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Opioid-Related Disorders clinical trials

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NCT ID: NCT04499079 Enrolling by invitation - Clinical trials for Substance-Related Disorders

Alliances to Disseminate Addiction Prevention and Treatment (ADAPT)

ADAPT
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Youth involved in the juvenile justice system (YJJ) bear a disproportionate burden of the addiction crisis. YJJ substance use (SU) is extremely prevalent, with a third of YJJ meeting criteria for a substance use disorder (SUD). The investigators seek to address the national addiction crisis at its epicenter. Despite their high need for SUD services, and the proliferation of evidence-based interventions to reduce SU, YJJ are rarely connected to needed, high-quality SU care. A care cascade model highlights gaps in YJJ achieving the full continuum of SUD care (i.e., SUD risk identification, treatment referral, treatment initiation, and treatment engagement). YJJ on community supervision/probation face a unique problem accessing SUD services; while the courts or probation may identify YJJ need for SUD care, YJJ must receive care through healthcare agencies in the community. The primary goal of the project, Alliances to Disseminate Addiction Prevention and Treatment (ADAPT) is to address this and other gaps along the care cascade for YJJ. The investigators will accomplish this goal by creating alliances between the juvenile justice system (JJ) agencies and community mental health centers (CMHCs) in eight Indiana counties. ADAPT takes a two-pronged approach. First, the investigators will employ a Learning Health System (LHS) to develop collaborative alliances between JJ agencies and CMHCs, organizations that traditionally operate independently. Second, the investigators will present local Cascade data during continuous quality improvement cycles within the LHS alliances. By offering agency representatives an opportunity to view and discuss, for example, the local rate at which YJJ with SUD risk are initiating CMHC SU services, the investigators will facilitate development of tailored, local solutions to improve the Cascade for each county's YJJ. To maximize long-term sustainability of ADAPT's JJ-CMHC alliances, the investigators will conduct this research in collaboration with leaders from an existing statewide initiative, the Juvenile Detention Alternatives Initiative (JDAI). JDAI is a juvenile justice reform effort that utilizes data-driven decision-making and is implemented in almost 300 counties across the US. If this project is successful, the JDAI infrastructure and support for this research will inform sustainment and expansion across Indiana and the nation. The investigators hypothesize that ADAPT - novel LHS alliances using Cascade data to implement localized solutions to YJJ receiving evidence-based addictions care - will positively impact SU and recidivism outcomes over time. The investigators seek to complete the following specific aims: AIM 1: Implement LHS alliances between JJ agencies and CMHCs. The investigators will establish LHS alliances: novel, collaborative partnerships between JJ agencies and CMHCs. AIM 2: Generate and track local solutions to address gaps in the Cascade for YJJ in rural Indiana counties. Quantifying local Cascade data will enable JJ agencies and CMHCs to suggest and implement tailored, evidenced-based interventions, which will be tracked through LHS quality improvement cycles. AIM 3: Assess implementation outcomes and processes. We will assess implementation outcomes, such as system alliance, among JJ and CHMC personnel using mixed methods. AIM 4: Assess the impact of ADAPT. Conduct a stepped wedge cluster randomized controlled trial to assess the impact of LHS alliances on the Cascade for YJJ. We will analyze administrative data linked across JJ and health systems to assess the long-term, community-wide effects of ADAPT on public health and safety outcomes (e.g., lower rates of SU-related outcomes and criminal recidivism).

NCT ID: NCT04496934 Completed - Clinical trials for Substance Use Disorders

Physical Activity as Adjunct Treatment for Opioid Substitution Therapy

Start date: January 30, 2018
Phase: N/A
Study type: Interventional

In terms of research, it is documented that exercise has a positive effect on mental disorders. Studies have shown positive correlations between physical and mental health, also among substance users. Such a study has never been performed on patients in opioid substitution therapy (OST). Documentation on the physical health of patients and the effect of exercise is very limited. Treatment of substance users is a research area with insufficient knowledge about certain treatment effects. It is important that a treatment can both support and promote the user's own resources and efforts to change their habits of substance use. The objective of this project is to examine the effect of exercise for OST patients, measured in relation to cognitive function and physical form. The target group consists of OST patients from 18 years of age and up, of both sexes, and on stable medication. At least 60 participants should complete the project, which is designed as a controlled randomized study (RCT). Participants in the intervention group start to exercise immediately after baseline testing. Participants in the control group are on a waiting list and will start to exercise after twelve weeks. Both groups undergo testing at baseline, after three, six and 12 months. Testing consists of two parts: A battery of cognitive and psychosocial assessments and an assessment of physical variables. The research questions of this project are important in a public health perspective. Generated knowledge can be quickly applied to local treatment institutions in Norway.

NCT ID: NCT04495673 Completed - Clinical trials for Opioid-Related Disorders

Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder

Start date: January 11, 2021
Phase: N/A
Study type: Interventional

The overarching goal of this project is to expand the traditional expertise in non-invasive neuromodulation at the University of Minnesota towards developing novel paired-neuromodulation approaches using transcrancial direct current stimulation (tDCS) for new addiction treatments that support long-term abstinence. This study will investigate whether the pairing of dorsolateral prefrontal cortex (DLPFC) stimulation and cognitive training can enhance functional connectivity between DLPFC and nucleus accumbens (NAcc). We have identified higher functional connectivity between DLPFC and NAcc in alcoholics that have successfully maintained abstinence for extended periods of time (7 years). This paired-neuromodulation approach can potentially be used as a therapeutic intervention to decrease substance use probability in addiction (e.g. opioid use disorder). The long term goal is to develop new addiction treatments that support long-term abstinence in opioid use disorder. The overall objective of this proposal is to enhance functional connectivity between DLPFC and NAcc as a therapeutic intervention to enhance cognition and reduce substance use rates in opioid use disorder.

NCT ID: NCT04495374 Terminated - Pain, Postoperative Clinical Trials

Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy

Start date: September 2, 2019
Phase: Phase 4
Study type: Interventional

Postoperative pain affects 80% of surgical patients and is one of the main negative symptoms resulting from surgery. It impairs the recovery of patient since it is related to chronic pain, nausea and vomiting and longer hospital stay, generating higher cost to the health system. Thus, the use of new methods to control postoperative pain is recommended and multimodal analgesia, an opioid-sparing strategies, has been widely used by several researchers. Studies show that gabapentins have beneficial effects on postoperative pain control when used as pre-anesthetic medication, also showing a reduction in opioid consumption, with few adverse effects. Among gynecological surgeries, abdominal hysterectomy is one of the procedures that generates the highest degree of acute postoperative pain. Thus, the aim of the present study is to investigate the effect of oral pregabalin (300 mg) two hours before abdominal hysterectomy procedures on postoperative pain. This study is a randomized, double-blind, placebo controlled clinical trial. Patients submitted to abdominal hysterectomy for benign pathologies will be selected and divided into two groups: the placebo controlled group (P0) and the pregabalin 300 mg group (P1). Group P0 will receive a placebo tablet one hour before the procedure, while group P1 will receive a 300 mg tablet of pregabalin identical to the placebo tablet. The reduction of postoperative pain and the best quality of patient recovery will be evaluated using the Visual Analogue Pain Scale (VAS) and the McGill Pain Questionnaire. Also, it will be evaluated the consumption of opioids as a rescue analgesic medication and the presence of adverse effects such as nausea and vomiting.

NCT ID: NCT04494698 Active, not recruiting - Opioid Use Clinical Trials

Impact of DuoTherm on Opioid Use and Chronic Low Back Pain

Start date: June 23, 2022
Phase: N/A
Study type: Interventional

Evaluate opioid use and pain change in chronic Low Back Pain with DuoTherm Compared to Active Control

NCT ID: NCT04480554 Recruiting - Inflammation Clinical Trials

Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1

AMOHI-1
Start date: January 30, 2023
Phase: Phase 2
Study type: Interventional

HIV infection, as well as exposure to opioids (including heroin), are associated with systemic immune activation including increased microbial translocation from the gut. The overall objective of this study is to define the impact of long-term mu-opiate receptor stimulation or blockage with medication for opiate use disorder (i.e, methadone, buprenorphine/naloxone, or extended-release naltrexone) on the kinetics and extent of immune reconstitution on HIV-1 infected people who inject opiate and initiating antiretroviral therapy.

NCT ID: NCT04479475 Recruiting - HIV Infections Clinical Trials

Social Networks and Methadone Maintenance Treatment Retention and Antiretroviral Therapy Retention in Tanzania

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Investigators will adapt the Brief Social Behaviour and Network Therapy (B-SBNT) intervention developed to facilitate recovery among people receiving medication-assisted treatment for opioid use disorder in the United Kingdom. The B-SBNT involves families and the wider social networks of people receiving medications for opioid use disorder to support recovery. Key components of the intervention include: mapping the social networks of clients; inviting others identified through the mapping to participate in the intervention; building communication strategies with network members; and developing joint activities with network members. In the original B-SBNT, the intervention is delivered by therapists/clinicians who undergo training. Investigators will pilot test the adapted version of this intervention with a maximum of 80 people: 20 current clients receiving methadone maintenance treatment (MMT) at the Muhimbili National Hospital (MNH) Medically-Assisted Treatment (MAT) Clinic and up to 60 social support persons identified by recruited MMT clients. The pilot will assess the social network intervention's acceptability and feasibility.

NCT ID: NCT04477304 Completed - Clinical trials for Opioid Abuse, Unspecified

Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 1: EHR Nudges

AESOPS-T1
Start date: December 1, 2020
Phase: N/A
Study type: Interventional

The opioid epidemic has had a tremendous negative impact on the health of persons in the U.S. The objective of the trial 1 of Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-T1), is to discourage unnecessary opioid prescribing through the application of "behavioral insights"-empirically-tested social and psychological interventions that affect choice.

NCT ID: NCT04473950 Terminated - Opioid-use Disorder Clinical Trials

The Effect of Chronic Pain on Delay Discounting in Methadone Patients

Start date: January 8, 2020
Phase: Phase 1
Study type: Interventional

The epidemic of opioid overdose deaths continues to rise, killing more persons in 2017 than HIV/AIDS at the height of that epidemic. Medication assisted treatment, including methadone and buprenorphine, is the standard of care for the treatment of opioid use disorder (OUD). However, chronic pain can reduce treatment efficacy during medication assisted treatment and is associated with illicit substance relapse, dropout, and subsequent overdose. Mechanisms by which chronic pain may influence the impulsive decision making (e.g., drug relapse) in persons with OUD have not been well characterized. A better understanding is needed of decision-making in this population. Two factors that can influence decisions to use drugs are impulsivity and acute opioid withdrawal. This proposal will test how chronic pain is associated with increases in impulsive decision making in OUD, whether impulsive decision making is greater when undergoing opioid withdrawal, and how catastrophizing may modify the association between withdrawal and impulsive decision making in patients with chronic pain and OUD. An ideal population for this developmental research project are methadone maintained patients, who show high treatment attendance rates and will therefore assure study efficiency and reliable completion.

NCT ID: NCT04464980 Recruiting - Clinical trials for Opioid Use Disorder (OUD)

Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)

Start date: June 8, 2021
Phase: Phase 2
Study type: Interventional

This is a two phase study investigating combinations of pharmacological and behavioral interventions to optimize the treatment of Opioid Use Disorder (OUD). The Retention Phase will assess strategies for improving retention on buprenorphine (BUP) and extended-release injectable naltrexone (XR-NTX). The Discontinuation Phase will assess which approaches are most likely to lead to long-term success (absence of relapse), and what characteristics of participants distinguish those who can safely discontinue Medications for Opioid Use Disorder (MOUD) from those who remain at risk of relapse and should not discontinue.