Clinical trials: Opioid Use Disorders
Chronic Pain, Pain
A Study of Cebranopadol for Opioid Withdrawal Symptoms in Adults With Chronic Pain
This Phase 2 study will evaluate whether multiple doses of cebranopadol suppress opioid withdrawal signs and symptoms compared with placebo in adults with chronic pain who are physically dependent on prescribed opioids.
- Conditions
- Chronic Pain, Pain, Opioid Withdrawal (Disorder), Opioid Use Disorder
- Trial name
- NCT07874620
- Testing
- Cebranopadol
- Where
- 2 sites in United States
- Volunteers
- 45 people
- Sponsor
- Adneuris Therapeutics, 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
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
- 61 sites in United States, Canada and 2 more
- Volunteers
- 465 people
- Sponsor
- Eli Lilly and Company
Opioid Use Disorder
iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers
This Phase 1b clinical study is evaluating iSTEP-N, an investigational extended-release implant containing naltrexone, a medication used to block the effects of opioids.
- Trial name
- iSTEP-N (NCT07064564)
- Testing
- Naltrexone implant, 14.4 grams, Naltrexone implant, 9.6 grams, Extended-release naltrexone injection, 380 mg
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Akyso Therapeutics, LLC
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
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
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
Treatment for Opioid Use Disorder
A Study to Train a Machine Learning Algorithm for an Evaluation of the Use of Biometric Data Captured at the Wrist for the Identification of Acute Opioid Use Events and the Quantification of Opioid Withdrawal in Opioid Dependent Individuals
To train a machine learning model/algorithm for an evaluation of the use of biometric data captured at the wrist for the identification of acute opioid use events and the quantification of opioid withdrawal in opioid dependent…
- Trial name
- NCT07405398
- Testing
- Train and evaluate the accuracy and reliability of the Strength Band Platform in identifying acute opioid dosing events from time-stamped biometric data collected from wrist-worn devices.
- Where
- United States
- Volunteers
- 420 people, healthy volunteers welcome
- Sponsor
- OpiAID
Opioid Use Disorder
A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine
This study is open to people between 18 and 65 years of age with opioid use disorder. Opioid use disorder is also called opioid addiction or opioid dependence.
- Trial name
- NCT06628622
- Testing
- BI 1356225
- Where
- 5 sites in United States
- Volunteers
- 12 people
- Sponsor
- Boehringer Ingelheim
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
A Project to Test the Efficacy and Safety of An Innovative Treatment for Opiate Use Disorders.
Investigators will test, for safety and efficacy, a novel treatment for opiate addiction that applies a 4-minute treatment of intense near infra-red light to stimulate a side of the brain that the investigators determine to be…
- Trial name
- NCT05995873
- Testing
- transcranial photobiomodulation at 810 nm at 250 mW/cm2 for 4 minutes
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- MindLight, LLC
Opioid Use Disorder
Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults
The purpose of this study is to evaluate the safety and blood levels of a medicine, naltrexone, contained within an implant in healthy volunteers age 18 to 65 years.
- Trial name
- NCT06216132
- Testing
- BIOPIN-6 Active Implant with Naltrexone
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Akyso Therapeutics, LLC
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
Moderate to Severe Opioid Use Disorder
INDV-6001 Multiple-Dose Pharmacokinetic Study
This is a multicentre, open-label, multiple dose study of INDV-6001 in adult participants with moderate or severe OUD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5).
- Trial name
- NCT06576843
- Testing
- INDV-6001, Suboxone, Sublocade
- Where
- 11 sites in United States
- Volunteers
- 123 people
- Sponsor
- Indivior Inc.
Moderate to Severe Opioid-use Disorder
Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users
The primary objective of the induction phase of the study is to compare treatment retention of participants following rapid induction or standard of care (SoC) induction onto extended-release buprenorphine.
- Trial name
- NCT04995029
- Testing
- Transmucosal Buprenorphine, Extended-release Buprenorphine
- Where
- 29 sites in United States, Canada
- Volunteers
- 785 people
- Sponsor
- Indivior Inc.
Opioid Use Disorder
Reward-based Technology to Improve OUD Treatment
Millions of people in the US misuse opioids each year. Medication assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious, but only a fraction of OUD persons access MAT, and treatment non-adherence is common…
- Trial name
- OARSCM (NCT05180669)
- Testing
- OARSCM Software Application, MyMAT Software Application
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Q2i, LLC
Opioid Use Disorder
Evaluating the SUBLOCADE Treatment Exit Strategy
The purpose of this study is to observe and assess the successful taper and opioid withdrawal experience after participants stop receiving SUBLOCADE because their healthcare provider determines their disease symptoms have been…
- Trial name
- NCT05878210
- Where
- 2 sites in United States, Canada
- Volunteers
- 12 people
- Sponsor
- Indivior Inc.
Opioid Use Disorder
Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use Disorder
The purpose of this study is to measure safety and efficacy and to determine dose-response relationship for INDV-2000 in participants with moderate to severe Opioid Use Disorder (OUD) who are new to treatment, have recently…
- Trial name
- NCT06384157
- Testing
- INDV-2000
- Where
- 35 sites in United States
- Volunteers
- 300 people
- Sponsor
- Indivior Inc.
Opioid Use Disorder
Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms
The purpose of this prospective study is to investigate the efficacy of the Bridge™ device in reducing the symptoms of opioid withdrawal in a blind comparison to a sham device.
- Trial name
- NCT05924945
- Testing
- Bridge™ active device
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Masimo Corporation
Opioid Use Disorder
SUBLOCADE Long-term Outcomes
This study will provide the opportunity to generate data on the long-term use of SUBLOCADE under real-world conditions, and to observe enduring changes in lifestyle, health, and sociodemographic factors that are part of the…
- Trial name
- NCT05860959
- Where
- 49 sites in United States, Australia and 2 more
- Volunteers
- 480 people
- Sponsor
- Indivior Inc.