View clinical trials related to Substance-Related Disorders.
Filter by:This study has been designed to conduct a pilot evaluation of a novel model of support aimed at promoting community integration (CI) following homelessness. This model is called the Peer to Community Model (P2C). The P2C model is an outreach peer support model aimed at facilitating CI for individuals living with concurrent disorders following homelessness. This approach uses relationship-building and engagement in meaningful activity facilitated by peer support specialists (PSS) in concert with occupational therapy (OT) and social work (SW) consultation. This model includes four distinct components: 1) peer support delivered in a community space dedicated to the program or community locations at a maximum ratio of 10:1; 2) OT and SW offering consultation to PSSs and service users; 3) a weekly support meeting for PSSs, OT and SW aimed at providing a venue for problem-solving through complex cases and providing mutual emotional support in the context of service delivery with a complex population; and 4) opportunities for social enterprise (developing ideas for income generation) within the community space. ***NOTE: This is a single model of support that includes the components identified above - these are not separate interventions, but various components of one intervention designed in previous research by the study team. In this clinical trial, the investigators will implement the P2C model for the first time. The study team will conduct a pilot study using an open randomized controlled trial, crossover design. A total of 20 participants will be assigned randomly to the intervention group, where they will receive P2C supports at baseline, and 20 participants will be assigned to a waitlist condition for six months, after which time, they will be offered the P2C intervention. Participants will be interviewed at baseline and every three months using mixed (qualitative and quantitative) interviews. Waitlisted participants will be interviewed during these same intervals using the same interview protocols, and while waiting, will receive care as usual.
Using a 2-group, mixed method cluster randomized trial design, this study will compare standard implementation versus RAPD implementation strategy in Michigan Middle Schools
The United States is in the midst of an opioid crisis. Over-prescription of opioid analgesic pain relievers contributed to a rapid escalation of use and misuse of these substances across the country. In 2016, more than 2.6 million Americans were diagnosed with opioid use disorder (OUD) and more than 42,000 have died of overdose involving opioids. This death rate is more than any year on record and has quadrupled since 1999 (1,2). Leveraging the potential of available data bases and health IT technologies may help to combat opioid crisis by targeting various aspects of the problem ranging from the prevention of opioid misuse to OUD treatment. NIH through NIDA solicits the research and development of data-driven solutions and services that focus on issues related to opioid use prevention, opioid use, opioid overdose prevention or OUD treatment. In this project, We The Village, Inc. will address a need to prepare Concerned Significant Others (CSOs) to best use their influence over the trajectory of a loved one's OUD. CSOs are motivated to help, make majority of treatment decisions and payments and have influence over treatment entry and thus, impact the trajectory of an OUD. The goal of the project is to establish the technical efficacy and commercial viability of CRAFT-A at scale by conducting the fully powered randomized controlled trial (RCT) comparing two online interventions: CRAFT-A (hereinafter referred to as CRAFT or digital CRAFT) and PEER support (the original comparison group). Based on Phase I findings, the team anticipates the CRAFT condition will achieve better outcomes than the PEER condition in a) treatment entry and retention, b) Concerned Significant Others' (CSO) health and wellbeing, c) CSO-IP relationship, and d) CRAFT knowledge.
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.
This study is the first part of a larger project called "Virtual Reality (VR) as a facilitator for participation in society among persons with mental health/substance use disorders" in which aims to explore,develop and evaluate a VR-based paradigm that facilitates social participation and promotes social recovery of individuals with mental health and/or substance use disorders (MHD/SUD). The overall project comprises three work packages: an exploration study, a development study, and an evaluation study. This study will make up work package 1. The primary aim of this study (WP1) is to explore facilitators and barriers for participation in society among person with MHD/SUD, and to provide an understanding of mechanisms of social participation and social cohesion among persons with MHD/ SUD that may be affected by VR-based interventions. The investigators will derive a socio-emotional learning domain to facilitate key interpersonal and social processes among persons with MHD/SUD in VR-based interventions. To achieve the purpose of this study, the invistigators conduct 10 indepth interviews with service-user with MHD/SUD, 2 focus group interviews with 14 service-providers and an interview-survey with 100 service users. This gives the investigators the possibility to explore facilitators and barriers for social participation as experienced as by individuals with MHD/SUD and identify key interpersonal and social processes suitable to be addressed by tailored VR based interventions.
This research study is being done to develop an intervention for psychological symptoms that patients diagnosed with cancer may experience. Psychological symptoms may include thoughts, feelings, emotions, and memories The names of the study intervention and research activities involved in this study are/is: - Acceptance & Commitment Therapy (ACT) for Cancer (involving 6 sessions with a licensed clinical psychologist) - Questionnaires - Post-study interview Consistent with the NIH Stage Model for Behavioral Intervention Development, the investigators have adapted an existing, empirically-validated intervention, Acceptance and Commitment Therapy (ACT), to address substance use disorder risk during cancer care. The core components of ACT are particularly well-suited to address the psychological processes underlying opioid misuse in individuals treated for cancer pain. The overarching aim is to assess the feasibility and acceptability of the intervention by conducting a randomized pilot trial of the revised intervention ("ACTION") for cancer patients on opioid therapy, and at risk for SUD.
The purposes of the study are 1) To assess the abuse potential of methylone after controlled administration of a single oral dose of methylone 2) to evaluate subjective and physiological effects of methylone 3) to determine the pharmacokinetics parameters and metabolism of methylone.
The substance dependent population has many health needs in which it is necessary to invest in competent approaches with more evidence. The main needs can be minimized when people are trained for self-care (abstinence, risk reduction and harm minimization) and for the necessary adaptations to the impact that these addictive behaviors and dependencies have on their lives and their families' lives. Nursing can play a leading role in interventions aimed at reducing stigma and self-stigma, increasing users' knowledge for recovery, responding to the needs of older consumers, and helping training for self-management of substance dependence. However, about "nursing intervention programs" with people dependent on substances, the evidence is scarce. In many chronic illness situations, people need programs to train and develop a better capacity for self-management of their health situation. Nurses in the Addictive Behaviors area globally closely linked to medication-based programs, hold consultations, manage programs and there is evidence of results that are sensitive to nursing care, however, professionals can and should seek new systematic approaches in response to people's needs and should seek to increase the level of evidence of the result of the interventions. This complex phenomenon can be accompanied by the ability of individuals to manage the severity of the consequences. Based on all this, the following research question emerge: How effective could be an intervention program for training people to manage substance addiction consequences? A randomized controlled trial that will be realized in one specialized unit on addictions, in Lisbon area. Pilot study will be carried out initially. The total sample will be constituted by individuals with substance use disorders, in a medication-based outpatient program, that will be receiving the ADSProgram (experimental group (n=30) and control group receiving treatment as usual (n=30). Both will be aplied for 21 weeks maximum. The General Objective for this research is "To evaluate the effectiveness of a training program for self-management of the substance addiction consequences, with people integrated in medication-based programs". The hypotheses to be tested is that this program is effective to reduce substance addiction consequences.
Background: Loneliness-a subjective emotional state characterized by the perception of social isolation-is a psychosocial factor that is associated with increased mortality, substance use, and is associated with precipitants of relapse among individuals with substance use disorders (SUD). Importantly, there are effective interventions that can be used to decrease loneliness; however, these have not been tested on Veterans with SUD who are lonely. Significance/Impact: Individuals with SUD have higher prevalence of loneliness and loneliness exacerbates pain and sleep disturbance, risk factors of relapse. Without effectively intervening on loneliness, Veterans with SUD will continue to be at high risk of relapse and will maintain problems engaging with social support, including healthcare providers-factors critical for recovery. Cognitive-behavioral therapies (CBT) has shown the strongest effects on loneliness, however, there are no interventions that are specifically designed for substance using populations who are lonely. Testing CBT for loneliness and SUD (CBT-L/SUD) has the potential to have a broad impact on addressing a critical, unmet need that commonly affects Veterans with SUD. The investigators approach of national recruitment and telehealth delivery of this intervention highlights how this this study address VHA care priorities including substance use, access to care, and telehealth. Innovation: There are no studies that have tested a loneliness intervention in Veterans with SUD who are lonely, which may neglect a broader impact on mental and physical health. This study is ideally situated to generate new and important knowledge on the association of loneliness and SUD. This study seeks to address a transdiagnostic factor, which may improve engagement with social support thereby reducing substance use. An additional innovative aspect of this study is recruitment being conducted outside the VHA. This may increase access to care among those Veterans who are especially isolated. Specific Aims: the investigators aim to: (1) refine the CBT-L/SUD manual by conducting a one-arm trial among Veterans with a SUD who report loneliness (n = 6), (2) randomize participants to receive either CBT-L/SUD (n = 15) or CBT-SUD (n = 15) to assess feasibility and acceptability among Veterans with a SUD who report loneliness. Methodology: the investigators will elicit feedback on a draft of the CBT-L/SUD manual then conduct a small single-arm trial (n = 6) for further refinement. Specifically, SUD treatment providers and Veterans with SUD will provide feedback on the draft manual, which the research team will integrate to finalize the manual for a small single-arm trial. This trial will allow us to collect feasibility of treatment delivery, and treatment satisfaction and acceptability data to further refine the manual. With the refined manual Veterans with SUD reporting loneliness will be randomized to either CBT-L/SUD (n = 15) or CBT-SUD (n = 15). The investigators will assess: (1) treatment acceptability, (2) participant adherence to treatment, and (3) therapist fidelity. The investigators will also assess outcome measure completion percentage, means and standard deviations, and level of correlation of repeated measurement of primary loneliness outcomes and secondary substance use outcomes. Implementation/Next Steps: Results from this study will provide critical feasibility and acceptability data to inform an HSR&D Merit Award application to conduct a fully-powered randomized controlled trial. The research team will work with the VA Office of Mental Health and Suicide Prevention and the Substance Use Disorder office of the National Mental Health Program to identify implementation and dissemination efforts. For example, the investigators plan to translate findings into applied practice across various settings (e.g., primary care mental health, rehabilitation treatment programs). Additionally, this intervention may be particularly useful for behavioral telehealth centers that deliver evidence-based interventions to rural and other Veterans who have difficulty accessing VHA care.
Background: About 85% of those receiving opioid agonist therapy (OAT) for opioid dependence are smoking tobacco. Cigarette smoke lead to lunge diseases and cause illness and death within this group. BAReNikotin is a multicentre randomised controlled clinical trial that will test if integration of smoking cessation therapy to clinical practice at OAT-clinics will increase the rate of OAT-patients that quit smoking. Intervention: The patients selected for the intervention arm will receive smoking cessation therapy including weekly brief behavioural interventions and prescription-free nicotine replacement products such as nicotine lozenges, patches and chewing gum for at least 16 weeks. This will be compared to a group of patients, who does not receive any help to quit smoking, apart from intial screening of smoking behaviour and advice on where to buy nicotine replacement products. The patients will have to attend OAT outpatient clinics in Bergen and Stavanger, Norway. The main evaluation will take place 16 weeks after the start of the study. Study population: The target group will be patients with severe opioid dependence receiving OAT from outpatient clinics in the aforementioned cities who are smoking tobacco daily. Expected outcome: The primary goal of the study is to see how many of those patients that are offered smoking cessation treatment, that have stopped smoking or reduced the number of cigarettes smoked by at least one half by the end of the intervention. We will also investigate if quitting smoking changes the well-being, physical fitness and quality of life of the participants. If the nicotine replacement therapy is safe and efficacious, it can be considered for further scale-up.