Clinical trials: Opioid Withdrawal
Low Back Pain
Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain
The primary objective of this study is to evaluate the efficacy of hydrocodone bitartrate extended-release tablets at doses of 30 to 90 mg every 12 hours compared with placebo in alleviating moderate to severe pain in patients…
- Trial name
- NCT01789970
- Testing
- Hydrocodone ER
- Where
- 87 sites in United States
- Volunteers
- 625 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Withdrawal Symptoms
A Study to Evaluate Withdrawal Effects Following Dosing of Oxycodone/Naltrexone in Methadone-Maintained Subjects
This single-center study is a randomized, double-blind, active-controlled, multiple-dose, parallel group study to evaluate the potential withdrawal effects, safety and tolerability, and pharmacokinetic and pharmacodynamic effects…
- Trial name
- NCT02391571
- Testing
- Oxycodone/Naltrexone Capsules, Oxycodone
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Elite Laboratories, Inc
Neonatal Abstinence Syndrome
Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome
To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.
- Trial name
- NAS (NCT00510016)
- Testing
- Clonidine HCL
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- National Institute on Drug Abuse (NIDA)
Opioid Use Disorder
Dronabinol and Epidiolex to Manage Uncontrolled Residual Symptoms of Buprenorphine Initiation Trial
The goal of this pilot study is to test novel, adjunctive pharmacotherapy for patients with opioid use disorder (POUD) who may be at risk for overdose and other poor opioid use disorder (OUD) outcomes even after initiating…
- Trial name
- DEMURE (NCT07148206)
- Testing
- Dronabinol Capsules, Epidiolex 100 mg/mL Oral Solution
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Montefiore Medical Center
Opioid Use, Opioid-Related Disorders
Surviving Opioid Overdose With Naloxone Education and Resuscitation Trial (SOONER)
Among people at risk of opioid overdose and receiving care in an academic emergency department, family practice, opioid substitution clinic or general inpatient units, does brief opioid overdose resuscitation training and…
- Conditions
- Opioid Use, Opioid-Related Disorders, Opioid Withdrawal, Opioid Overdose
- Trial name
- SOONER (NCT04740099)
- Testing
- SOONER Video & Kit, Standard of Care
- Where
- Canada
- Volunteers
- healthy volunteers welcome
- Sponsor
- Unity Health Toronto
Opiate Dependence, Drug Dependence
Treatment of Polydrug-Using Opiate Dependents During Withdrawal
Managed detoxification is a first and necessary step prior to treatment and rehabilitation. Detoxification can be a major obstacle for some patients, and the availability of managed and safe withdrawal is a prerequisite for…
- Conditions
- Opiate Dependence, Drug Dependence, Substance Withdrawal Syndrome
- Trial name
- NCT00367874
- Testing
- Buprenorphine, Valproate
- Where
- Norway
- Volunteers
- 12 people
- Sponsor
- Sorlandet Hospital HF
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.
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
Opioid Use Disorder, Opioid Withdrawal
Sublingual Dexmedetomidine for Treating Opioid Withdrawal
A major challenge to seeking treatment for opioid use disorder (OUD) is the withdrawal symptoms associated with cessation of opioid use.
- Trial name
- NCT05712707
- Testing
- BXCL501 (180 micrograms), BXCL501 (240 micrograms), Lofexidine (Positive Control)
- Where
- 4 sites in United States
- Volunteers
- 160 people
- Sponsor
- New York State Psychiatric Institute
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
High Dosage Buprenorphine
High Dosage Buprenorphine as a Drug Strategy Withdrawal Assistance of Analgesics Opioid
The prevalence of analgesics opioids addiction in chronic pain patient is very difficult to know. Many studies indicated that the prevalence of addiction varied from 0% up to 50% in chronic non cancer pain patients, and from 0%…
- Trial name
- SEVROP (NCT03156907)
- Testing
- Buprenorphine
- Where
- France
- Volunteers
- 60 people
- Sponsor
- University Hospital, Clermont-Ferrand
Opioid-use Disorder, Opioid Withdrawal
Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal
The objective of this study is to evaluate whether tAN via the tragus (vagal) and auriculotemporal (trigeminal) nerve pathways results in a clinically meaningful reduction in opioid withdrawal symptoms.
- Trial name
- NCT04731935
- Testing
- Sparrow Therapy System
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Spark Biomedical, Inc.
Withdrawal Syndrome, Iatrogenic Disease
AduLt iatrogEnic withdRawal sTudy in the ICU (ALERT-ICU)
Withdrawal from opioids and sedatives administered for medical purposes (i.e. iatrogenic withdrawal) often goes unrecognized in the critically ill, but its prevalence is high.
- Trial name
- NCT04422808
- Where
- United States
- Volunteers
- 2,437 people
- Sponsor
- Wilkes 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
- 120 people
- Sponsor
- Tufts Medical Center
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome
Infants with neonatal abstinence syndrome (NAS) experience prolonged hospital stays and poor neurodevelopmental outcomes, in-part because of the lack of accurate, individualized, biologic assessments available to manage this…
- Trial name
- NCT05937594
- Testing
- Buccal swab saliva for further genetic testing
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Milton S. Hershey Medical Center
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 (Disorder), Opioid Use Disorder
Evaluation of a Physical Device for Medical Use (ADTPM 1) for Opioid Withdrawal Symptoms
This study aims to evaluate the safety and efficacy of a physical device for medical use (ADTPM 1) applied to opioid withdrawal symptoms.
- Trial name
- NCT07079215
- Testing
- Neurostimulation
- Where
- South Korea
- Volunteers
- 24 people
- Sponsor
- Nu Eyne Co., Ltd.
Chronic Pain, Drug Dependence of Morphine Type
Novel Use of Probenecid to Alleviate Symptoms of Opioid Withdrawal
The proposed clinical trial will address the problem of opioid withdrawal. Opioids are essential for pain-relief in the short term, but their continued use is associated with a host of adverse effects.
- Conditions
- Chronic Pain, Drug Dependence of Morphine Type, Symptom, Withdrawal
- Trial name
- NCT04939623
- Testing
- Probenecid
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- University of Calgary
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 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