View clinical trials related to Opioid-use Disorder.
Filter by:Vietnam is currently decentralizing its methadone maintenance therapy (MMT) dispensing network to its local commune health centers (CHC), which provides a window of opportunity to study decentralization of harm reduction and HIV-related healthcare services into community-based healthcare settings. Commune health workers (CHW) in Vietnam have widespread misconceptions about harm reduction and perceived significant challenges associated with treating people who use drugs. Intervention effort is needed to address these issues to ensure a smooth implementation of the decentralized service model. This study is to pilot testing an intervention with a primary focus on process optimization in six CHC-based MMT distribution sites with 30 CHW and 90 MMT patients. The six CHC in Thai Nguyen Province of Vietnam will be randomized to either an intervention condition or a control condition. The intervention will be executed through a combination of in-person training and mobile phone application utilization. The intervention outcomes on CHW and MMT clients will be evaluated at baseline, 3-, and 6-months.
The overarching goal of the study is to develop, pilot, and evaluate an intervention that aims to retain patients who initiate buprenorphine at Denver Health in ongoing treatment for opioid use disorder.
This project will adapt and pilot a feasible and effective problem-solving therapy designed for low-resource settings to address common mental disorders like depression and anxiety - the Friendship Bench- in a Vietnamese population of individuals living with HIV who also have opiate use disorder. The Friendship Bench approach has the potential to make an important contribution to address CMDs and reduce barriers to HIV treatment success among people living with HIV (PLWH) with Opioid Use Disorder (OUD), a critical population driving the HIV epidemic in Vietnam and many Southeast Asian countries. This proposal will generate critical evidence for designing a fully powered clinical trial to test the investigation team's adapted FB protocol in improving HIV, mental health, and drug use treatment outcomes for this vulnerable population.
This trial is a randomized, double blind, controlled pilot study that will compare bilateral theta burst stimulation (TBS) and sham treatment for patients with opioid use disorder (OUD) and Major Depressive Disorder (MDD) experiencing suicidality.
Most newborns experiencing Neonatal Abstinence Syndrome (NAS) require non-pharmacologic care, which entails, most importantly, maternal involvement with her newborn. To facilitate positive maternal-newborn interactions, mothers need to learn effective caregiving NAS strategies while they are pregnant, yet, an enormous gap exists in the early education of mothers on the symptoms and progression of NAS, in part because no interventions exist to prepare future mothers for the challenges of caring for their newborns at risk for NAS. In this project, the investigators propose to adapt an existing mobile NAS tool for high-risk pregnant women and assess its usability, acceptability, and feasibility in a small randomized controlled analog trial.
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 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.
The proposed study will be a 24-week intervention with a 12-month follow-up period to evaluate the impact of contingency management with stepped care to pre-exposure prophylaxis (PrEP) adherence and support services (CoMPASS) to promote HIV prevention among individuals with opioid use disorder who inject drugs. In parallel, the investigators will conduct an implementation focused process evaluation to inform real-world implementation of CoMPASS. .
ED-initiated buprenorphine with brief intervention and facilitated referral to treatment has been shown to be highly successful in increasing treatment engagement rates and reducing opioid use among adults. It is unknown whether this intervention is similarly effective for adolescents with OUD. To rigorously examine this important clinical research question, it is first necessary to optimize this intervention for the adolescent population. In this R34 proposal, we will use the Assessment-Decision-Administration-Production-Topic Experts-Integration-Training-Testing (ADAPT-ITT) framework-a systematic method for intervention adaptation- to adapt (Aim 1) and test the feasibility (Aim 2) of a treatment strategy for adolescents that has been shown to effectively link adults with OUD to ongoing addiction treatment.