View clinical trials related to Opioid-use Disorder.
Filter by:Even when treated with methadone or buprenorphine maintenance, many people with opioid use disorder (OUD) continue to experience craving. Among both users of heroin and users of prescription opioids, mounting evidence shows that craving predicts return to use and undermines existing treatments for OUD, thus, the development of new interventions to reduce craving is a priority for addressing the opioid crisis (NIH HEAL Initiative Research Plan, 2019). Deficits in executive functioning, particularly working memory, are a central mechanism that undermines the ability to inhibit craving. Laboratory studies in non-clinical samples show that engaging in working memory tasks before or during a craving induction increases the ability to resist craving. This suggests that people with OUD may benefit from engaging in working memory tasks at the specific moment when craving occurs. Although previous research shows that working memory "training" does not improve clinical outcomes in OUD, these studies have not delivered training at the moment that craving actually occurs in daily life. Thus, engaging in working memory tasks at the moment that craving occurs could presumably help individuals with OUD to manage this persistent symptom, but this has not been tested. Further, studies using Ecological Momentary Assessment (EMA) methods show that people with OUD can accurately track moment-to-moment fluctuations in craving in their daily lives, suggesting that it may be feasible to deliver interventions for craving in the moment when craving is reported. This study will test the efficacy of embedding a mobile cognitive intervention into an EMA design in people with OUD. Using the NIH Stage Model of Intervention Development, Stage 1A of this project will optimize a working memory intervention based on iterative feedback from a sample of people with OUD (n = 20), in preparation for a Stage 1B trial using a randomized design. In this trial, participants with OUDs (n = 60) will complete a two-week EMA study in which they complete smartphone-based assessments of craving five times daily. When craving is reported, a mobile application containing the working memory intervention will activate. Half of the participants will complete the intervention, while half will complete a control task. At the conclusion of the trial, participants will be granted unrestricted access to the intervention during a feasibility phase. Outcomes include change in momentary craving, change in working memory performance, and feasibility and acceptability, including use of the intervention during follow-up. Substance use will also be assessed. This project supports the applicant's goal of leveraging cognitive mechanisms to conduct treatment development research for OUD. The applicant will receive training in the etiology and treatment of OUD, craving, mobile intervention development and human-centered design of interventions, and analysis of intensive longitudinal data. With its emphasis on modifying cognitive processes at the moment of craving, using mobile devices in patients' daily lives, this project has the potential to reveal new pathways for addressing a significant predictor of relapse in OUD.
This study is a multi-site, randomized pragmatic trial being conducted at three diverse sites. The study, called the Substance Use Treatment and Recovery Team (START), will evaluate whether a collaborative care team increases the use of two interventions-medication for opioid use disorder (MOUD), and opioid use disorder (OUD) focused discharge planning-among hospitalized patients with OUD, and improves linkage to follow-up care relative to usual care. The START consists of an addiction medicine specialist and a care manager who will use evidence-based tools to decrease barriers to MOUD and engage patients with post-discharge OUD care. A total of 414 patients will be randomized from Cedars-Sinai Medical Center in Los Angeles, the University of New Mexico Hospital in Albuquerque, and Baystate Health in Springfield, Massachusetts to receive either START or usual care, stratifying by prior MOUD exposure and site.
The goal of this project is to engage community members from two low-income African American communities (N=200) in a survey study that assesses stigma toward those with Opioid Use Disorder (OUD). Those from the intervention community will be subject to a stigma reduction campaign via billboards. Those from the control community will not. Stigma will be re-assessed following the period of the campaign.
The purpose of this research study is to test the effect of repetitive transcranial magnetic stimulation (rTMS) on opioid cravings among adult patients with Opioid Use Disorder.
In this pilot single-armed open-label intervention study of up to 20 individuals with moderate to severe Opioid Use Disorder (OUD)organized into two consecutive groups of up to 10 individuals each, the investigators will measure addiction outcomes and the acceptability and feasibility of adding Mindfulness Oriented Recovery Enhancement (MORE), a promising mind-body therapy to gold standard in-hospital addiction consultation among hospitalized individuals with OUD in advance of a planned two-arm pilot randomized controlled trial.
This is a phase IIa, randomized, placebo-controlled pilot study designed to examine whether low-dose cariprazine (1.5mg/d) impacts cocaine use in medically-stable OUD patients with co-occurring CocUD who have already been taking BUP-NX at a stable dose for at least one week (up to 24mg buprenorphine/6mg naloxone daily). To be eligible for this relapse-prevention study, patients will have a cocaine-negative urine at the time of study enrollment. Approximately 48 subjects will be randomized to participate in this study. At randomization, patients will be stratified on cocaine-use severity, e.g., < 8 days cocaine use in the prior month (less severe) vs. > 8 days cocaine use in the prior month (more severe). A subset (n=24) of participants who are fMRI-eligible will also participate in an fMRI session during the trial, examining whether cariprazine impacts the brain response to relapse-relevant probes of reward and inhibition. All fMRI-eligible patients will be offered the scanning opportunity, until 24 scans are acquired. Blinding: This pilot study will be designated as single-blind. Participants are blind to their medication status. In our single-blind studies, we also ask our clinical / patient-interacting staff to remain "blind" to the participants' medication status (similar to 'double-blind' studies), but our non-treatment (e.g., engineering) staff have access to participant group status for preliminary data examinations. After enrollment, subjects will be randomized to receive 1.5mg/d cariprazine or placebo in a 2:1 ratio. At baseline, subjects will complete several assessments, behavioral tasks and neurocognition probes monitored by fNIRS and will then begin taking cariprazine (or placebo) each day for 8 weeks. The behavioral tasks and fNIRS session will be collected again 10-17 days after taking the first dose of study medication, when plasma levels of cariprazine are likely approaching steady-state; fMRI probes will be collected at the steady-state timepoint in the fMRI-eligible subgroup. Urines will be collected 2x/weekly throughout the trial; weekly blood samples will be analyzed for buprenorphine/norbuprenorphine as an index of BUP-NX compliance, and for metabolites of cariprazine, for cariprazine compliance. Individuals will participate for approximately 11 weeks, inclusive of the screening period and follow-up visit; maximal study medication exposure for each subject is up to 8 weeks. The study has 4 distinct phases: 1. Screening (approx. 1-2 weeks) 2. Baseline (1-2 visits; includes baseline assessments, behavioral tasks/fNIRS session, and randomization) 3. Outpatient treatment (8 wks; 2 visits/wk, includes daily cariprazine (or placebo), daily BUP-NX (at the participants' usual community treatment site), and imaging (fMRI and fNIRS)/behavioral tasks at steady-state. 4. Follow-up: A follow-up visit to assess medical and psychological status will occur approximately 1 week after the last dose of study medication.
The purpose of this study is to evaluate the efficacy; safety and tolerability of ASP8062 compared with placebo ASP8062 as add-on therapy to buprenorphine/naloxone.
In this randomized, double-blind, controlled, parallel group study (conducted over 12-months), enrollment is expected of up to 60 subjects (30 men and 30 women) ages 18+ who are currently going through withdrawal of OUD and being treated at local substance abuse clinics. The study visits will include screening, baseline, Weeks 1, 2, 3, and 4, with both safety and efficacy assessments.
The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone during Phase II.
Severe chronic pain and opioid use disorder (OUD) occur at significantly higher rates in Veterans compared to the general population. Chronic pain often persists despite engagement in opioid agonist treatment (OAT), the first line treatment for OUD. Recent VA guidelines strongly recommend non-pharmacologic treatment for chronic pain, but individuals with OUD are frequently excluded from pain treatment studies. There is a need for evidence-based pain treatments that compliment OAT for Veterans with chronic pain and OUD. In this study, the investigators will determine feasibility and acceptability for a behaviorally focused pain treatment that includes pain education and a pedometer assisted adaptive walking program for Veterans receiving OAT for OUD. Potential treatment outcomes will be repeatedly assessed using a mobile device, and study-provided pedometers. By offering pain treatment within OAT clinical care, the investigators hope to decrease stigma and increase access for Veterans with chronic pain and OUD.