View clinical trials related to Opioid-Related Disorders.
Filter by: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 majority of opioid users meet criteria for anxiety and depressive disorders, but most substance use disorder treatment programs do not offer treatment for co-occurring mental health problems. Anxiety and depression may also be directly linked to opioid use itself. Although treatments have been developed for anxiety and depressive symptoms for opioid users within face-to-face settings, few treatment facilities offer these in-person interventions due to their high cost and time burden. Given the deficits in research on treatments for anxiety and depression among those with opioid use disorder, the current research will examine the efficacy of a digital intervention designed to treat anxiety and depressive symptoms by augmenting the state of the science medication-based opioid use disorder treatment. Over the course of the proposed study, the research team will design and test the feasibility and acceptability of a standalone mobile intervention designed to treat persons receiving medication treatment for opioid use disorder. Participants receiving medication treatment for opioid use disorder will be randomized to receive a digital intervention to treat anxiety and depression or care as usual for a total of four weeks. The overarching goal of the proposed work is to test the feasibility and acceptability of the proposed mobile intervention. The Investigators will also explore the preliminary efficacy by examining reductions in anxiety and depressive symptoms and opioid cravings and use. This work could lead to a low-cost scalable solution to augment gold-standard treatment as usual in opioid use disorder by decreasing levels of comorbidity of anxiety and depressive disorders, thereby ultimately improving the outcomes of opioid use disorder itself.
This is a Phase 1 trial that aims to establish the safety of MORE-VR, as well as to collect feasibility, usability, and engagement data, for patients receiving medications for opioid use disorder (mOUD).
The purpose of this study is to determine the impact of cannabidiol on reward- and stress-related neurocognitive processes among individuals with opioid use disorder on buprenorphine or methadone treatment.
French translation and validation of the Prescription Opioid Misuse Index scale (POMI), a brief questionnaire to assess opioid prescription misuse. In view of the increase in the prescription of opioid analgesics for chronic non-cancer pain (CNCP), this tool is particularly interesting to use during medical consultations to screen misuse in opioids user patients. We conducted an observational, prospective and multicenter psychometric study with a cross-cultural validation in 154 CNCP patients treated by opioid at least from 3 months, in two pain clinics.
The primary objectives for the study are: - Part I and Part II: Assess safety and tolerability of repeated doses of INDV-2000 in healthy volunteers. - Part III: Assess the safety and tolerability of repeated doses of INDV-2000 administered alone and with SUBOXONE sublingual (SL) film in an opioid use disorder (OUD) treatment seeking population.
This is a formative research study to test a culturally-centered, program-level implementation intervention to increase the use of medications for opioid use disorder in four healthcare and addiction specialty treatment sites serving American Indian and Alaska Native communities.
This is an open-label, randomized, parallel-group multicenter study designed to evaluate the efficacy of the digital therapeutic OXD01 (MODIA) combined with sublingual buprenorphine/naloxone standard of care (SL BUP/NAL SOC) background therapy compared to SL BUP/NAL alone to change opioid use patterns in subjects with OUD. Approximately 400 subjects will be randomized. The study will include a screening visit and a randomization visit, followed by 24 weeks of study treatment. Subjects will be scheduled for evaluation visits, which will include a UDS and a self report of drug use, weekly during the first four weeks of treatment, then every other week from weeks 5 through 12, then monthly through week 25. Subjects will also return to the site for only a urine drug screen (UDS) and a self-report of drug use each week between the evaluation visits. The primary objective of the study is to determine whether the combination of sublingual (SL) buprenorphine/naloxone (BUP/NAL) standard of care (SOC) background therapy and the digital therapeutic OXD01 is superior to SL BUP/NAL alone to reduce opioid use.
This study integrates the Mental Health Research Network (MHRN) suicide risk models into Opioid Wizard, an electronic health record (EHR) clinical decision support (CDS) to identify and treat patients at high risk of opioid use disorder (OUD)/overdose or diagnosed with OUD, to alert primary care clinicians (PCCs) to patients at elevated risk for suicide and guide them through structured suicide risk assessment. In both intervention and control clinics, suicide risk scores will be calculated for all Opioid Wizard-eligible patients and relevant EHR data to inform analyses will be archived. In intervention clinics, Opioid Wizard will alert PCCs to Opioid Wizard-eligible patients who are at increased risk of suicide and coach them through use of the Columbia Suicide Severity Risk Scale (CSSRS), a structured tool in the EHR that will help PCCs assess immediate suicide risk. Based on the resulting CSSRS score, Opioid Wizard will provide EHR links for risk-based referrals and follow-up recommendations, including care as usual, routine or emergent referral to behavioral health, or transportation to the emergency department (ED) for further assessment. Primary outcome measures include completion of CSSRS assessments for at-risk patients and patient engagement in outpatient mental health care.
The primary objectives of this study are to evaluate the safety and tolerability of KNX100 administered orally as a single and multiple ascending doses in healthy volunteers.