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Opioid-Related Disorders clinical trials

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NCT ID: NCT03495388 Active, not recruiting - Postoperative Pain Clinical Trials

PG and PK of Oxycodone to Personalize Post-op Pain Management Following Surgery in Children

Start date: April 1, 2018
Phase:
Study type: Observational

Each year, in the U.S. alone, >6 million children undergo painful surgery; up to 50% of them experience significant and serious side effects with opioids and inadequate pain relief. Though 60% of this inter-individual variability in responses results from genetic variations, there is an almost complete lack of understanding of how specific genetic variability affects pain and of the adverse effects of opioids, especially in children. In this project the investigators will focus on oxycodone, a standard and preferred post-surgical oral analgesic in children The purpose of this research is to study serious immediate and long-term clinical problems from both surgical pain and oxycodone use in children and adolescents to improve the safety and effectiveness of surgical pain relief. The long-term goals are to improve the safety and effectiveness of surgical pain relief with opioids (a class of drugs/pain relievers) and to minimize the societal burden of disabling Chronic Persistent Surgical Pain (CPSP, which is pain that persists even after the expected healing time from surgery) and Opioid Dependence (OD) by preoperative risk predictions and personalized care with the right dose of the right pain medication for each child. The overall objective is to determine the impact of risk factors on oxycodone's immediate and long-term negative postoperative outcomes and to personalize dosing in children undergoing outpatient and major inpatient surgery.

NCT ID: NCT03447743 Completed - Opioid Dependence Clinical Trials

Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder

Start date: September 11, 2019
Phase: Early Phase 1
Study type: Interventional

The overall aim of this R34 proposal is to examine the feasibility, acceptability, and short-term outcomes associated with an innovative service delivery model to increase adherence to extended-release naltrexone (XR-NTX) during the transition from jail to the community for rural individuals with opioid use disorder (OUD). The significance of this study is grounded in the public health emergency associated with the opioid epidemic in rural Appalachia, the increased vulnerability of rural individuals with OUD, and the dearth of available and accessible evidence-based treatment in the region. This study has potential to make a significant contribution to the OUD treatment field by advancing knowledge on innovative service delivery models to increase access to evidence-based treatment to reduce the prevalence of opioid use disorders and related health disparities among hard-to-reach, high-risk, underserved populations.

NCT ID: NCT03427424 Terminated - Clinical trials for Opioid-Related Disorders

Imaging Biomarker for Addiction Treatment Outcome

Start date: July 10, 2019
Phase:
Study type: Observational

Background: Many people suffer from drug addiction. But currently, treatments are not very effective. One group of patients in this study are enrolled in addiction treatment through physician health programs (PHPs). About 70% of these patients are able to stop using drugs for extended periods of time. By studying this specific group of patients, researchers want to understand the difference between those who may or may not respond to treatment. They want to study the brain while people do thinking and feeling tasks and when they relax. They will study brain chemicals, a stress hormone, and certain genes. The results may help them understand the brain basis for addiction and recovery. Objectives: To use brain imaging to find differences between people with and without drug addiction. To see if these differences help predict addiction. Eligibility: Healthy, right-handed adults ages 21-65, enrolled in a physician health program or those with no history of addiction and with at least 16 years of education Design: Participants enrolled in a PHP will be screened under this study and participants with no history of addiction will be screened under another study. At the study visit, participants will: Have a routine check-up, including tests for pregnancy, drugs, and alcohol. Give 11 blood samples. Rate their cravings. Test their frustration with stressful situations by responding to questions on a screen. Practice the magnetic resonance imaging (MRI) tasks: Shock task. Two electrodes placed on a foot will deliver brief, low-strength electrical shocks that get gradually stronger, but not painful. Participants will see drug or neutral images. They will rate their discomfort. Thinking tasks. Participants will answer questions about pictures, numbers, and money. They will press buttons in response to things they see. Do the MRI tasks in 2 sessions (morning and afternoon) in the scanner. Participants will lie in an MRI machine which will take pictures of the brain while doing these tasks. Some participants will repeat the visit twice over a year at set intervals. Meals will be provided, and visits will include meal breaks and smoking breaks for those who smoke.

NCT ID: NCT03422211 Completed - Postoperative Pain Clinical Trials

A Prospective Assessment of Opioid Utilization Post-operatively in Sports Orthopaedic Surgeries

Opioids
Start date: November 16, 2017
Phase:
Study type: Observational

There was a study titled "A prospective evaluation of opioid utilization after upper extremity surgical procedures: Identifying consumption patterns and determining prescribing guidelines" by Dr. Matzon and team from Thomas Jefferson University that came up with a simple set of opioid guidelines post-surgically. These guidelines are helping to guide surgeon's prescribing patterns and ideally limit the number of prescribed pain medicines. We plan to identify typical narcotic analgesic usage post sports orthopaedic surgery. We hope to identify the number of narcotic pain pills to prescribe to patients undergoing orthopaedic sports surgery in the future.

NCT ID: NCT03411265 Completed - Clinical trials for Substance Use Disorders

RETAIN: Retaining Opioid Users Entering Medication Assisted Treatment and Encouraging HCV/HIV Testing

RETAIN
Start date: November 8, 2017
Phase: N/A
Study type: Interventional

The purpose of this research study is to: 1. assess how well individuals entering medication assisted treatment like the RETAIN e-health application as measured by their feedback on the intervention. 2. test the impact of RETAIN on knowledge about medication-assisted treatment(MAT). 3. assess treatment retention rates in patients completing the RETAIN intervention. 4. test the impact of RETAIN on knowledge about HCV/HIV 5. test the impact of RETAIN on interest in being tested for HCV/HIV

NCT ID: NCT03407638 Completed - Opioid-use Disorder Clinical Trials

PRimary Care Opioid Use Disorders Treatment (PROUD) Trial

PROUD
Start date: February 28, 2018
Phase: N/A
Study type: Interventional

Effective treatment for opioid use disorders (OUDs) requires medications. Two medications for treating OUDs-buprenorphine and injectable naltrexone-can be prescribed in primary care (PC). However, despite the current opioid epidemic and expert recommendations that OUDs should be treated in PC, most PC clinics do not offer treatment for OUDs. This reflects a lack of consensus among health system leaders and clinicians that OUDs should be treated in PC. The PRimary care Opioid Use Disorders treatment (PROUD) Trial is a pragmatic cluster-randomized, quality improvement trial that evaluates implementation of a team-based approach to PC supported by a full time nurse (the "PROUD intervention"). This type of team-based PC is often referred to as "collaborative care" for management of OUDs in PC, and this type of trial is often referred to as a Hybrid Type III implementation trial. The trial is being conducted in 6 diverse health systems spanning 5 states (New York, Florida, Michigan, Texas, and Washington), with 2 PC clinics in each system randomized. One clinic is randomly selected to implement the PROUD intervention and the other continues usual PC (UPC). The overall objective of the PROUD trial is to provide information to guide health system leaders who are faced with the decision of whether or not to treat OUDs in PC, by evaluating the benefits of implementing the PROUD intervention that integrates high quality OUD treatment (i.e. buprenorphine or injectable naltrexone) into the normal flow of PC. The primary objective of the PROUD trial is to evaluate whether the PROUD intervention increases OUD treatment with buprenorphine or injectable naltrexone, documented in the electronic health records (EHRs) of PC patients, over a 2 year follow-up, as compared to UPC. The primary hypothesis is that there will be a significant increase in the number of patient-days of medication treatment for OUDs documented in the EHR of PC patients in the 2 years after clinics are randomized to the PROUD intervention compared to PC clinics randomized to UPC. This implementation objective reflects whether the PROUD intervention increases initiation of and/or retention in OUD treatment, documented in EHRs within medical settings. The main secondary objective is to test the hypothesis that PC patients with OUDs documented in their EHRs in the 3 years prior to randomization who receive care in PROUD intervention clinics, compared to those who receive care in UPC clinics, will have fewer days of acute care utilization (including urgent care, emergency department [ED] and hospital care) in the 2 years after randomization. This effectiveness objective assesses whether implementation of the MA Model improves patient outcomes.

NCT ID: NCT03396276 Enrolling by invitation - Opioid Use Disorder Clinical Trials

Houston Emergency Opioid Engagement System

HEROES
Start date: April 1, 2018
Phase: Phase 4
Study type: Interventional

The Houston Emergency Response Opioid Engagement System (HEROES) is a community-based research program integrating assertive outreach, medication-assisted treatment, behavioral counseling, peer recovery support, and paramedic follow-up in Houston Texas. The objective is to compare differences in engagement and retention in treatment for individuals with opioid use disorder.

NCT ID: NCT03394911 Not yet recruiting - Opioid Use Clinical Trials

Healthy Adult Male Facial Skin Surface Lipid Pheromone p.o. to Treat Opioid Addiction

Start date: December 31, 2020
Phase: Phase 3
Study type: Interventional

Healthy adult human male facial skin surface lipid liquid pheromone given by mouth to opioid addicts cures them without any withdrawal symptoms whatsoever 250mg on chewing gum vehicle by mouth. Elevated mood eventually becomes accommodated after a few weeks. The pheromone contains volatile airborne sub-pheromones which cause aversive behavior (distrust, superstition, suspicion, arrogance, astonishment/stupidity, jealousy). Artificial jealousy can be avoided by patient isolation for 40 days until the pheromone "taste" wears off the saliva. The pheromone provided is odorless, colorless, and tasteless to the conscious brain.

NCT ID: NCT03389750 Completed - Opioid Use Disorder Clinical Trials

A Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists.

Start date: March 15, 2018
Phase: Phase 2
Study type: Interventional

Significant public health concerns have arisen from the intravenous misuse of oxymorphone, a potent mu-opioid pain medication. However, little is known about its abuse potential relative to other mu-opioid analgesics. The present study is designed to examine the abuse liability of intravenous oxymorphone compared to other mu opioid agonists (oxycodone, and hydromorphone) among physically dependent opioid abusers.

NCT ID: NCT03377855 Completed - Opioid Use Clinical Trials

Addressing Origins of the Opioid Epidemic by Improving Prescribing for Opioid-Naive Patients

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

Risk of long-term opioid dependence increases with initial opioid dose/duration, but despite recent Centers for Disease Control and Prevention (CDC)-endorsed minimum doses for initial opioid prescription, primary care providers are likely to overprescribe. In this quality improvement project, primary care departments at Weill Cornell and the Institute for Family Health (federally qualified health center in New York City) will implement an unobtrusive "nudge" in their electronic prescribing software to promote the CDC-endorsed low doses for all opioids. In the evaluation, we will employ a quasi-experimental design with rigorous interrupted time series analysis methods to assess the effect of the "nudge" on prescribing rates. The analysis will be performed at the provider level, with deidentified physician data and a limited data set (fully deidentified except for date of prescription) of patient-level data.