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Opioid-use Disorder clinical trials

View clinical trials related to Opioid-use Disorder.

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NCT ID: NCT04033562 Terminated - Pregnancy Related Clinical Trials

The Analgesic Efficacy of Continuous Sub-fascial Bupivacaine Infusion and Lidocaine Patches in Post-cesarean Patients With Opiate Use Disorder: A Comparative Efficacy Analysis

Start date: January 15, 2020
Phase: Phase 4
Study type: Interventional

Pregnant women with a history of opioid use disorder, chronic opioid use or those who are on medication assisted treatment will be randomly assigned to receive either a sub-fascial continuous infusion of bupivacaine or lidocaine/menthol patch after Cesarean delivery. Post-operative pain scores and opioid usage in the post-operative period will be recorded.

NCT ID: NCT04025671 Completed - Opioid-use Disorder Clinical Trials

A Usability Assessment of Naloxone Administration by Untrained Community Members

Start date: August 23, 2017
Phase: N/A
Study type: Interventional

This will be a randomized, open-label, usability assessment of intramuscular, intranasal, and nasal spray administration of naloxone using two different instruction sets by laypersons. - Design: Single site, open-label, randomized usability assessment of intramuscular, intranasal, and nasal spray administration of simulated naloxone. A convenience sample of participants will consent to volunteer in the study at a public venue. Participants will provide verbal consent and will be randomly assigned a simulated naloxone kit containing either intramuscular, intranasal, or nasal spray administration materials with either standard or study team designed instructions for use. Participants will enter a use scenario station and be asked to assemble and administer the simulated naloxone kit to a mannequin (intranasal and nasal spray) or simulated flesh pad (intramuscular). The participant will be instructed to start and will be timed until the simulated naloxone has been successfully administered or 7 minutes has elapsed. The participant will be observed by one trained investigator who will assess for successful administration of the simulated naloxone and critical errors. The environment will contain distractors.Once the participant has successfully administered simulated naloxone or 7 minutes elapses the timer will be stopped. Successful administration of simulated naloxone will be defined as administration of the agent without any critical errors occurring (defined below). Data collected will include demographics (defined below), successful administration of simulated naloxone, time to successful administration of simulated naloxone, and Likert-item data assessing the ease of use of the device and instructions. - Participants: adults (18 years of age and older) at a public venue will be asked to volunteer. Participants with severe visual or hearing impairment (defined as: legally deaf, legally blind, unable to read print size provided on instructional handout, or unable to hear video audio), that have previous naloxone administration training, that are not English proficient, that are pregnant, or that have previously participated in the trial will be excluded. - Kits: 1. Intranasal: simulated naloxone vial, bristoject, administration instructions (standard or study team designed) 2. Intramuscular: sterile single use needle, sterile single use 3 mL syringe, simulated naloxone vial, administration instructions (standard or study team designed) 3. Nasal spray: simulated naloxone spray, administration instructions (standard or study team designed) - Objectives: 1. Primary: successful administration of simulated naloxone in the time allowed. A successful administration will be defined as administration of the simulated naloxone to the mannequin head of simulated flesh pad within 7 minutes and without any critical errors (defined below). 2. Secondary: time required to successfully administer the simulated naloxone and Likert-item assessment of ease of use of both the device and instructions. - Data and Analysis: 1. The usability trial will be conducted using a convenience sample so no power analysis will be conducted or minimum sample size defined 2. Demographics: age, gender, handedness, level of education, and presence or absence of opioid at risk contacts. 3. Data: successful administration, time to administration, and Likert-item assessment of both the device and instructions. Failure to administer the medication due to a critical use error will be recorded and the specific error reported for all participants. - Critical Errors: 1. Intranasal: failure to remove both yellow caps from bristoject, failure to remove cap from simulated naloxone, failure to attach atomizer, failure to attach simulated naloxone, drug leak prior to administration, administration in only one nostril, and failure to administer within 7 minutes. 2. Intramuscular: failure to attach the needle to the syringe, failure to remove cap from simulated naloxone, failure to draw up >90% (0.9 mL) of the simulated naloxone, failure to puncture simulated flesh pad with needle, failure to push entire volume of fluid in the syringe into the simulated flesh pad, and failure to administer within 7 minutes. 3. Intranasal: failure to place the tip of the device into one nostril, failure to depress the device and release the simulated naloxone, failure to administer within 7 minutes.

NCT ID: NCT04024059 Active, not recruiting - Opioid-use Disorder Clinical Trials

Contingency Management to Enhance Office-Based Buprenorphine Treatment

Start date: January 31, 2020
Phase: N/A
Study type: Interventional

Contingency Management interventions provide incentives to substance abuse patients when patients meet therapeutic goals. This project will compare the effectiveness of two Contingency Management interventions (which the investigators have named "Buprenorphine Adherence and Opiate Abstinence" and "Buprenorphine Adherence Only") and Standard Medical Management for treating adults with opioid use disorder. Participants (N=375) will be randomly assigned to one of the three groups. Buprenorphine Adherence and Opiate Abstinence and Buprenorphine Adherence Only participants will receive incentives for daily buprenorphine use. Buprenorphine Adherence and Opiate Abstinence participants also will receive incentives for providing opiate-negative saliva samples. Daily buprenorphine use and opiate abstinence will both be remotely verified using smartphone-enabled video directly observed therapy (Video DOT). All participants will be receiving or referred to receive buprenorphine treatment and will complete assessments every 4 weeks during a 12-week intervention period.

NCT ID: NCT03993392 Completed - Opioid-use Disorder Clinical Trials

SUBLOCADE Rapid Initiation Study

Start date: August 29, 2019
Phase: Phase 4
Study type: Interventional

This study is to evaluate the safety and tolerability of initiating SUBLOCADEā„¢ treatment following a shorter period of transmucosal (TM) buprenorphine treatment.

NCT ID: NCT03987282 Recruiting - Opioid-use Disorder Clinical Trials

Implementation of STTR Strategies Among People Who Inject Drugs in Malaysia

Start date: April 26, 2022
Phase: N/A
Study type: Interventional

This pragmatic, multisite, implementation and effectiveness research evaluates a strategy to improve HIV treatment outcomes (increased rates of patients on ART with virological suppression, improved treatment retention and ART adherence) for people living with HIV (PLWH) with opioid use disorder (OUD). Engaging 4 large regional HIV/AIDS treatment centers in Malaysia, the study will evaluate barriers and facilitators for implementation of improved care model and will evaluate the comparative effectiveness of the model in a clinical trial. The research will provide critically important evidence for implementation of effective Seek-Test-Treat, and Retain models for PLWH and OUD throughout Malaysia and inform healthcare policy in other low to middle income countries and regions with limited healthcare resources.

NCT ID: NCT03985163 Completed - Opioid-use Disorder Clinical Trials

Patient Reported Outcomes for Opioid Use Disorder

Start date: June 7, 2019
Phase:
Study type: Observational [Patient Registry]

The goal of the project is to build a clinical data research infrastructure that will begin to enhance capacity to use electronic health record (EHR) data and patient reported outcomes measures (PROs) to conduct opioid related research in emergency departments (EDs). 200 adult patients with a history of non-medical opioid use, opioid use disorder, or acute opioid overdose will be enrolled and will be asked to complete three PRO surveys (baseline, 3 days post ED discharge, and 30 days post discharge).

NCT ID: NCT03976258 Completed - Clinical trials for Cardiovascular Diseases

Effect of Heroin Use on Immune Activation and Cardiovascular Risk in HIV

Start date: July 14, 2017
Phase:
Study type: Observational

Despite the advent of safer HIV therapies, high levels of markers of systemic inflammation and increased cardiovascular risk threaten the well-being of individuals living with HIV and present a significant challenge for HIV providers. These risks may be accentuated in HIV-infected individuals who are active intravenous drug users (IVDU); however, this population has been specifically excluded from prior studies assessing immune activation and cardiovascular risk in people living with HIV. In this study, the investigators will specifically target HIV-infected participants who are active IVDU, and co-enroll a control group of HIV-infected participants who never used IV drugs. The investigators will study the specific alterations in immune activation and several mechanisms felt to be potential drivers of immune activation outside of the IVDU population, namely gut integrity alteration, microbial translocation, and oxidized lipids. The investigators will also study the effect of IVDU on markers of arterial inflammation and vascular function. Importantly, the investigators will study the reversibility of immune activation, gut dysfunction, and cardiovascular markers after cessation of IVDU, and to that effect, compare strategies for IVDU cessation-buprenorphine/naloxone versus methadone or vivitrol maintenance treatment.

NCT ID: NCT03971097 Completed - Clinical trials for Alcohol Use Disorder

The Effect of Self-Forgiveness on Self-Stigma in Addiction.

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

This study has an experimental design and will examine the difference in pre-test and post-test data on the Self-Forgiveness Dual Process Scale (SFDPS) (Griffin, Worthington, Davis, Hook, & Maguen, 2018) and the Substance Abuse Self-Stigma Scale (SASSS) (Luoma et al., 2013). Data will be collected from two groups of participants receiving counseling at the short-term rehabilitation facility located at University of Pittsburgh Medical Center's (UPMC). Individuals who agree to participate in the study will be randomly assigned to either the experimental group (EG) or the control group (CG). Data collected will include pre-test SFDPS and SASSS scores for the EG and the CG (collected within 24-hours of admission), and post-test SFDPS and SASSS scores for the EG and CG (collected after 14 days). ANCOVA will be used to analyze the pre-test and post-test data recorded from participants' scores.

NCT ID: NCT03958474 Recruiting - Opioid Use Disorder Clinical Trials

Neurobehavioral Mechanisms of Choice in Opioid Use Disorder

Start date: August 16, 2019
Phase: Early Phase 1
Study type: Interventional

The objective of this protocol is to use probabilistic reinforcement learning choice tasks and magnetic resonance neuroimaging to demonstrate the impact of problematic opioid use and opioid withdrawal on dynamic decision-making and reveal the neurobehavioral and neurobiological processes underlying abnormal task performance. A second objective is to identify an appropriate dose of intravenous remifentanil for subsequent studies in physically dependent individuals with opioid use disorder.

NCT ID: NCT03944850 Completed - Opioid Use Disorder Clinical Trials

Computerized Anxiety Sensitivity Treatment for Opioid Use Disorders

CAST-O
Start date: May 28, 2019
Phase: N/A
Study type: Interventional

The primary aim of the current project is to test the acceptability and feasibility of a computerized intervention, titled Computerized Anxiety Sensitivity Treatment (CAST), delivered to Veterans seeking treatment for an opioid use disorder. The second aim of the study is to examine the utility of CAST by gathering data on symptom change. The final aim of the current study is to test the effects of CAST on rates of attendance and retention in a substance use disorder treatment (SUDT) program.