Clinical trials: Opioids, open to volunteers
Opioid-induced Constipation
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
The research objective is to characterize the risk of a major adverse cardiovascular event (MACE) among new users of naldemedine versus new users of lubiprostone and new users of naloxegol as comparator opioid induced…
- Trial name
- NCT03720613
- Testing
- Naldemedine, Lubiprostone, Naloxegol
- Where
- United States
- Volunteers
- 34,532 people
- Sponsor
- BioDelivery Sciences International
Opioid Use Disorder
Brain Training for Substance Use Disorders
Participants play games designed to train visual attention towards natural, non-drug-related scenarios. A biofeedback loop between gameplay and an electroencephalogram (EEG) system monitors game performance and guides game…
- Trial name
- NCT06870110
- Testing
- Bias Modification Biofeedback
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Neurotype Inc.
Opioid Use Disorder
Evaluation of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent Persons
This study will examine the safety and efficacy of the O'Neil Long Acting Naltrexone Implant (OLANI) in persons with opioid dependency who are seeking relapse-prevention treatment.
- Trial name
- GM0020 (NCT05382091)
- Testing
- naltrexone implant
- Volunteers
- 250 people
- Sponsor
- Go Medical Industries Pty Ltd
Post Surgical Respiratory Failure, Respiratory Complication
Clinical Evaluation of an Alarm Activated Detection System to Enable Early Intervention of Emerging Respiratory Decline With the Linshom Medical Continuous Predictive Respiratory Sensor (CPRS)
Investigators will enroll 493 patients who will undergo non-cardiac surgery, receive supplemental oxygen via face mask or nasal cannula, and will be on continuous pulse oximetry monitor in the Post Anesthesia Care Unit (PACU).
- Conditions
- Post Surgical Respiratory Failure, Respiratory Complication, Opioid Induced Respiratory Depression, Respiratory Arrest
- Trial name
- NCT07793981
- Testing
- Linshom Continuous Predictive Respiratory Monitoring
- Where
- 2 sites in United States
- Volunteers
- 394 people
- Sponsor
- Linshom Medical, Inc.
Opioid Withdrawal, Opioid Use Disorder
Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder
The primary objective of this trial is to measure changes in physiologic signals to quantify the status of the autonomic nervous system during opioid withdrawal and cravings.
- Trial name
- NCT06487533
- Testing
- EmbracePlus Smartwatch, Corti Sensor
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Spark Biomedical, Inc.
Opioid Use Disorder
PEX010-Assisted Therapy for Opioid Use Disorder (OUD): a Feasibility Study
The goal of this clinical trial is to learn if it is feasible to use PEX010 for the treatment of opioid use disorder in adults. The study will also assess the safety of PEX010.
- Trial name
- NCT06608459
- Testing
- PEX010-Assisted Therapy
- Volunteers
- 10 people
- Sponsor
- Filament Health Corp.
Opioid-Induced Respiratory Depression, Postoperative Complications (Cardiopulmonary)
Pupillometry in Identifying Risk of Postoperative Opioid-induced Respiratory Depression in Children Undergoing Tonsillectomy
This study will evaluate whether quantitative pupillometry measurements can be used to identify children at risk for postoperative opioid-induced respiratory depression (OIRD) following tonsillectomy.
- Conditions
- Opioid-Induced Respiratory Depression, Postoperative Complications (Cardiopulmonary), Respiratory Complications Due to Anesthesia
- Trial name
- NCT07573150
- Testing
- Infrared Pupillometry
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- NeurOptics Inc
Opioid Use Disorder
Remotely Observed Methadone Evaluation II
Methadone is an effective treatment for severe opioid use disorder (OUD), but access is limited due to the requirement of daily observed dosing by most opioid treatment programs (OTPs).
- Trial name
- ROME II (NCT06338280)
- Testing
- Sonara
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Sonara Health
Opioid-Induced Constipation (OIC)
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive…
- Trial name
- NCT05588323
- Testing
- Naldemedine
- Where
- 16 sites in Albania, Armenia and 6 more
- Volunteers
- 24 people
- Sponsor
- Shionogi
Opioid Use Disorder
A Study of Brenipatide in Participants With Opioid Use Disorder
The purpose of this study is to see if brenipatide, when compared to placebo, is safe and effective for participants with opioid use disorder, when used with buprenorphine with or without naloxone.
- Trial name
- RENEW-Op-1 (NCT07420283)
- Testing
- Brenipatide, Buprenorphine
- Where
- 68 sites in United States, Canada and 2 more
- Volunteers
- 465 people
- Sponsor
- Eli Lilly and Company
Opioid Abuse and Addiction
Nalmefene Implant in Healthy Subjects
The goal of this clinical trial is to learn how safe either one or two nalmefene implants are after remaining implanted for 4 or 12 weeks.
- Trial name
- NCT07325279
- Testing
- 1 Nalmefene implant, 2 Nalmefene implants
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ReacX Pharmaceuticals, Inc.
Opioid Use Disorder, Opioid Withdrawal
Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder
IBO-CARE is a single-site Phase 1/2a study evaluating the safety, tolerability, feasibility and preliminary outcomes of medically supervised ibogaine with 12 months of recovery support in adults with moderate-to-severe opioid use…
- Conditions
- Opioid Use Disorder, Opioid Withdrawal, Substance Use Disorders
- Trial name
- IBO-CARE (NCT07871877)
- Testing
- Ibogaine Hydrochloride, Extended-release naltrexone injection, 380 mg, My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Clive Michelsen
Opioid-use Disorder, Substance Use Disorders
Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)
The purpose of this clinical trial is to investigate Low Intensity Focused Ultrasound (LIFU) using the Exablate® Model 4000 Type 2.0/2.1 as an adjunctive neuromodulatory treatment for OUD (Opioid Use Disorder) and/or other…
- Trial name
- NCT04197921
- Testing
- Exablate Model 4000 Type 2.0/2.1
- Where
- 4 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- InSightec
Opioid Use Disorder
Right Tools, Right Time, Right Place: Telehealth for Opioid Use Disorder in Vulnerable Settings
Our primary objective is to evaluate the ability of Boulder Care's telehealth-platform to create the necessary paradigmatic shift in Opioid Use Disorder (OUD) treatment to reach vulnerable populations, with targets that support…
- Trial name
- NCT07169409
- Testing
- Telemedicine Buprenorphine Treatment
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Boulder Care
Opioid Dependence, Alcohol Dependence
A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.
A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.
- Conditions
- Opioid Dependence, Alcohol Dependence, Multiple Sclerosis
- Trial name
- NCT05620940
- Testing
- Vivitrol Injectable Product, IVL3004, IVL4002
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Inventage Lab., Inc.
Opioid Use Disorder
Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder
This study is examining the use of Tezampanel (TZP) for treatment of Opioid Withdrawal Syndrome (OWS) in participants with Opioid Use Disorder (OUD).
- Trial name
- NCT06538558
- Testing
- Tezampanel
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Proniras Corporation
Thoracic Surgery, Pneumonectomy
Personalized Postoperative Pain Management Following Thoracic Surgery in Adults
The proposed research is an important extension of an ongoing perioperative personalized analgesia and intravenous opioid pharmacogenetic research.
- Conditions
- Thoracic Surgery, Pneumonectomy, Lobectomy, Segmentectomy
- Trial name
- NCT05525923
- Where
- 4 sites in United States
- Volunteers
- 200 people
- Sponsor
- OpalGenix, Inc
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)
A Phase II Trial for MOR Antagonism With Axelopran to Enhance Immunotherapy in Head and Neck Cancer
This Phase 2, open-label, multicenter study will evaluate the safety and preliminary efficacy of axelopran in combination with pembrolizumab in patients with PD-L1 positive recurrent or metastatic head and neck squamous cell…
- Trial name
- MORALE-HN01 (NCT07662720)
- Testing
- axelopran, Pembolizumab
- Volunteers
- 18 people
- Sponsor
- Glycyx Therapeutics
Opioid Use Disorder
AvertD Post-Approval Study
A Prospective Post-Approval Study of AvertD to Evaluate Device Performance, Prescribing Impact, and Labeling Comprehension in the Intended Use Population
- Trial name
- NCT07135323
- Testing
- Opioid Used Disorder Risk Assessment
- Where
- United States
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- Prescient Medicine Holdings, Inc.
Wisdom Teeth, Wisdom Teeth Extraction or Jaw Implant
NeuroCuple to Mitigate Post-Wisdom Teeth Extraction Opioid Risks
This is a randomized (1:1), placebo-controlled clinical trial that will examine the feasibility and effectiveness of a 2-day application of the NeuroCuple device for pain relief and reduction of opioid use following wisdom teeth…
- Trial name
- NCT07461506
- Testing
- NEUROCUPLE™ Patch
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- nCap Medical