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Alcohol use is prevalent in U.S. adolescents and contributes to adverse health outcomes in this population. Care for adolescent alcohol use is lacking in most pediatric primary care settings (PPC). This project is a pragmatic comparative effectiveness and implementation study that employs a superiority, two-arm, randomized, prospective, observer-blinded, controlled trial design to compare the effectiveness of a patient-centered brief motivational interviewing-based alcohol intervention (BMAI) alone to the same BMAI augmented with adjunctive smartphone app-delivered mindfulness training (MT) for alcohol use in adolescents receiving primary care in PPC clinics across a regional health network. Main effectiveness outcomes will be alcohol use and alcohol related problems assessed over a one-year follow-up period. Implementation outcomes and mediators and moderators of intervention response will also be examined as part of the study.
This study aims to design, implement, and evaluate a pilot test of a web-based Mindfulness-Based Relapse Prevention (MBRP) continuing care intervention to support individuals with alcohol use disorder (AUD) exiting standard outpatient treatment. Guided by the Centre for eHealth and Wellbeing Research (CeHRes) roadmap, the project follows a structured framework for digital intervention development: (1) contextual inquiry, (2) value specification, (3) design, (4) operationalization, and (5) summative evaluation. Contextual inquiry is defined as gathering information from the intended users and the environment in which the technology will be implemented. The next step, value specification, is defined as the quantification of the values of the key stakeholders, where the user requirements for the technology and the most favorable solutions emerge. This process elaborates on what was discovered in the contextual inquiry step and an analytical hierarchy is conducted to assign quantifiable values to the stakeholders' priorities for the intervention. Design is the step defined as the process of building prototypes of the technology that fit with the values and requirements of the stakeholders, and then testing the prototype in realistic situations. Operationalization is the implementation of the intervention. The final step, summative evaluation, is the assessment of the intervention's impact. The research team plans to conduct a needs assessment (Aim 1a), develop (Aim 1b), implement (Aim 2a), and evaluate (Aim 2b) a pilot test of a web-based MBRP continuing care intervention, named "Renewed Recovery", targeting individuals exiting standard outpatient treatment for alcohol. Aim 1: Design a web-based mindfulness continuing care intervention. Aim 1a: Conduct a community needs assessment. To understand the need for such an intervention, semi-structured qualitative interviews with program administrators (n=3) from partnering substance use treatment facilities will be conducted (contextual inquiry). To better understand the recovery journey after exiting standard outpatient treatment, semi-structured interviews with individuals (n\~10) who have been in treatment more than once will be conducted (contextual inquiry). After interviewing the 2 stakeholder groups, a meeting will be held to determine their list of priorities for this project (value specification). Aim 1b: Develop the intervention website (design). The website for the intervention will be created by creating multiple wireframe iterations and presenting them to the stakeholders to determine the best formatting. The curriculum on the site will be modeled after the original MBRP curriculum. After coming to a consensus on the best version of the website, a usability test will be conducted of a newly created prototype with the same 10 individuals who identified as having been in treatment more than once. A quantitative survey will be employed and a focus groups will be held to assess the usability, equitability, enjoyability, and usefulness of the website. Aim 2: Implement and evaluate the pilot test at partnering treatment facilities. Aim 2a: Implement the pilot test of the web-based MBRP continuing care intervention (operationalization). After altering the intervention based on the usability test, the program will begin to be implemented. 30 people (3 groups of 10) will. Be recruited to participate in the intervention that will be 8 weeks in length (1 module per week, for a total of 8 modules), composed of a self-guided curriculum of text and videos, as well as two zoom sessions to practice meditating as a group. Aim 2b: Evaluate the pilot test to determine process and behavior outcomes (summative evaluation). To measure process outcomes, surveys will be employed asking about the usability, equitability, enjoyability, and usefulness of the website as well as their overall satisfaction with the intervention. Recruitment and retention rates will be another identifier of process outcomes. To measure behavior outcomes, participants will be given a multitude of measures at baseline to measure relapse, anxiety, depression, self-efficacy, coping mechanisms, social support, acceptance, mindfulness, and reactivity to triggers. Analysis of these measures will be done via multilevel modeling. These measures will also be given at the completion of the program and at 3 months after completion.
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in the treatment of AUD in subjects with obesity or overweight. After signing the informed consent form, subjects will be screened and if eligible randomized 1:1 to 1 of the following 2 treatment arms: * Pemvidutide: 2.4 mg SC once weekly * Placebo: Placebo SC once weekly
This study is a phase 2 single-site, double-blind, placebo-controlled, randomized clinical trial with an open-label extension phase to examine the safety of psilocybin (25 mg) combined with psychological support (Psi-PS) for treatment of approximately 40 military veterans and first responders (ages 21-65) with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). Psychological support is defined as providing safety, reassurance, active listening, and empathetic presence during the drug administration session in a nondirective manner. We hypothesize that Psi-PS may provide a safe treatment for participants. The primary objective of study is to characterize the safety of psilocybin combined with psychological support (Psi-PS) for individuals with co-occurring alcohol use disorder (AUD) and PTSD.
The purpose of this single groups trial is to (Aim 1) determine relationships between alcohol use, suicidal thoughts and behaviors (STBs), and behavioral economic decision-making in a community sample (N = 100) of alcohol using adults who are 18 years of age or older, (Aim 2) is to determine factors that predict engagement with a remote intervention (computer based training for cognitive behavioral therapy; CBT4CBT) for alcohol and its effects on alcohol use, STBs, and decision-making with those same adults. Participants will complete a baseline assessment and be given access for remote, self-guided CBT4CBT modules for alcohol use. Following this, participants will remotely complete three follow-up assessments over three months. This will allow for determination of incidence and predictors of alcohol use and STBs and determination of predictors of engagement and efficacy of a remote intervention for alcohol use in both samples.
The objective of this proof-of-concept study to evaluate mazdutide in participants with alcohol use disorder (AUD). For any individual participant, the maximum duration of study participation is approximately 36 weeks, including screening and posttreatment follow-up.
Background: People with alcohol use disorder (AUD) also often have bouts of depression called major depressive episodes (MDEs). People having MDEs have been found to have low levels of a protein called PDE4B in the brain. Researchers want to find out if people with AUD also have low levels of PDE4B. This research may help lead to better treatments for AUD. Objective: To find out (1) if PDE4B levels are lower in people who are withdrawing from AUD and (2) if their PDE4B levels go up after they abstain from alcohol for 3 to 4 weeks. Eligibility: Adults aged 18 to 70 years with AUD. They must be enrolled in protocol 14-AA-0181. Design: Participants enrolled in protocol 14-AA-0181 will stay in the clinic for 3 to 4 weeks for alcohol withdrawal. During this stay, they will have some added procedures for the current study. Within the first week, participants will have a positron emission tomography (PET) scan of the brain. A needle will be used to guide a thin plastic tube (catheter) into a vein in one arm. An experimental substance called a radioactive tracer will be injected through the catheter. This tracer binds to PDE4B and makes it easier to see the protein in the brain. For the scan, participants will lie on a table that slides into a doughnut-shaped machine. Participants will have a second PET scan toward the end of their stay in the clinic. Participants may also have a magnetic resonance imaging (MRI) scan of the brain. They will lie on a bed that slides into a tube....
The goal of this clinical trial is to reduce heavy drinking and enhance medication for opioid use disorder (MOUD) outcomes in individuals receiving MOUD. The main questions it aims to answer are: * Does the brief, digitally-enhanced, virtual psychotherapeutic intervention, called Managing Physical Reactions to Overwhelming Emotions (IMPROVE), impact daily alcohol use and MOUD adherence? * Does the intervention change self-report and physiological responses to intolerance to uncertainty and anxiety sensitivity? Researchers will compare IMPROVE to a control intervention (health education treatment) to see if IMPROVE impacts daily alcohol use and MOUD adherence. Participants will: * Complete a baseline electroencephalography (EEG) and self-report questionnaires. * Complete three one-hour intervention sessions (IMPROVE or control) each one week a part. * Complete a post-intervention EEG and self-report questionnaires. * Complete five ecological momentary assessment (EMA) surveys a day for 21 days. * Complete self-report questionnaires one-month after their last intervention session.
The goal of this study is to learn if PT150 can reduce the behavioral and physical effects of stress, alcohol, and alcohol use in people with alcohol use disorder.
The two primary objectives of this study are to test whether intermittent theta-burst (iTBS) can affect behavioral change as compared to treatment as usual (TAU, sham) in individuals with alcohol use disorder (AUD) in inpatient substance use treatment. The secondary objective is to determine whether iTBS reduces the risk for relapse at four months compared to sham. It is hypothesized that individuals who receive iTBS treatment will show attenuated prefrontal cortex (PFC) CNS responses to alcohol related cues and reductions in risk-taking behavior and impulsivity as measured by PFC responses measured by functional near infrared spectroscopy (fNIRs). The proposed approach will be to measure the effect of iTBS treatment on PFC CNS response. Participants will be randomized to receive 5 days (4 x sessions/day x 600 pulses/session = 12,000 pulses) of iTBS or sham to the left dorsal lateral prefrontal cortex (dlPFC) while being exposed to alcohol cues five minutes prior to treatment and during treatment. The investigators will target the Beam/F3 scalp location and use the TMS Navigator Research Premium stereotaxic system for neuronavigation. PFC response data will be gathered using fNIRs measuring cue reactivity, risk-taking (Balloon Analog Risk Test), and impulsiveness (Go No Go task). The primary outcomes will be the mean changes in pre-post PFC response data gathered using the fNIRs sessions. The rationale for this approach is that TBS can be delivered over a shorter time frame than rTMS and may require fewer sessions, allowing for a better fit within a 28-day inpatient treatment stay.