Active clinical trials for "Opioid-Related Disorders"

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.

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.

Opioid dependence, for example involving addiction to injected or inhaled heroin or similar compounds, is associated with high mortality, typically from opioid overdose, and causes major physical and mental health complications, social problems and crime. Opioid maintenance treatment (OMT) has proven effective in opioid dependence. In 2014, a patient's choice reform in Skåne county, Sweden, was introduced and led to a vast extension of OMT in the region, including a large number of treatment providers and high access to treatment. Still, opioid-related mortality in the region remains high. While patients' access to treatment has been increased, the content and nature of treatment in the present system has been questioned. The present system, which dramatically altered treatment conditions and access for OMT in this region, has never been formally evaluated in any large-scale study. This study aims to assess clinical course of patients receiving OMT before and during the patient choice reform system, and effects on the extent and nature of opioid-related mortality in the region.

The purpose of this study is to evaluate the use of post-operative opioid use after two different educational interventions. The investigators will compare changes in pain, disability and sleep between groups 6 months after elective lower extremity surgery.

This is a single-center, randomized, open-label, single-dose, parallel-group study which will enroll and randomize approximately 48 subjects (to achieve 36 completers) with opioid use disorder (OUD) who are seeking treatment for OUD. The study includes both a Residential (Inpatient) and Non-Residential (Outpatient) Period.

Purpose: The purpose of this research study is to learn whether oxytocin treatment decreases use of and cravings for opioids (narcotics) in people who have been using opioids heavily for long periods of time and are unable to stop on their own. Participants: Patients meeting DSM-IV-TR criteria for opioid dependence. Procedures (methods): Subjects will have standard medications available for withdrawal symptoms from opioids and standard psychosocial interventions available in the inpatient setting. In addition, subjects will self-administer intranasal test treatments 3 times daily.

Overall, this proposal seeks to improve treatment strategies for the significant public health problem of prescription opioid dependence by determining whether gabapentin, a non-narcotic pharmaceutical agent with minimal abuse potential and preliminary efficacy, will be effective in ameliorating withdrawal symptoms, craving and illicit drug use in prescription opioid dependent participants undergoing a 10-day detoxification from buprenorphine. In addition, the acceptability and feasibility of transitioning to depot naltrexone therapy will also be determined. If successful, this study would provide data to support further development of gabapentin as a pharmacological tool for improved outcomes during opioid detoxification as well as an integrated outpatient approach for treating prescription opioid dependence.

Pregnant women using prescription opioid medication (pain medications) are invited to take part in a program for the reduction of pain and prescription opioid misuse.

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.

The purpose of this project is to assess the impact of an educational video on the use of prescription opioid medication during a 6-month period following spine surgery. Subjects will be recruited from the pool of patients coming in for the pre-operative appointment prior to spine surgery. Patients that consent and enroll will be randomized to receive either a brief educational video at this appointment or usual care. Patients will be followed after surgery weekly for the first month, and then again at 6 months to determine their prescription opioid medication utilization patterns. Prescription data will also be pulled from electronic medical records.