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Opioid Withdrawal clinical trials

View clinical trials related to Opioid Withdrawal.

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NCT ID: NCT05790551 Recruiting - Opioid Use Disorder Clinical Trials

Suboxone Dispenser for OUD

Start date: March 2024
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate the usability and acceptability of the Addinex system with patients receiving Suboxone in OUD treatment. The main questions it aims to answer are: - Are patients more likely to stay on their medication? - Is the risk of diversion being reduced? - How is the usability of the Addinex system for doctors and patients?

NCT ID: NCT05712707 Recruiting - Opioid Use Disorder Clinical Trials

Sublingual Dexmedetomidine for Treating Opioid Withdrawal

Start date: February 28, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

A major challenge to seeking treatment for opioid use disorder (OUD) is the withdrawal symptoms associated with cessation of opioid use. The signs and symptoms of opioid withdrawal include irritability, anxiety, muscular and abdominal pains, chills, nausea, diarrhea, yawning, runny eyes and nose, sweating, sneezing, weakness, and insomnia. The current gold standard of treatment involves a gradual reduction of the opioid drug dosage (tapering). However, as all opioids have potential for abuse and require careful dosing due to side effects (e.g., respiratory depression), a non-opioid medication to facilitate withdrawal severity would be of great value. Commonly used non-opioid medications like lofexidine have concerning side effects including sedation and low blood pressure. BioXcel Therapeutics has developed BXCL501 (dexmedetomidine: sublingual film) to reduce symptoms associated with opioid withdrawal. Dexmedetomidine is currently used as an intravenous anesthetic for its anxiety-reducing, sedative, and analgesic properties. The current study will seek to compare the safety and efficacy of BXCL501 relative to lofexidine and placebo in subjects with OUD who are physically dependent on opioids. Throughout a 7-day inpatient withdrawal period (using a methadone taper) opioid-dependent participants will receive sublingual BXCL501, placebo, or lofexidine. In comparison to lofexidine, dexmedetomidine is expected to have a superior safety profile with limited adverse effects on blood pressure and heart rhythm. Three sites will participate in this study: NYSPI, Clinilabs, Inc., and Yale University.

NCT ID: NCT05555485 Recruiting - Analgesia Clinical Trials

Understanding the Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain

Start date: May 24, 2023
Phase: N/A
Study type: Interventional

The purpose of the study is to find out how a stimulation device worn on the ear works. This device is thought to stimulate nerves in the area around the ear to change the signals in the brain. The device has been shown to reduce pain and to reduce the symptoms of withdrawal. The investigator will also investigate changes in the way each participant perceive sensations of pressure and heat. The participant will be asked to reduce the amount of pain medication that they take. Then, the participant will spend several days and nights in the Clinical Research Center at UTMB (University of Texas Medical Branch) in Galveston. During that time, the participant will be monitored for withdrawal symptoms and will receive either active (e.g., "real") brain stimulation or sham (e.g., "fake") brain stimulation for two days (four hours each day). At two times over the course of the study (before and after ear stimulation treatment), the participant will complete questionnaires about their pain score and how they are feeling, sensory testing, and will undergo magnetic resonance imaging (MRI) of their brain. The investigator will collect the following information from the participant's medical record: age, gender, medication history, medical diagnoses, recent vital signs, past doctor visits or hospital stays, and results of urine drug tests. Participation in this study will last approximately four days, and the participant will stay in the Clinical Research Center.

NCT ID: NCT05511909 Recruiting - Anxiety Clinical Trials

Evaluating Buspirone to Treat Opioid Withdrawal

Start date: December 15, 2022
Phase: Phase 2
Study type: Interventional

The investigators propose a rigorous, Phase II, three-group, placebo-controlled double-blind randomized controlled trial (RCT) to evaluate the efficacy of buspirone for both withdrawal and craving among individuals with opioid use disorder (OUD) undergoing a standardized stepwise taper. During this 10 to 12-day residential study, participants with OUD will be enrolled, stabilized on a short-acting opioid, undergo an opioid stepwise taper, and complete a post-taper observation period where participants will have the opportunity to initiate long-term buprenorphine or extended-release naltrexone.

NCT ID: NCT05307458 Recruiting - Opioid Use Disorder Clinical Trials

Evaluating the Pharmacokinetics and Patient Outcomes of Buprenorphine Microdosing

Start date: July 1, 2022
Phase:
Study type: Observational

There are more than 2.1 million people in the United States with opioid use disorder, and according to preliminary data from the US Centers for Disease Control and Prevention opioid overdose deaths rose 36% to more than 69,000 deaths in 2020. Treatment with buprenorphine or methadone reduces overdose deaths in patients with opioid use disorder. However, most patients with opioid use disorder do not receive treatment. In addition to the rising rates of morbidity and mortality, the healthcare, social, and societal costs of the opioid epidemic are roughly one trillion dollars annually. Rapidly scalable strategies are needed to increase access to treatment and improve treatment retention. The investigators propose a novel buprenorphine micro-dosing study to evaluate the pharmacokinetics, treatment retention, and qualitative outcomes in participants transitioning from methadone maintenance therapy to buprenorphine using a micro-dosing initiation in the outpatient setting. The proposed study will report participant pharmacokinetics, treatment retention, Clinical Opiate Withdrawal Scale (COWS) score, Treatment Satisfaction Questionnaire for Medication (TSQM) score, and other qualitative outcomes.

NCT ID: NCT05053503 Recruiting - Opioid-use Disorder Clinical Trials

Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder

RESTORE
Start date: May 25, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05027919 Recruiting - Opioid Use Disorder Clinical Trials

Assessing a Clinically-meaningful Opioid Withdrawal Phenotype

Start date: February 1, 2022
Phase: Phase 2
Study type: Interventional

Evaluate individual differences in the expression of opioid withdrawal symptoms in persons with opioid use disorder (OUD) while completing a clinically-indicated medication taper.

NCT ID: NCT04759703 Recruiting - Opioid-use Disorder Clinical Trials

Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD

Start date: January 24, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The investigators propose to test the use of pramipexole in patients being treated for Opioid Use Disorder to test its ability to reduce symptoms of both Restless Legs Syndrome and protracted opioid withdrawal and thereby promote initiation, engagement, and retention in treatment.

NCT ID: NCT04740099 Withdrawn - Opioid Use Clinical Trials

Surviving Opioid Overdose With Naloxone Education and Resuscitation Trial (SOONER)

SOONER
Start date: December 2021
Phase: N/A
Study type: Interventional

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 naloxone distribution reduce resuscitation failures in a simulated overdose even, in comparison with standard-of-care referral to a local OEND program, within 14 days post-intervention? Can an integrated participant recruitment and retention strategy recruit approximately 28 eligible participants within 4 weeks and maintain less than 50% attrition rates in the context of a randomized trial on point-of-care OEND and simulated overdose resuscitation performance in family practice, emergency department, and addictions settings?

NCT ID: NCT04731935 Completed - Opioid-use Disorder Clinical Trials

Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal

Start date: March 18, 2021
Phase: N/A
Study type: Interventional

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.