Clinical trials: Opioid Withdrawal
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 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)
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
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
Osteoarthritis of the Knee
A Phase 2 Study To Assess The Efficacy, Tolerability, And Safety OF NKTR-181 In Subjects With Chronic OA Knee Pain
NKTR-181 is being developed as an analgesic compound for the treatment of moderate to severe chronic pain - active as a mu agonist, but with inherent molecular properties designed to provide a unique clinical profile, including…
- Trial name
- NCT01619839
- Testing
- NKTR-181
- Where
- 34 sites in United States
- Volunteers
- 296 people
- Sponsor
- Nektar Therapeutics
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
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
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
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 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
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.
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
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
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
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
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
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
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