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Drug Overdose clinical trials

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NCT ID: NCT05786222 Enrolling by invitation - Overdose Clinical Trials

Permanent Supportive Housing Overdose Prevention

POP
Start date: September 26, 2023
Phase: N/A
Study type: Interventional

Permanent supportive housing (PSH), the gold standard intervention for ending chronic homelessness, has expanded rapidly across the U.S. in recent years. Due to a confluence of individual and environmental risk factors, PSH tenants face heightened risk for overdose. While evidence-based practices to prevent overdose exist, they have not been broadly implemented in PSH settings. This study will address this research to practice gap by studying the implementation of evidence-based practices to prevent overdose in 20 PSH buildings in New York. In a community-partnered stepped wedge randomized controlled trial, the investigators will study a package of implementation strategies that includes an implementation toolkit, tenant and staff implementation champions, limited practice facilitation, and learning collaboratives. Outcomes will be examined using surveys and qualitative interviews with PSH tenants and staff; observation; and analysis of Medicaid claims data.

NCT ID: NCT05657106 Recruiting - Clinical trials for Opioid-Related Disorders

Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk

Start date: March 6, 2023
Phase: N/A
Study type: Interventional

This study will test the effectiveness, implementation outcomes, and cost effectiveness of a community-tailored, harm reduction kiosk in reducing HIV, hepatitis C, and overdose risk behavior in rural Appalachia. The proposed project will take place in two counties in Appalachian Kentucky, an epicenter for the intertwined national crises of injection drug use, overdoses, and hepatitis C.

NCT ID: NCT05645016 Suspended - Opioid Overdose Clinical Trials

Tailoring Overdose Education for Black Churches

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Church-based interventions are culturally acceptable, reduce access barriers, and can be brought to scale in under-resourced communities. For Overdose Education and Naloxone Distribution (OEND) to be efficacious in Black churches, tailoring may be needed. For this audience, standard OEND curricula may need to be adapted to their level of knowledge of substance use disorders (SUDs), and limited general mental health literacy, and specifically address stigma related to SUDs and medications for opioid use disorder (MOUD). Finally, a tailored implementation strategy may need to address contextual variations (e.g., denomination and membership size) across churches. The proposed pilot study aims to identify the socio-cultural modifications that will be needed to adapt our previously developed training (i.e., COEST) to target Black communities of faith. In a pilot randomized controlled trial (RTC) of adapted COEST in a stepped-wedge design.

NCT ID: NCT05583058 Not yet recruiting - Gender Dysphoria Clinical Trials

Sex Hormone Overdose and Misuse in Chinese Transgender and Gender Non-conforming Population

HODMChina
Start date: December 15, 2022
Phase:
Study type: Observational [Patient Registry]

The investigators propose to investigate the definition of hormone overdose and misuse (HODM) in Chinese transgender and gender nonconforming population (TGNCs), address the incidence of HODM in Chinese TGNC population, related factors and risks, identify the probable causes of HODM, and follow up HODM individuals to explore long-term effects. The research questions are: Q1 What is the definition and the criteria of HODM in Chinese TGNC population? Q2 What is the prevalence of HODM in Chinese TGNC population? Q3 What factors and risks are relevant to HODM? Q4 What are the causes? Q5 What are the long-term effects of HODM in Chinese TGNC population, compared to those who enroll in regular GAHT regimens? The investigators decide to employ a mixed-methods design to construct a full research framework on HODM. A prospective cohort study is a component of the study. The study can be divided into four stages to address research questions. Stage I will establish a precise definition and eligibility criteria of HODM through expert panel meeting and stakeholder engagement. Subsequently, a cross-sectional study will be conducted to evaluate the rate, subtypes, and related factors of HODM in Chinese TGNCs. In Stage III, semi-structured interviews and focus groups for TGNCs who are identified as HODM will be employed to investigate the causes, motivations and personal impact factors. This stage will be divided into two phases, Stage III-a before the cross-sectional study to provide a brief picture of HODM behaviors, and Stage III-b after the cross-sectional study to draw an overall pattern. Lastly, all participants of Stage II or III who would like to participate in our follow-up will be included in prospective cohorts to assess long-term effects. Among the stages, the cohort study is the subject of the registration. The investigators propose two cohorts in the study. Participants who are identified as HODM will be assigned to cohort 1 [HODM cohort], and those who are identified as regular GAHT use will be assigned to cohort 2 [non-HODM cohort]. Participants will be asked to report their gender-related and hormone use-related conditions, and mental health-related conditions at specific timepoints. The investigators will compare the HODM cohort to the non-HODM cohort to see if the overall incidence of adverse effects, gender-related, hormone-related, and mental health-related conditions differ in the cohorts.

NCT ID: NCT05557448 Recruiting - Hepatitis Clinical Trials

To Evaluate the Efficacy and Safety of TYNADOTE® in the Treatment of Acetaminophen Overdose

Start date: May 1, 2023
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy and safety of TYNADOTE® in the treatment of acetaminophen overdose

NCT ID: NCT05518461 Completed - COVID-19 Clinical Trials

Smartphone Intervention for Overdose and COVID-19

Start date: December 19, 2022
Phase: N/A
Study type: Interventional

This study will examine if the use of a smartphone application called Thrive4Life Connect can help people who use drugs lower their risk of overdose and learn more about COVID-19 vaccines. 60 participants will be enrolled and can expect to be on study for up to 6 months.

NCT ID: NCT05517668 Recruiting - Liver Failure Clinical Trials

Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose

Start date: September 12, 2022
Phase: Phase 2
Study type: Interventional

This study is a randomized, placebo-controlled double-blinded clinical trial of patients presenting with acetaminophen poisoning who are at increased risk of developing liver injury. With this trial the investigators are hoping to show the superiority of acetylcysteine (NAC) + fomepizole (4-MP) compared to treatment with acetylcysteine alone. The primary objective of this trial is to determine the effect of fomepizole on the severity of acute liver injury in patients with acetaminophen poisoning.

NCT ID: NCT05493475 Recruiting - Harm Reduction Clinical Trials

Evaluation of a Novel Intervention to Prevent Polysubstance Overdoses Involving Illicit Stimulants

Start date: November 10, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to investigate the feasibility, acceptability, and associated benefits and harms of integrating FTS education and distribution into select courts in rural and urban communities in Ohio.

NCT ID: NCT05463341 Recruiting - Harm Reduction Clinical Trials

Evaluating an Intervention to Prevent Overdoses in Rural and Urban Counties

Start date: September 9, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to investigate the feasibility, acceptability, and associated benefits and harms of integrating FTS education and distribution into select Project DAWN sites in rural and urban communities in Ohio.

NCT ID: NCT05377255 Completed - Opioid Overdose Clinical Trials

Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults

Start date: March 28, 2022
Phase: Phase 1
Study type: Interventional

This study will be a Phase 1, single-center, open-label, randomized cross-over study to evaluate the PK of a new AP003 device which delivers two sprays of 4 mg naloxone hydrochloride intranasally.