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Opioid-Related Disorders clinical trials

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NCT ID: NCT03427424 Not yet recruiting - Clinical trials for Opioid-Related Disorders

Imaging Biomarker for Addiction Treatment Outcome

Start date: April 25, 2018
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 25 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: NCT03426137 Not yet recruiting - Clinical trials for Opioid-Related Disorders

Relieving Acute Pain From Rib Fractures

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

The United States (US) faces a crisis of pain management. According to the 2012 National Health Interview Survey, almost 50 million adults in the US reported having significant chronic or severe pain (Nahin 2015). Doctors in the US still prescribe opioids across the board for pain despite a growing recognition of an epidemic of opioid overdose and use disorder. Few solutions have been successfully proposed and implemented. Placebos represent a novel and potentially fruitful means of addressing this issue. However, clinicians often use placebos deceptively and with little rationale or evidence of benefit, making their use ethically problematic. In contrast with their typical current use, a provocative line of research suggests that placebos can be intentionally exploited to extend analgesic therapeutic effects. Recently, a database of placebo studies including 22 studies in both animals and humans hints of evidence that placebos may work as a dose extender of active painkillers. Placebos given after repeated administration of active treatments can acquire medication-like effects based on learning mechanisms. Here, the hypothesis that dose-extending placebos are effective in relieving clinical acute pain will be tested in opioid patients with rib fractures. Patients will be randomized to three arms. Arm 1 will be a Full Treatment group, which will receive all NSAIDs as described in the Guidelines for NSAID use in Orthopedic Patient and Oxycodone (10mg tablets). Arm 2 will be a Partial Reinforcement (PR) group, which will receive NSAIDs, Oxycodone (10mg tablets) and placebo pills to reach a 50% reduction of the total intake of opioids. Finally, Arm 3 will be a Control (C) group receiving NSAIDs and placebo pills. Patients will be assigned to one of three arms according to a 1:1:1 schedule of randomization. Randomization codes will be generated by the pharmacy and blinding will be ensured by using capsules for oxycodone and placebo that look identical. Rescue therapy will be provided as needed. This novel prospect of placebo use has the potential to change our general thinking about painkiller treatments, the typical regimens of painkiller applications, and the ways in which treatments are evaluated.

NCT ID: NCT03422211 Recruiting - Postoperative Pain Clinical Trials

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

Opioids
Start date: November 16, 2017
Phase: N/A
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 Enrolling by invitation - Clinical trials for Opioid-Related 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: NCT03394911 Not yet recruiting - Clinical trials for Opioid-Related Disorders

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

Start date: April 2018
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: NCT03377855 Not yet recruiting - Clinical trials for Opioid-Related Disorders

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

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

Risk of long-term opioid dependence increases with initial opioid dose/duration, but despite recent CDC (Centers for Disease Control and Prevention)-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 (NYC-based FQHC) will implement an unobtrusive "nudge" in their electronic prescribing software to promote the CDC (Centers for Disease Control and Prevention)-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.

NCT ID: NCT03320889 Recruiting - Hepatitis C Clinical Trials

Hepatitis C Education for Pregnant Women With Opiate Dependence - Phase 2

Start date: October 30, 2017
Phase: N/A
Study type: Interventional

The goal of this study is to assess patients' attitudes and knowledge of Hepatitis C, analyze the variables that may influence patients' knowledge, and educate patients on Hepatitis C.

NCT ID: NCT03316339 Recruiting - Anesthesia Clinical Trials

Postoperative and Opioid Free Anesthesia

POFA
Start date: November 29, 2017
Phase: Phase 3
Study type: Interventional

Since the 1960's, intraoperative administration of opioids is considered a keystone of anesthesia as well as hypnotics and muscle relaxants. Synthetic opioids were introduced to achieve hemodynamic stability during anesthesia. They allow an inhibition of the sympathetic system without cardiovascular collapse and histamine release. Since then, anesthesia has changed from inhalation to multimodal anesthesia with lower doses of hypnotic. In 2017, the intraoperative objectives of hypnosis, hemodynamic stability, immobility and anticipation of postoperative analgesia can be achieved without opioids. Moreover, opioid administration consequences are neither scarce nor benign for the patient. Perioperative opioids are associated with nausea and vomiting, sedation, ileus, confusion/delirium, respiratory depression, increased postoperative pain and morphine consumption, immunodepression, hyperalgesia and chronic postoperative pain. Among these complications, hypoxemia, ileus and confusion/delirium are the most frequent. Efficacious multimodal analgesia and anesthesia are the basis of successful fast-track surgery. These multidrug regimens aim at decreasing postoperative pain, intra- and postoperative opioid requirements, and subsequently, opioid-related adverse effects and to fasten recovery. Opioid-free postoperative analgesia has been recommended for more than 10 years. Opioid-free anesthesia (OFA) is based on the idea that hemodynamic stability can be achieved without opioids during anesthesia. OFA is multimodal anesthesia associating hypnotics, N-methyl-D-aspartate (NMDA) antagonists, local anesthetics, anti-inflammatory drugs and alpha-2 agonists (Dexmedetomidine). Proofs of the effect of OFA on reducing opioid-related adverse effects after major or intermediate non-cardiac surgery are still scarce. We hypothesized that the reduced opioid consumption during and after surgery allowed by OFA compared with standard of care will be associated with a reduction of postoperative opioid-related adverse events.

NCT ID: NCT03306368 Recruiting - Clinical trials for Opioid-Related Disorders

Youth Opioid Recovery Support: A Developmentally-specific Intervention for Home Delivery of Extended Release Naltrexone

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

Opioid addiction among youth (including both adolescents and young adults) is a growing health problem with catastrophic consequences for young people and their families. The current opioid epidemic disproportionately affects youth. Furthermore, compared to adults, adolescents and young adults tend to have poorer engagement in and response to treatment than older adults. Relapse prevention medications are the clear standard of care for the treatment of opioid addiction in adults, but the evidence base for effectiveness including implementation is not well-established in youth, and concerns from the field emphasize poor adherence and retention. Further there is no consensus regarding models of care, psychosocial treatments and platforms for delivery of medications. Extended release naltrexone (XR-NTX) has proven effectiveness in adults and is a promising pharmacotherapy for youth, but the field needs further clarification of its optimal use and delivery in this target population, in the context of developmentally informed models of care. There is inadequate current capacity for specialty opioid specific treatment that integrates pharmacotherapy (relapse prevention medication) with psychosocial treatment in a context that is youth welcoming and family empowering.

NCT ID: NCT03287180 Not yet recruiting - Clinical trials for Opioid-Related Disorders

Adolescent Community Reinforcement Approach in Combination With Buprenorphine/Naloxone for Severe Opioid Use

A-CRA/MAT
Start date: September 7, 2018
Phase: N/A
Study type: Interventional

The study assesses whether adding a behavioral intervention, known as the Adolescent Community Reinforcement Approach (A-CRA), to the treatment of individuals already receiving buprenorphine/naloxone can improve treatment success and retention rates in young adults with severe opioid use disorder.