically ill adults may require prolonged administration of opioids to facilitate ventilator support and maintain comfort.
- Trial name
- SOWA-ICU (NCT03435614)
- Testing
- Opioids
- Where
- Canada
- Volunteers
- 29 people
- Sponsor
- Marc M. Perreault
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
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
Neonatal Abstinence Syndrome
Comparison Between Methadone and Morphine for Neonatal Opiate Withdrawal
Hypothesis is that the effectiveness of opiate treatment with morphine will result in shorter duration of opiate medication treatment and fewer infants treated with a second drug.
- Trial name
- NAS (NCT01804075)
- Testing
- Methadone, Morphine
- Volunteers
- 31 people
- Sponsor
- Eastern Maine Medical Center
Tobacco Dependence, Withdrawal Symptoms
Varenicline OTC Trial on Efficacy and Safety
The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
- Conditions
- Tobacco Dependence, Withdrawal Symptoms, Smoking Cessation
- Trial name
- VOTC (NCT03557294)
- Testing
- 1.0mg Varenicline b.i.d., 0.5mg Varenicline b.i.d.
- Where
- 2 sites in United States
- Volunteers
- 313 people, healthy volunteers welcome
- Sponsor
- Arizona State University
Marijuana Dependence
Effectiveness Study of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal
This treatment study is targeted specifically for those who want to stop using marijuana. We want to find out if patients who are dependent on marijuana and want to stop using are helped by a combination of the drug dronabinol…
- Trial name
- NCT00480441
- Testing
- Dronabinol, BRENDA therapy
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- University of Pennsylvania
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 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
Marijuana Dependence
Nicotine Patch for Marijuana Withdrawal
The purpose of this 3-year trial is to test the efficacy of transdermal nicotine patch versus placebo patch on marijuana withdrawal symptoms in cannabis-dependent individuals, using a randomized, double-blind, and…
- Trial name
- NMW (NCT01400243)
- Testing
- Nicotine
- Where
- United States
- Volunteers
- 127 people
- Sponsor
- Southern Illinois University Carbondale
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)
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
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
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
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)
Nicotine Dependence
Nicotine Replacement Therapy (NRT) and Bupropion Mechanisms of Effectiveness in Smokers
The purpose of this study is to better characterize differences in mood, attention, brain activation patterns underlying the beneficial effects of pharmacological treatments previously demonstrated to be help individuals…
- Trial name
- NCT01048944
- Testing
- Bupropion SR, Nicotine Patch
- Where
- United States
- Volunteers
- 197 people
- Sponsor
- Southern Illinois University Carbondale