View clinical trials related to Opioid-Related Disorders.
Filter by:This study compares two methods of initiating treatment with extended-release naltrexone (XR-NTX) when implemented at community-based inpatient or residential programs. The primary goal of this hybrid effectiveness-implementation study is to determine whether the Rapid Method (5-7 day long) is non-inferior to a Standard Method (13-day long) on the primary effectiveness outcome of successful initiation of XR-NTX (receiving the first injection). Secondary objectives include comparing Rapid versus Standard method on: time from admission to first dose of XR-NTX and time to dropout, craving, withdrawal severity, retention, abstinence, and safety measures, as measured during the inpatient induction process and the first two months of post-induction XR-NTX maintenance. Other exploratory outcomes include predictors of initiation success, and economic analyses. The implementation goal is to operationalize an implementation facilitation strategy that will be used to train clinical sites on the XR-NTX initiation method, to capture fidelity to the rapid induction process, and to study barriers and facilitators to implementation and refine the implementation facilitation strategy accordingly.
Opioid misuse is a national public health epidemic. More than 130 people in the United States die each day following an opioid overdose, and over 2 million people meet criteria for an opioid use disorder (OUD). Medication-assisted treatment (MAT), which involves use of medication (buprenorphine, methadone, naltrexone) in combination with behavioral therapy or counseling, is the most effective intervention for OUD. Yet, MAT remains less than optimally effective, particularly for patients with psychiatric comorbidity [6]. Novel approaches are needed to improve long-term outcomes for OUD patients. Psychological trauma and posttraumatic stress disorder (PTSD) are highly prevalent among individuals with OUD. Over 90% of adults with OUD report a lifetime history of trauma. Among OUD patients engaged in MAT, nearly 20% report experiencing at least one new traumatic event each month, and nearly a third meet criteria for a co-occurring diagnosis of posttraumatic stress disorder (PTSD). Several studies have linked new incidents of trauma as well as the presence of PTSD to poorer MAT engagement and poorer treatment outcomes, including treatment interruption and premature dropout. Preliminary evidence suggests that engaging in trauma-focused treatment for PTSD concurrent with MAT may result in better long-term adherence to medication for OUD. However, recent evidence finds that fewer than half of patients with PTSD in MAT receive any trauma-focused treatment, and even fewer receive evidence-based interventions. Trauma-focused treatments that concurrently address symptoms of PTSD and substance abuse using an integrated approach have been recommended over traditional substance abuse interventions for patients with this complex dual diagnosis presentation. Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE) is a 12-session evidence-based cognitive-behavioral therapy that integrates exposure therapy for PTSD with cognitive-behavioral skills for addressing problem substance use. COPE has demonstrated efficacy for reducing symptoms of PTSD and substance use disorder across multiple trials. Most samples have included patients with alcohol use disorder or mixed substance use disorder diagnoses. The proposed pilot study would collect preliminary feasibility data to support the first trial of COPE for patients with OUD (and other substance use disorders) who are currently engaged in MAT. As such, a primary aim of the current pilot is to obtain patient feedback regarding the acceptability and applicability of COPE for patients with PTSD receiving MAT treatment through the Supportive Medication Assisted Recovery Treatment (SMART) Program within the University of Kentucky (UK) Department of Psychiatry, an outpatient buprenorphine clinic. The investigators believe that it is critical to engage patients directly in the process of intervention development/refinement to determine how an existing evidence-based intervention like COPE might be modified to best fit the unique needs of patients receiving MAT.
The opioid epidemic is the largest man-made public health crisis the United States has faced. The objective of Trial 2 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-2) study, is to discourage unnecessary opioid prescribing by increasing the salience of negative patient outcomes associated with opioid use.
This is a Phase I, single-center, single arm, open-label study, to establish the pharmacokinetic (PK) parameters of Vivitrol 380 mg IM injection (IP), a US Food and Drug Administration (FDA) approved medication.
pills go unused, generating waste and leaving an opportunity for misuse and abuse. In a recent study, researchers let patients choose what medications to go home with after surgery. After their thyroid or parathyroid surgery, 96% of patients declined narcotic pain medication. They preferred to manage their pain with acetaminophen instead. Giving patients counseling and empowering them to choose significantly reduces the amount of opioids prescribed and wasted. The aim of our study is to compare a similar "opt-in" protocol for narcotics to usual care (where patients are routinely discharged with opioids). We would elaborate upon the aforementioned study by studying patient pain scores on a more granular level once they return home. Our study will be designed as a randomized, controlled trial. When adult patients consent for a thyroid or parathyroid surgery, they will be asked to participate in the study. Patients who are currently using narcotics would be excluded. We would then randomize participants to the "opt-in" protocol versus being provided with a standard opioid prescription after surgery. Patients in the opt-in protocol will be recommended a pain treatment regimen with over-the-counter medications, such as acetaminophen or ibuprofen. These patients will be reassured that if their pain is uncontrolled after discharge, a narcotic prescription will be called in to their pharmacy if requested. We will assess patient pain scores and medication use in the recovery area using the electronic medical record. We will collect data on patient pain scores and medication use after discharge on a daily basis via phone call or electronically transmitted survey. We will also evaluate patients at the time of their follow-up visits. Any patient phone calls will be routed to study personnel who will fill narcotic prescription requests if requested. Finally, among patients who do receive an opioid prescription, we will track their opioid consumption.
The goal of this project is to develop a multicomponent stigma reduction intervention to address intrapersonal (individual) stigma regarding Opioid Use Disorder (OUD). The intervention will address this cost/benefit evaluation among individuals known to face intersecting stigma of OUD and African American race, with treatment elements chosen explicitly to increase the value of treatment using salient forms of reward, and to ease perceived costs through explicit services in an effort to encourage the occurrence of the first treatment visit for OUD.
Is there any difference in the intensity of postoperative pain, nausea, urinary retention and legth of hospital stay in patients undergoing robotic assisted laparoscopic surgery if they receive intrathecal morphine or peroral and intravenous opiates during the surgery and is there a significant difference in the need of opiates after the surgery.
A randomized pilot study assessing feasibility, acceptability, and preliminary effectiveness of a reward-based recovery management platform (PROCare) designed to enhance participation in outcomes monitoring, engagement in treatment care, and adherence to medication for opioid use disorder.
The investigators will conduct a phase I study involving 41 participants selected randomly among patients prescribed buprenorphine-naloxone for opioid misuse as a feasibility trial of the study of the Pillsy device. The study will track the effectiveness of the Pillsy technology and associated smartphone application by measuring adherence to buprenorphine-naloxone therapy and patient satisfaction with the application and the Pillsy device.
The majority of men experiencing opioid use disorder and receiving treatment are fathers. Substance use, transitions between in-patient and out-patient treatment, and reunification as a family, all create considerable strain and are predictive of a host of negative long-term outcomes including increased rates of relapse for fathers and elevated risk for behavioral, emotional, and substance use problems in their children. Evidence-based parenting interventions for fathers are lacking in general, yet are exceedingly rare for fathers participating in opioid use disorder treatment, even though the extant research literature suggests the integration of services is not only timely but may help engage and retain fathers in treatment and produce protective factors for children. The goal of this project is to develop and evaluate a prototype of a usable innovative web-based program that integrates existing evidence-based parenting programs, yet tailored specifically to fathers with opioid use disorder and designed for the opioid treatment context in order to promote the implementation and dissemination of father specific empirically-supported treatment.