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Harm Reduction clinical trials

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NCT ID: NCT05404815 Active, not recruiting - Preterm Birth Clinical Trials

Exposure to Plasticisers in the Neonatal Intensive Care Unit

PLASTIC-NICU
Start date: June 2, 2020
Phase:
Study type: Observational

Neonatal intensive care relies on indwelling plastic medical devices fundamental in respiratory support, intravenous catheterization, and nutrition. While being in a critical developmental period, constant exposure to these invasive medical devices puts premature neonates at risk of plasticizers' potential toxicity. Despite novel regulations and development of alternative plasticizers (AP), reference to guide manufacturers and an overview of the prevailing exposure levels to DEHP or alternatives in the neonatal intensive care unit (NICU) are still missing. The three main objectives of this project are: (1) to assess current exposure to plasticizers in the NICU, (2) to identify the sources of exposure and (3) to study the resultant long-term health risk in premature neonates. These objectives are addressed in three work packages (WP). In work package 1, in vivo exposure of premature neonates to phthalates and alternative plasticizers is assessed by determining their metabolites in biological matrices (urine and hair). Work package 2 explores ex vivo leaching characteristics of different plasticizers from medical devices used in the NICU. Finally, Work package 3 studies the long-term neurocognitive and lung development in relation to plasticizer exposure in the NICU.

NCT ID: NCT04700930 Active, not recruiting - Harm Reduction Clinical Trials

CBD Cigarettes Instead of Normal Cigarettes as Innovative Treatment for Schizophrenia

Start date: October 4, 2018
Phase: N/A
Study type: Interventional

Interventional study using Cannabidiol containing cigarettes as replacement of usual cigarettes Reduction of enforcement measures, improved acute treatment, harm reduction, and improvement of psychotic symptoms

NCT ID: NCT04650269 Completed - HIV Infections Clinical Trials

Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program

Start date: March 4, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to see if providing HIV medicine right away at the IDEA Syringe Services Program will help the participant start and remain in HIV care, including having no detectable HIV in the participant's blood.

NCT ID: NCT04351958 Not yet recruiting - Harm Reduction Clinical Trials

An Augmented Reality Videogame for Alcohol Use Prevention and Harm Reduction in Teens

Start date: June 2024
Phase: N/A
Study type: Interventional

The goal of this research study is to develop the AR-based alcohol use prevention and harm reduction intervention, "No Time Wasted", with the further aim of conducting a pre-post pilot study to assess whether the game reduce risk behaviors associated with alcohol use, whilst also increasing knowledge about some of the following topics: BAC, standard drink sizes, signs of alcohol poisoning. The intervention will also seek to encourage bystander intervention to assist fictional characters in need of help due to overdrinking.

NCT ID: NCT04302740 Active, not recruiting - Clinical trials for Alcohol Use, Unspecified

Life Enhancing Alcohol-management Program

LEAP
Start date: February 21, 2020
Phase: N/A
Study type: Interventional

People experiencing chronic homelessness comprise a small yet high-morbidity, high-cost subset of the larger homeless population and are disproportionately impacted by alcohol-related harm. Unfortunately, traditional abstinence-based treatment does not adequately reach or engage this population, and both firsthand (problems stemming from one's own alcohol use) and secondhand (problems stemming from others' alcohol use) alcohol-related harm persists even after housing attainment. There have therefore been calls for more flexible and client-centered approaches tailored to this population's needs. Housing First, which entails the provision of immediate, permanent, low-barrier, nonabstinence-based housing, is a response to this call. Research has shown that Housing First is associated with decreased alcohol use, alcohol-related harm, and publicly funded service utilization. Nonetheless, Housing First residents continue to experience both first- and secondhand alcohol-related harm. Thus, further community-based interventions are necessary. To this end, a pilot project was conducted in which researchers as well as Housing First residents, staff and management codeveloped, implemented, and initially evaluated the Life Enhancing Alcohol-management Program (LEAP). The LEAP entails low-barrier, community-level, house-wide resident programming-including leadership opportunities, activities, and pathways to recovery. At the 6-month follow up, LEAP participants reported significantly more engagement in meaningful activities than control participants (p < .001). Moreover, high levels of LEAP program engagement (>2 activities per month) predicted significant reductions in alcohol use and alcohol-related harm (ps < .01). To build on these promising findings, we propose a larger, cluster-randomized controlled trial of LEAP (N=160) as an innovative, community-based, and client-driven adjunct to Housing First. Analyses will test LEAP effectiveness in increasing engagement in meaningful activities, decreasing alcohol use, ameliorating both first- and secondhand alcohol-related harm, and improving quality of life. Engagement in meaningful activities will also be tested as a mediator of the LEAP effect on alcohol and quality-of-life outcomes. Finally, we will assess whether LEAP is associated with reduced costs stemming from participants' use of emergency health-care and criminal justice services.

NCT ID: NCT04268173 Completed - Hepatitis C Clinical Trials

Community-Based, Client-Centered Prevention Homes to Address the Rural Opioid Epidemic- Aim 3

Start date: March 12, 2020
Phase: Phase 3
Study type: Interventional

The goal of this study is to effectively use a client-centered community-based intervention to engage people who inject drugs (PWIDs) in healthcare that helps reduce risky behaviors and lower infectious disease risks. Participants in the intervention group of this study will undergo a 12-week intensive multilevel harm reduction case-management intervention at three rural Vivent Health offices geared towards reducing human immunodeficiency virus (HIV), hepatitis C virus (HCV), and overdose risks in PWIDs. Prevention Navigators (PNs) at each office will help coordinate referrals to reduce substance use disorder and increase engagement in the substance use disorder care cascades. PNs will also engage participants in HIV, HCV, and sexually transmitted infections(STIs) care cascades.

NCT ID: NCT04253158 Completed - Alcohol Drinking Clinical Trials

Implementation of a Web-based Alcohol and Other Drug Prevention Intervention for Collegiate Student-athletes

Start date: September 1, 2011
Phase: N/A
Study type: Interventional

The broad aim of the proposed study is to use the innovative Multiphase Optimization Strategy to develop a highly effective Internet-delivered intervention, myPlaybook, for the prevention of substance use among college student-athletes. myPlaybook will undergo two rounds of randomized experimentation and targeted revision. At the conclusion of the second round, the optimized version of myPlaybook will be evaluated in large-scale Randomized Controlled Trial (RCT).

NCT ID: NCT04250727 Completed - Clinical trials for Tobacco Use Disorder

Switching to Potential Reduced Exposure Products in Adult Smokers

ZYN
Start date: May 1, 2021
Phase: N/A
Study type: Interventional

This study aims to assess the feasibility, acceptability, and the potential harm reduction of switching to potentially lower risk, oral nicotine pouches in adult smokers. Part One of this study aims to assess the interest of current smokers in switching to an e-cigarette device (i.e. JUUL) compared to alternative non-combustible tobacco products (i.e. smokeless tobacco/snus) and/or medicinal nicotine via survey. Part Two will consist of a pilot study of 30 non-treatment seeking adult smokers to investigate within-person changes in smoking behavior as a result of switching to different concentrations of oral nicotine pouch products (i.e. ZYN, 3mg and 6mg nicotine concentration). Additionally, by measuring bio-markers of tobacco exposure from baseline, this will allow the study to assess the potential for harm reduction in switching from cigarettes to oral nicotine pouches.

NCT ID: NCT04210180 Completed - Smoking Cessation Clinical Trials

Combination of E-cigarettes and Varenicline for Tobacco Harm Reduction

EVAR
Start date: November 19, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This open-label study will explore the impact of varenicline on the process of switching from combustible cigarettes (CC) to an e-cigarette. Varenicline is currently the most efficacious single pharmacotherapy for smoking cessation, and through its actions as an agonist or partial agonist at various nicotinic acetylcholine receptor subtypes, serves to diminish the rewarding effects of cigarette smoking. Diminishing the rewarding effects of smoking might facilitate the transition from CC to e-cigarettes. On the other hand, varenicline might attenuate the rewarding effects of nicotine-containing e-cigarettes as well, which could hamper the transition. Thus, the study will provide important information about the actions of varenicline on CC as well as e-cigarettes. There is no therapeutic intent in that smokers' nicotine/tobacco dependence will not be treated; the goal is to switch from one form of nicotine/tobacco dependence (CC) to dependence on a different tobacco product (e-cigarettes).

NCT ID: NCT04188197 Recruiting - Smoking Cessation Clinical Trials

Assisting Smokers to Switch to a JUUL E-Cigarette by Devaluing Combustible Cigarettes

RECON
Start date: August 26, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate a reward devaluation strategy in which smokers use the JUUL e-cigarette immediately before any combustible cigarettes (CCs) are smoked. This procedure is predicted to accomplish three goals: 1) the rewarding effects of CC will be disrupted because subjects will already have attained fairly high peak nicotine concentrations immediately before smoking the cigarette. This reduces the rewarding effect of smoking, in part from receptor desensitization that occurs following nicotine exposure, which reduces the response to a subsequent dose of nicotine, and in part from satiating the drive to smoke; 2) the use of the JUUL will become associated with the same cues that elicit smoking, thereby promoting the substitution of JUUL use for CC use; and 3) ad libitum nicotine intake from the JUUL and its rewarding effects will be maximized because, unlike CC, they will be experienced after a period of nicotine deprivation. Thus, despite a lower per-puff nicotine dose relative to CC, the pharmacologic impact and reinforcing effect will be maximized. The study will evaluate two flavors (Mint and Virginia Tobacco), randomly assigned, to determine if flavor assignment (similar to the subjects' usual brand of CC or different than the subjects usual brand CC) has an effect on the success of this reconditioning procedure.