Clinical Research Directory

Tobacco Product Susceptibility and Substitutability by Rurality and Alcohol Use

A high priority research area for the Food and Drug Administration Center for Tobacco Products (FDA CTP) is determining who will start using tobacco products and who will stop using tobacco products. A population that has a disproportionately high amount of tobacco use are people living in rural areas. This indicates that some aspect of rurality is related to tobacco product susceptibility and decreased tobacco cessation rates. People in rural areas also typically have higher rates of alcohol use, which is also associated with higher tobacco use and decreased tobacco cessation rates. The purpose of this study is to (1) examine how rurality and alcohol use may affect susceptibility to existing and novel tobacco products and (2) examine how rurality and alcohol use may affect likelihood for tobacco users to substitute to tobacco cessation products. To accomplish this, the investigators will use behavioral economic measures to assess how people respond to novel tobacco products (high and low nicotine, flavored and unflavored), as well as use the experimental tobacco marketplace to determine how current users might switch to products associated with cessation. Because rurality is a spectrum, the investigators will be using an index of relative rurality (IRR) to better quantify how rurality and alcohol use affect these tobacco-related behaviors.

Maternal Outcomes: Mood, Alcohol Use, and Depressive Symptoms

This study aims to learn about depression and alcohol use in postpartum mothers and whether an intervention based on contingency management and problem-solving therapy (CM-PST) can help reduce these symptoms. The main questions it seeks to answer are: 1. How do new mothers fare with depressive symptoms and alcohol use in the first 12 months after giving birth? 2. Will a CM-PST intervention reduce depressive symptoms and alcohol use frequency among new mothers? 3. Is a CM-PST intervention practical for new mothers? The researchers will recruit approximately 30 new mothers and randomly select half to attend a 6-week CM-PST intervention. They will compare those who received the intervention versus those who did not to see if there are any differences in their depressive symptoms and alcohol usage. Participants will: * Complete 4 remote intervention sessions over 6 weeks * Conduct at-home urine drug tests 2x per week during the 6-week intervention * Answer online surveys about their mental health and alcohol use

Parent-Focused Alcohol Prevention Program for Hispanic Families in Faith-Based Settings

The goal of this clinical trial is to determine whether Guiando Buenas Decisiones, a parent-focused alcohol prevention program, can help prevent or delay alcohol initiation and use among Hispanic immigrant adolescents ages 12 to 14 from low-income families. The study will also examine how well the program can be implemented through a faith-based community organization. The main questions this study aims to answer are: 1. Does the refined Guiando Buenas Decisiones program help prevent or delay alcohol initiation and use among adolescents? 2. Does the refined Guiando Buenas Decisiones program improve family, individual, and sociocultural risk and protective factors related to adolescent alcohol use, as reported by parents and adolescents? 3. What individual- and organizational-level barriers and facilitators affect implementation of the refined Guiando Buenas Decisiones program? 4. What are the reach, adoption, implementation, and maintenance outcomes of delivering the refined Guiando Buenas Decisiones program through a faith-based community organization? The study will first conduct a small pilot to refine Guiando Buenas Decisiones and optimize the intervention and study procedures based on feedback from participating families. The study will then conduct a randomized controlled trial comparing families who receive the refined Guiando Buenas Decisiones program with families assigned to a wait-list control group. Families in the wait-list control group will be offered Guiando Buenas Decisiones after completing the 6-month follow-up assessment. The refined Guiando Buenas Decisiones program consists of seven weekly sessions, each lasting approximately 2 hours, delivered by trained community health workers and lay church members. In the randomized trial, parents and adolescents will complete separate assessments at baseline, immediately after the intervention, and 6 months after the intervention. These assessments will examine adolescent alcohol initiation and use and family, individual, and sociocultural risk and protective factors related to adolescent alcohol use. Information will also be collected from parents, program facilitators, and organizational stakeholders to identify individual- and organizational-level barriers and facilitators to implementation and to assess implementation outcomes in a faith-based community setting.

The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)

This proposed study is a double-blind, randomized, placebo-controlled, parallel-group, laboratory study to determine the effects of DMT, plus psychotherapy, on Alcohol Use Disorder.

Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making

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.

HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 1

This pilot intervention will consist of a brief intervention for patients with HIV who take 5 or more medications and currently (within the past month) consume alcohol. The focus of this pilot will be on bothersome symptoms and the impact of alcohol use and medications on these symptoms. The rationale is that any alcohol use may interact with medications in serious ways leading to adverse outcomes, including bothersome symptoms.

Efficacy of the Proactive Automatized Lifestyle Intervention

Background: Individual brief behavior change interventions often do not sufficiently address the common co-occurrence of multiple health risk behaviors among people. In addition, many interventions often fail to reach the majority of the target population and particularly those people who need them the most. To address these core challenges of individual prevention research, the "Proactive Automatised Lifestyle intervention (PAL)" was developed, a proactive screening and brief intervention driven by psychological health behavior change theory to motivate participants for behavior change. The trial ePAL aims to investigate the efficacy of the multi-behavior change intervention adressing tobacco smoking, alcohol use, diet and physical activity among general hospital patients over 2 years; and to investigate differential efficacy in different subgroups of patients. Methods: All patients admitted to non-intensive care wards on five medical departments within the University Medicine Hospital Greifswald (internal medicine A \& B, surgery, trauma surgery, ear-nose-throat) and aged 18 to 64 years are systematically approached by study assistants and asked to first participate in a survey and then in the randomizd controlled trial, irrespective of their reason of admission. A total of 788 participants is allocated to two study groups. The intervention group receives individualized feedback on all four health risk behaviors to enhance motivation to change identified health risk behaviors. The feedback is driven by psychological behavior change theory, tailored to the participants' current stages of change and delivered after baseline and at months 1 and 3. The control group receives routine care and minimal assessment only. Follow-ups are conducted at months 6, 12 and 24 after baseline; and more are planned for. Efficacy will be measured concerning self-reported change in health risk behaviors, health and motivation to change measures using latent growth curve modelling. Discussion: The trial will provide information on the efficacy of a population-based and individually tailored brief intervention to systematically provide individualized feedback to each patient for a healthy living. When found to be effective and implemented widely, such interventions may contribute to the prevention of widespread non-communicable diseases.

Smartphone-based Intervention for Young Adults With ADHD

The primary goal of this clinical trial is to test if a smartphone-based intervention is feasible \& acceptable among young adults with ADHD who also engage in risky drinking behaviors. A secondary aim is to test preliminary intervention efficacy. The main questions it aims to answer are: Is the smartphone intervention feasible \& acceptable for participants (e.g., are they responding regularly, is there a low level of burden reported)? Does the smartphone intervention improve symptom awareness, inhibitory control, and problematic alcohol use? Participants will: Attend a virtual baseline visit to assess ADHD, alcohol use, and other life experiences. Complete either the TIPS smartphone intervention or a control smartphone protocol over the course of 31-days, starting the first Friday after the baseline visit. Attend a virtual follow-up visit, where many of the same questions from the baseline visit will be asked again.

Wellness, Alcohol, Vitals, and Emotions

The goal of this clinical trial is to examine the effects of mindfulness based relapse prevention on self-regulation overtime and drinking in daily life through the use of wearable heart rate sensors during mindfulness groups and answering assessment questions 3 times per day during the course of treatment. The main questions that it aims to answer are: 1. What changes in self-regulation as measured through heart rate variability are observed during a mindfulness intervention and how do those self-regulatory changes affect drinking after treatment? 2. How do changes in heart rate variability affect drinking, craving, and negative affectivity in daily life? Participants will: 1. Answer questions related to their mood and drinking behaviors. 2. Wear their sensors during an 8-week treatment period with 1 group per week. 3. Answer questions 3 times a day during the treatment period. 4.) Return their sensors via a pre-stamped package and answer questions about their mood and drinking behaviors 3- and 6-months after the mindfulness groups end.

CPNF Intervention Development and Testing

The project will develop brief interventions that allow participants to customize which groups they receive feedback for in relation to things such as drinking norms for younger or older students, student athletes, etc. The goal is to provide content that is meaningful and engaging to all users.

A Community-Based Intervention to Reduce Alcohol Use in Vietnamese Men

This study aims to evaluate the effectiveness of a community-based Protective Behavioral Strategies (PBS) program in reducing alcohol use, severity of alcohol-related problems, and intention to use alcohol among people with hazardous alcohol use (HAU) in Vietnam. In this randomized controlled trial, 104 men aged 35-44 years, identified as having HAU (Alcohol Use Disorders Identification Test score = 8-15), will be recruited from a rural area in Thai Nguyen province, Vietnam. Participants will be randomly assigned in a 1:1 ratio to either the intervention or control group using stratified blocked randomization. The intervention group will participate in a community-based PBS program, which includes five weekly 90-minute sessions, with Short Message Service (SMS) reminders sent three times weekly after each session to reinforce PBS practices. The control group will receive usual care only. The primary outcome is alcohol use, assessing both the quantity and frequency of consumption, measured at 1 month and 3 months post-intervention. Secondary outcomes include the severity of alcohol-related problems and intention to use alcohol. These will be assessed at baseline and the 3-month follow-up. Two-way repeated measures Multivariate analysis of variance (MANOVA) and regression models will be conducted to evaluate the effects of the intervention on the primary and secondary outcomes.

Better Experiences in Substance Treatment: A Brief Alcohol-focused Intervention Tailored for Patients in Opioid Agonist Treatment

This study will help determine the feasibility and acceptability of a brief opioid-informed alcohol intervention in patients receiving prescribed buprenorphine for opioid use who are currently drinking alcohol. It will also provide initial information on whether the intervention improves outcomes related to alcohol use. The results of this proof-of-concept study will inform whether a future larger clinical trial is warranted.

Multi-Component Breath Alcohol Intervention Phase 3

This is the third stage of a three-stage, NIH-funded study to develop and test a multi-modal intervention concerning blood/breath alcohol concentration for young adults who drink heavily. The multimodal intervention will be made up of brief telehealth counseling and psychoeducation and use of three existing mobile technologies. The brief counseling/psychoeducation and mobile technologies provide personalized feedback regarding blood or breath alcohol content. The long-term goal of use of these mobile technologies will be to facilitate moderate drinking. However, the main goals of the proposed research are to learn more about feasibility of our procedures, perceived value of the technologies and ease of use from the research participants' points of view. In this third stage of the study, the investigators will conduct a randomized controlled trial building on the formative research conducted in Stages 1 and 2.

Testing an MBI for Smoking Cessation and Alcohol Use Among Cancer Survivors

This study will examine the efficacy of Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) compared to standard care among cancer survivors who smoke cigarettes and engage in at-risk alcohol use. Investigators will evaluate implementation outcomes through structured stakeholder interviews across medical centers, cancer-focused organizations, and community-based programs in Florida, and will conduct a cost-assessment and an incremental cost-effectiveness analysis of the two conditions.

Alcohol and Cannabis Co-Use and the Gut-Brain Axis

This observational study aims to improve our understanding of how legal market cannabis use impacts acute and long-term alcohol use, the microbiota-gut-brain-axis (MGBA), and neurobehavioral alcohol use phenotypes such as impulsivity, impaired cognitive functioning, and craving, among individuals who regularly use both alcohol and cannabis. Over a period of one month, subjects will participate in this three-visit study. Blood samples will be collected to allow for the assessment of inflammatory markers and cannabinoids, a fecal sample will be collected to allow for the analysis of the gut microbiome, and participants will complete cognitive and impulsivity tasks and provide craving ratings during the course of an alcohol self-administration procedure. Subjects will also participate in two 14-day daily diary data collection periods between lab sessions. Daily diary data collection will be used to assess the effects of cannabis use on alcohol use and craving longitudinally.

Multi-Component Breath Alcohol Intervention

This is the first stage of a three-stage, NIH-funded study to develop and test initially a multi-modal intervention concerning blood/breath alcohol concentration for young adults. The multimodal intervention will be made up of brief telehealth counseling and psychoeducation and use of three mobile technologies to facilitate moderate drinking. In the first stage of the study, we will conduct formative research to obtain input from the study population, test initially the telehealth version of the brief counseling and psychoeducation and to develop a simple, "low tech" approach to coaching participants to use the three mobile technologies in typical drinking situations. Participation will last approximately one month.

Impaired Risk Awareness During Intoxication in DUI Offenders

This study aims to test the efficacy of experiential-based training to increase DUI offenders' perceptions or risk associated with alcohol use.

College Student Alcohol Behaviors and Strategies

The primary goal of this clinical trial is to examine whether the use of personalized goal setting related to protective behavioral strategies (PBS)-behavioral techniques enacted before, during, or after alcohol consumption to reduce risk and minimize harm-increases the use of personally selected PBS implementation. A secondary goal of this trial is to examine whether increasing the frequency of PBS use will lead to decreases in alcohol consumption, fewer alcohol-related negative consequences, and increased alcohol-related positive consequences. Researchers will compare a control condition, a PBS-only condition, and a PBS+Goals condition to address the aims of the study. Participants in all conditions will complete measures about current PBS use, alcohol use and consequences, and likelihood and confidence to change current alcohol and strategy use. All participants will receive brief psychoeducation on PBS. Participants in the PBS-only and PBS+Goals condition will select three PBS to use over the following two weeks, and select a strategy for remembering the PBS they chose. Participants in the PBS+Goals condition will receive psychoeducation about goal setting and identify two goals related to each PBS strategy they selected. Participants in all conditions will complete a follow-up after two weeks containing measures about PBS use, alcohol use and consequences, and likelihood and confidence to change alcohol and strategy use. Participants in the PBS-only and PBS+Goals condition will complete a measure to indicate whether they used the reminder strategy they selected at the two-week follow-up. Participants in the PBS+Goals condition will complete a measure indicating whether they believe they achieved their goals at the two-week follow-up.

Brief Interventions to Reduce Comorbid Alcohol and Cannabis Misuse and Sleep Impairment in Young Adults (Rest-Up RCT)

This study is designed to evaluate an integrated intervention to reduce alcohol and marijuana use and consequences and improve sleep among young adults with comorbid heavy episodic drinking, marijuana use, and sleep impairment.

Mechanistic Evaluation of Guanfacine on Drinking Behavior in Women and Men With Alcohol Use Disorders

For this protocol, the investigators plan to collect pilot data to examine sex differences in guanfacine's effect on 1) counteracting stress and stimulation based drinking behavior in the laboratory and 2) improving clinical outcomes during a subsequent treatment phase.

Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems

Intervention for mild severity alcohol use among U.S. teens is crucial, as alcohol is the most commonly used substance in this age group, yet few receive the necessary interventions. Primary care, where over 90% of youth regularly visit, is an ideal setting for identifying and addressing mild alcohol use disorder (AUD) through brief interventions like motivational interviewing (MI) and cognitive-behavioral therapy (CBT). However, for teens with mild AUD, a single brief session may not be sufficient, raising questions about the role of caregiver involvement. This study seeks to determine the most effective level of caregiver involvement-no involvement, a single live session, or an online self-paced program-in reducing alcohol use among adolescents with mild AUD in primary care settings. The study also explores the impact of these interventions on other outcomes such as substance use and psychosocial functioning, as well as the factors influencing treatment response. The results will guide the selection and implementation of effective, scalable interventions in primary care to address youth alcohol use disorders.

Get Better Together: Relationship Education For Military Couples

This study is testing a program called Get Better Together, a relationship education program designed to help military couples effectively navigate life stressors as a team. The goal is to find out if attending Get Better Together improves mental health and relationship skills, and reduces problems like alcohol misuse, aggression, and suicide risk. Couples who join the study will be randomly placed into one of two groups. One group will attend Get Better Together at a weekend retreat. The other group will continue their usual activities and later receive access to an online relationship education program. All participants will complete surveys before the retreat and again 2, 4, and 6 months later.

CBT vs. Supportive Texts for PTSD & Hazardous Drinking (Project Better Study 2)

The study aims to test the efficacy of a CBT-enhanced text message intervention and a supportive text message intervention to reduce symptom burden in individuals with post-traumatic stress disorder symptoms and co-occurring hazardous drinking.

The Less is More Study

In this project, the investigators will implement innovations to extend use of Contingency Management (CM) to facilitate alcohol use reduction among people living with HIV (PLWH). The investigators' approach to extending CM will use mobile health (mHealth) tools including a smartphone breathalyzer device with accompanying app and a wrist worn alcohol biosensor. Participants will be engaged in mobile facilitated CM for 30-60 days with follow-up out to 6 months.