Clinical trials: Opioid Withdrawal (Disorder)
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 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 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
Opioid Withdrawal (Disorder), Opioid Use Disorder
A Pharmacokinetic, Safety, and Tolerability Study of LUCEMYRA in the Treatment of Opioid Withdrawal Management in Adolescent Subjects
The goal of this clinical study is to evaluate the pharmacokinetic (PK), safety, and tolerability of LUCEMYRA in adolescents age ≥12 to <18 years old abruptly discontinuing opioid use.
- Trial name
- NCT06711640
- Testing
- LUCEMYRA (lofexidine) tablets
- Where
- United States
- Sponsor
- USWM, LLC (dba US WorldMeds)
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.
Opioid-use Disorder, Opioid Withdrawal
Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder
The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone during Phase II.
- Trial name
- RESTORE (NCT05053503)
- Testing
- Sparrow Ascent Therapy System, Lofexidine, Extended-release injectable naltrexone
- Where
- 4 sites in United States
- Volunteers
- 108 people
- Sponsor
- Spark Biomedical, Inc.
Opioid Use Disorder, Opioid Withdrawal
Suboxone Dispenser for OUD
The goal of this study is to evaluate the usability and acceptability of the Addinex system with patients receiving Suboxone in OUD treatment.
- Trial name
- NCT05790551
- Testing
- Addinex
- Where
- United States
- Sponsor
- Addinex Technologies, Inc.
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)
Opiate Withdrawal Syndrome
A Study of Oral Ibogaine in Opioid Withdrawal
Study DMX-IB 201 is a Phase 1/2a study of ibogaine consisting of an initial single ascending dose escalation stage to determine the maximum tolerated dose (MTD) or treat-to-target dose (TTD) in healthy volunteers, followed by a…
- Trial name
- NCT05029401
- Testing
- DMX-1002
- Where
- 2 sites in United Kingdom
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- atai Therapeutics, Inc.
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)
Opioid-use Disorder, Opioid Withdrawal
Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal
Clinical performance data for transcutaneous auricular neurostimulation (tAN) as a method to aid in the reduction of symptoms associated with opioid withdrawal in order to support clinical substantial equivalence to a predicate…
- Trial name
- NCT04075214
- Testing
- transcutaneous auricular neurostimulation (tAN)
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Spark Biomedical, Inc.
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.
Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe
Computerized Chemosensory-Based Orbitofrontal Cortex (CBOT) for Opioid Use Disorder
Opioid Use Disorders (OUD) cause significant burden to individuals, families, and the society. Our product - Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) - offers a cost-saving, home-based, user-friendly…
- Conditions
- Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe, Withdrawal Symptoms, Craving
- Trial name
- CBOT-OUD (NCT04850664)
- Testing
- CBOT + TAU
- Where
- 4 sites in United States
- Volunteers
- 190 people
- Sponsor
- Evon Medics LLC
Addiction, Opioid Dependence
Exploratory Dose Ranging Study Assessing APH-1501 for the Treatment of Opioid Addiction
The purpose of this study is determine the safety, efficacy and tolerability of a novel drug APH-1501 as a pharmacotherapy for Opioid Dependence. The investigators will evaluate the safety of escalating doses APH-1501.
- Conditions
- Addiction, Opioid Dependence, Opioid Withdrawal
- Trial name
- NCT03813095
- Testing
- APH-1501
- Volunteers
- 32 people
- Sponsor
- Aphios
Pain, Pain, Acute
Assessing Opioid Care Practices Using CPV Patient Simulation Modules
This study will test the quality of opioid-related physician care decisions using a patient-simulation based measurement and feedback approach that combines multiple-choice care decisions with real-time, personalized scoring and…
- Conditions
- Pain, Pain, Acute, Pain, Chronic, Pain, Neuropathic
- Trial name
- NCT04080037
- Testing
- Quality IQ Patient Simulations
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Qure Healthcare, LLC
Opioid Dependence, Methadone Withdrawal Syndrome
Pilot Study of Lofexidine and Methadone Pharmacodynamic Interaction in Methadone Maintained Patients
The primary objective of this study is to assess QTc (an interval of the heart rhythm) interaction effects between lofexidine and methadone.
- Trial name
- NCT01558934
- Testing
- Lofexidine HCl
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Opioid Dependence, Buprenorphine Withdrawal Syndrome
Pharmacokinetic & Pharmacodynamic Interaction of Lofexidine and Buprenorphine in Buprenorphine Maintained Patients
The primary objective of this study is to assess lofexidine related effects on QTc (an interval of the heart rhythm) in subjects receiving buprenorphine maintenance.
- Trial name
- NCT01820442
- Testing
- Lofexidine HCl, Lofexidine-matching sugar pill
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Opioid Dependence, Methadone Withdrawal Syndrome
Main Study of Lofexidine and Methadone Pharmacodynamic Interaction in Methadone Maintained Patients
The primary objective of this study is to assess QTc (an interval of the heart rhythm) interaction effects between lofexidine and methadone.
- Trial name
- NCT01650649
- Testing
- Lofexidine HCl, Lofexidine-matching sugar pill
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Substance Withdrawal Syndrome, Opiate Addiction
Study to Evaluate the Exposures of Lofexidine and Its Major Metabolites in Subjects Seeking Buprenorphine Dose Reduction
The purpose of this study is to evaluate the relative exposures of lofexidine and its major metabolites in subjects seeking buprenorphine dose reduction.
- Conditions
- Substance Withdrawal Syndrome, Opiate Addiction, Opiate Dependence
- Trial name
- NCT02801357
- Testing
- lofexidine administration in subjects seeking buprenorphine dose reduction
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- USWM, LLC (dba US WorldMeds)