Clinical Research Directory

Chatbot for Online Support Groups to Treat Tobacco Addiction

Investigators will conduct a pilot RCT to test the efficacy of an intelligent chatbot to aid small, private, quit-smoking peer support groups. Participants will be randomized to an intervention arm (chatbot-enhanced support group), or a control arm (support group only). In the intervention arm (N=60), each support group will be connected to an intelligent chatbot running on a secure local server as a trained LLM (large language model). The intelligent chatbot will function as an additional member of the GroupMe support group, but a member that only responds if no human does so. In the control arm (N=60), the support groups will be connected to an automated message-posting bot running on a secure local server. This automated message-posting bot will lack the response capabilities of the intelligent chatbot. But both the intelligent chatbot and the automated message-posting bot will post a pre-written daily discussion topic to encourage participants to discuss issues known to facilitate tobacco cessation or group bonding.

Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women

Study 2 will evaluate the effects of extended exposure to cigarettes with varying levels of nicotine in pregnant smokers who have less than an Associate's degree. This study will be limited to two conditions: usual brand vs. 0.4 mg nicotine/g tobacco. After a baseline period in which daily smoking rate and other baseline assessments are completed, participants will be randomly (by chance) assigned to either their usual brand or the very low nicotine content condition and followed for 12 weeks.

Smartphone-based Financial Incentives

Cigarette smoking during pregnancy increases risk for catastrophic pregnancy complications, growth retardation, other adverse fetal and infant health problems, and later-in-life chronic conditions among exposed offspring. The most effective intervention for reducing smoking during pregnancy is financial incentives whereby participants earn incentives (e.g., gift cards, cash) contingent on objective evidence of smoking abstinence. However, financial incentives-based interventions are typically delivered in relatively intense protocols requiring frequent clinic visits, which limits the geographical range over which services can be delivered and potentially denies treatment to those residing in remote or otherwise difficult to reach settings. The present study will examine the feasibility, efficacy, and cost-effectiveness of a smartphone-based financial incentives intervention whereby smoking monitoring and delivery of incentives are completed remotely using a mobile app (to be designed by DynamiCare Health, Inc.). Eligible participants who complete the informed consent process will be randomized to one of two conditions: an incentives condition wherein women will receive financial incentives contingent on the remote submission of breath and saliva specimens indicating abstinence from recent smoking (described below), or a best practices control condition in which women will receive usual care for smoking cessation that is provided at their obstetrical clinics, as well as three brief educational sessions and referral to the Vermont (or other state) pregnancy-specific quit line by our research staff. For inclusion in the study, women must meet the following criteria: (a) \> 18 years of age, (b) report being smokers at the time they learned of the current pregnancy, (c) report smoking in the 7 days prior to completing their phone eligibility screening, (c) \< 25 weeks pregnant, (d) speak English, (e) own a smartphone (Android or iOS; 81.8% of pregnant women in wave 1 \[2013-2014\] of the Population Assessment of Tobacco and Health \[PATH\] reported owning a smartphone). Exclusion criteria include: (a) current or prior mental or medical condition that may interfere with study participation (assessed via self-report during phone eligibility screening), (b) smoke marijuana more than once each week and not willing to quit (marijuana smoking can inflate breath CO), (c) exposed to unavoidable occupational sources of CO (e.g., car mechanic), and (d) self-report currently being maintained on opioid maintenance therapy (e.g., methadone, buprenorphine). Participants randomized to the incentives condition will select a quit date (either the first or second Monday following their enrollment), and will submit videos of themselves blowing into a breath CO monitor twice daily during week 1. They will receive incentives for every sample where expired breath CO is \< 6 ppm. Beginning in week 2 and extending through week 6, participants will submit videos twice per week (Monday/Thursday) for which they will receive incentives for providing videos of themselves completing saliva cotinine tests indicating smoking abstinence. From week 7 until delivery, participants will submit videos once per week and will continue to receive incentives for saliva cotinine tests indicating no smoking. During the postpartum period, women will submit videos twice weekly for the first 4 weeks and once weekly from weeks 5-12. Women will receiving incentives for negative breath and saliva samples, and the value of incentives will increase with each consecutive sample indicating smoking abstinence. Participants will not receive incentives for missed samples or samples that indicate smoking, and the incentive schedule will be reset at its starting value. However two consecutive negative samples following a missed or positive sample will restore the incentive to its prior value. Women in both conditions will complete seven formal assessments of their smoking status during their participation along with a treatment acceptability questionnaire and semi-structured interview on barriers and facilitators of treatment engagement. We conducted a power analysis to estimate the number of participants required to detect treatment effects assuming late-pregnancy abstinence rates of approximately 40% vs. \< 10% (incentives vs. best practices, respectively), and 24-week postpartum abstinence rates of approximately 20% vs. \< 5%. The proposed sample size of 76 per treatment condition will result in at least 80% power to detect a difference between the two treatment conditions in abstinence rates of 40% vs. 10 % at late-pregnancy or 20% vs. 5% at 24-weeks postpartum assessments using a chi-square test and significance level of 0.05.

Nicotine Replacement Therapy Prescribing and Lung Cancer Screening in Hospitalized Patients

Investigators are evaluating an EHR-based, non-interruptive alert to increase NRT prescribing in the hospital and at discharge for hospitalized patients. Investigators will investigate two randomized groups of resident physicians to evaluate their prescribing behaviors when the tool is introduced.

TUBSIS 2.0 - Tobacco Use Behavioral Support and Intervention System

Background: Tobacco smoking and vaping remains public health concern, with many adults continuing to experience difficulties accessing appropriate support for smoking cessation in Switzerland and Türkiye. Structural barriers, including stigma related to attempting to quit, limited financial and time resources, low awareness of the health risks associated with tobacco smoking- and vaping-reduce engagement with traditional services. TUBSIS 2.0 aims to address these access inequities by providing a fully remote, anonymous and free internet-based program tailored to diverse adult populations in both countries. Objectives: The "TUBSIS 2.0: An Adaptation Study of Tobacco Addiction Support Programme - TUBSIS for Tobacco Users in Switzerland and Türkiye" project aims to support readiness to reduce or quit tobacco smoking/vaping, improve well-being and self-compassion and strengthen health-related behaviors. The intervention targets German-, English-, and Turkish-speaking adults and includes mindfulness-based strategies for quitting or reducing tobacco smoking and vaping. Motivation to cease tobacco smoking/vaping varies considerably across the lifespan. Younger individuals may perceive smoking/vaping cessation as unnecessary, often due to limited awareness of long-term health risks or a sense of invulnerability. In later adulthood, although addiction tends to be more deeply established, many individuals hesitate to attempt cessation because of concerns about the psychological and behavioral challenges associated with the process. It is therefore essential to provide individuals with support that helps them understand the cessation process, prepare for the challenges that can be expected and identify strategies that align with their psychological needs. Such strategies may include stress management and self-compassion practices that can be utilized before, during and after cessation attempts. TUBSIS 2.0 offers structured and accessible guidance to support this preparation by providing a clear, evidence-based pathway for individuals at different stages of readiness to change. Methods: TUBSIS 2.0 is a web-based, individual and asynchronous program consisting of eight modules delivered over four weeks. A total of 406 participants will be recruited and randomly assigned to either the intervention or control group. Data are collected anonymously at four measurement points (baseline, mid-term, post-term and 8-week follow-up) from participants. The program focuses on supporting participants' reducing or quitting tobacco smoking or vaping; to increase their readiness for smoking/vaping cessation, mental well-being, self-compassion and stress management with mindfulness strategies. Within the Health Action Process Approach (HAPA), the process of behaviour change is conceptualised as a dynamic, non-linear process that progresses through motivational and volitional phases. TUBSIS 2.0 has been adapted to reflect this structure by integrating phase-specific components. These components include modules that enhance risk awareness and outcome expectancies, planning and self-regulation tools to support action initiation and mindfulness-based strategies that are embedded throughout all phases to strengthen self-efficacy and coping. By addressing these shifting needs across the change process, the programme provides a responsive and theory-driven pathway for reducing/quitting tobacco smoking or vaping. Relevance: TUBSIS 2.0 is highly relevant to public health priorities, as it provides a cost-effective, scalable and environmentally sustainable intervention that eliminates barriers commonly associated with traditional cessation services. By requiring no travel, printed materials or in-person appointments, the programme offers equitable access to adults across all age groups, genders and diverse migrant communities in Switzerland and Türkiye. Its multilingual and culturally adapted structure addresses significant service gaps for populations that are underserved or hesitant to seek conventional support. By reducing tobacco smoking- or vaping-related harm and facilitating early behavioural change, TUBSIS 2.0 has the potential to decrease long-term healthcare costs while expanding access to evidence-based digital prevention tools.

Impact of Novel vs. Usual Brand Menthol Cigarettes on Abuse Liability

This randomized, double-blind, crossover human laboratory study compares the abuse liability of cigarettes containing menthol and non-menthol cigarette variants, using the participant's usual brand menthol cigarette as a within-subject reference. Participants complete standardized laboratory smoking sessions, behavioral economic tasks, and a naturalistic observational period. The study examines differences in nicotine delivery, smoking behavior, and subjective effects across cigarette types in laboratory and real-world contexts.

Computer Game, Qualitative, and MEG/EEG Assessment of Serotonergic Psychedelics

This is an observational study which does NOT directly administer a psychedelic substance but rather recruits participants who are already participating in another clinical trial in which they may receive a serotonergic psychedelic. The goal of this observational study is to learn how the brain's information processing changes during and following administration of serotonergic psychedelics (psilocybin, N,N-Dimethyltryptamine/DMT, Lystergic Acid Diethylamide/LSD, etc.) for people with and without mental illness receiving serotonergic psychedelics through any clinical trial at Yale University. The main questions it aims to answer are: 1. Do serotonergic psychedelics cause the brain to rely on new information more than previously learned information while under the influence? What about 1 day, 5-14 days, and 4-6 weeks after use? 2. Do serotonergic psychedelics cause long-lasting side-effects in how people perceive (see, hear, feel, etc.) the world and how easily people change their beliefs? 3. How does the brain's electrical activity change after using serotonergic psychedelics? How does the balance between excitation and inhibition change while under their effect? 4. Can changes in how the brain uses information predict who will benefit from a psychedelic and who will have side effects from psychedelics? Researchers will compare with people given placebos to see what changes in brain processing are unique to serotonergic psychedelics. Participants will have the opportunity to do some combination of the following: 1. Online computer assessments consisting of games and questionnaires that probe how participants think. 2. Magnetoencephalography (MEG) or electroencephalography (EEG) with eyes closed and with repeated clicks, images, or sensations delivered. 3. A magnetic resonance imaging (MRI) scan. 4. Semi-structured qualitative interviews about their experience after taking a serotonergic psychedelic recorded via Zoom.

Beta-Adrenergic Modulation of Drug Cue Reactivity

This study is designed to investigate the effects of a beta-adrenergic antagonist (Propranolol; 40 mg IR) and nicotine patch (14 mg) administered alone and in combination on neurobiological and behavioral responses to smoking cues in ongoing cigarette smokers. This is a basic experimental study in humans and participants will not take these medications for an extended period or make a cessation attempt as part of their involvement in this research project.

Varenicline and Combined NRT for Smoking Cessation

This randomized pilot phase IV trial studies the side effects and how well varenicline works compared to nicotine replacement therapy in helping patients that smoke to quit. Varenicline is a drug that acts the same way as nicotine in the brain but is not habit-forming. Nicotine replacement therapy consists of nicotine patches and lozenges. It is not yet known if varenicline is more effective than nicotine replacement therapy in helping patients quit smoking.

Varenicline for Smoking Reduction in Veterans Not Ready To Quit

In order to reduce the prevalence of cigarette smoking among Veterans, it is vital that healthcare providers offer effective tobacco treatment to all Veterans who smoke, including those not ready to make a quit attempt. Smoking treatments currently available to Veterans who are not ready to quit are only weakly effective. This project will generate new knowledge about the effectiveness of a promising varenicline-based intervention designed to increase quit attempts and long-term abstinence in Veterans who are initially not ready to quit. This project has great potential to engage Veterans not ready to quit smoking in treatment that increases quit attempts and quitting success, thereby reducing morbidity and mortality caused by smoking in Veterans.

Emotional Brain Training for Addiction Medicine Treatment - A Pilot Study

The goal of this clinical trial is to determine whether Emotional Brain Training (EBT), a behavioral modification method, can help manage stress and health problems related to addiction. EBT teaches skills to deactivate harmful circuits (automatic reactions) and activate healing circuits to quickly shift mood from negative to positive. Participants in the EBT group will receive focused, intensive instruction on using these skills to rewire unwanted brain circuits, with the aim of achieving lasting improvements in emotional health and quality of life. The study will assess whether EBT is an effective tool when added to standard of care (SOC), which includes medications for addiction treatment (MAT). Researchers will compare changes in stress, anxiety, and cravings after 8 weeks of EBT plus SOC versus SOC alone. Participants: * will either continue receiving standard treatments (SOC) at the Addiction Recovery Clinic (ARC) at SAC Health in San Bernardino * or receive both EBT and SOC at ARC * in the SOC group will continue monthly visits at ARC and weekly counseling * in the EBT plus SOC group will continue monthly visits and weekly counseling at ARC, along with weekly EBT group sessions by telephone * will complete online assessments at weeks 0, 4, and 8 Upon completion of the study, all participants will resume SOC

Accelerated dTMS Smoking Cessation

The goal of this clinical trial is to examine whether a 5-day course of bilateral accelerated deep transcranial magnetic stimulation (aTMS) is a feasible treatment to help adults (18-65) with Tobacco Use Disorder to quit smoking. This study aims to enroll 30-40 participants and will examine treatment tolerability, treatment acceptability, participant retention, and adherence to scheduled treatment sessions. There are two key objectives and hypotheses: Objective 1: To evaluate whether a 1-week course of bilateral aTMS (4 sessions per day for 5 days) is feasible and tolerable as a smoking cessation treatment. Hypothesis 1: Feasibility will be demonstrated by acceptable tolerability, acceptability, retention, and adherence, with a practical target of 30 out of 40 participants completing the treatment. Objective 2: To explore how aTMS affects smoking outcomes, including: * Point-prevalence abstinence at end of treatment and at Weeks 3, 5, and 9. * Prolonged/continuous abstinence at Weeks 13 and 26. * Craving, cigarettes per day, and dependence severity. Hypothesis 2: Participants will show improvements on these outcomes from post-treatment through follow-up.

A Future Thinking Intervention for Comorbid Tobacco Use Disorder and Bipolar Disorder

Future Self-BD is a 6-session virtual intervention that encourages participants to vividly generate personal and positive future events that they anticipate may be benefited by smoking cessation. Each session will be conducted on HIPAA-compliant Zoom and led by the PI (Dr. Gold).

Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2

This study seeks to determine the feasibility, acceptability, and preliminary efficacy of an intervention consisting of off-label use of a medication with strong efficacy data for alcohol use disorder (AUD) with medical management and a clinical pharmacist-delivered behavioral intervention in reducing alcohol use among individuals with HIV and AUD.

Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment

This trial studies how well smartphone mobile applications work in enhancing smoking cessation treatment in current smokers. Smartphone mobile applications may help current smokers quit smoking.

Cannabidiol for Reducing Cigarette Use

The goal of this research is to evaluate the efficacy of cannabidiol (CBD) in reducing cigarette smoking. Although there are safe and effective treatments for smoking cessation, not everyone who attempts smoking cessation is successful, even with these treatments. Relapse rates are high, leaving a need for new approaches. Despite justification to evaluate CBD for this indication, human research on the topic is scant. Larger, more extended studies are warranted and essential. The investigators will recruit participants from CRI-Help, Inc., a substance abuse treatment program in North Hollywood, where residents who indicate the desire to stop smoking are prohibited from using other cannabis products which would affect recruitment. The aims of this study are: 1. Evaluate the effects of CBD on nicotine intake. 2. Exploratory Aims. Measure plasma concentrations of CBD, N-arachidonoyl-ethanolamine (anandamide) and 2-arachidonoylglycerol (2-AG) at baseline and day 7. Participants who meet eligibility criteria will take part in a 56-day treatment phase during which they receive the study medication under supervision (CBD or placebo twice daily) and complete questionnaires on side effects, withdrawal, craving and mood symptoms. Blood, breath, and urine tests will also be performed throughout the study. Participants who complete the treatment will also be assessed at 1-month and 3-month follow up visits.

Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients

The goal of this clinical trial is to evaluate the feasibility and preliminary effectiveness of auricular acupressure (ear seeds) combined with nicotine replacement therapy (NRT) in psychiatric inpatients (both male and female, aged 18-65) who are forced to abstain from smoking due to the smoke-free environment of the inpatient ward. The main questions it aims to answer are: * Does auricular acupressure significantly reduce the severity of nicotine withdrawal symptoms compared to standard care? * Can auricular acupressure effectively lower nicotine craving and anxiety levels in patients during their mandatory abstinence? Researchers will compare the experimental group (NRT plus active auricular acupressure) to a control group (NRT plus sham auricular acupressure) to see if the addition of ear point stimulation provides better relief for withdrawal distress. Participants will: * Receive standard nicotine replacement therapy (NRT) as prescribed by their physician. * Be randomly assigned to receive either Vaccaria segetalis seeds or sham materials on specific ear acupuncture points. * Be instructed to press the beads 3 times daily to stimulate the points for a period of 4 weeks. * Complete standardized assessments (MNWS, HAMA, and craving scales) at baseline and multiple time points during the intervention.

Engaging Pharmacists to Advance Tobacco Treatment Service Delivery

This research will test the effects of a novel program (ENHANCE-TTS) with tools, training, and clinic facilitation support that capitalizes on pharmacists' roles by expanding their scope of practice to deliver tobacco treatment. This effectiveness-implementation study will evaluate the effects of the ENHANCE-TTS program on implementation outcomes and patient-level smoking cessation outcomes in people living with HIV and concurrently identify key barriers and facilitators to implementing this program in practice.

Cannabis-Tobacco Co-Use Treatment Study

The purpose of the RECLAIM study is to evaluate the effectiveness of varenicline (sometimes known as Chantix) compared to placebo (an inactive substance) for the treatment of cigarettes and cannabis (marijuana). Varenicline is not FDA approved for the combination treatment of cigarette abstinence and cannabis reduction or abstinence. All participants will also receive counseling and access to online treatment modules during a quit attempt for cigarettes and a reduction attempt for cannabis. This study is being conducted by the Medical University of South Carolina. All procedures are conducted remotely and there is no in-person visits are needed. To qualify, participants must be 18 or older, live in South Carolina, use cigarettes and cannabis, and are interested in quitting cigarettes and reducing cannabis.

Quit-Smoking Study for Native Hawaiians

This study aims to help Native Hawaiian adults quit smoking by testing two common methods: nicotine gum and group-based counseling. Participants will be assigned to one of three groups: (1) nicotine gum only, (2) group counseling only, or (3) a combination of both. The study will take place at public housing sites on O'ahu. Researchers will check if these approaches-alone or in combination-can support people in successfully quitting smoking. The goal is to find out which method works best and is most acceptable in this community.

Effects of Nicotine Dependence on Multidimensional Health Outcomes

Nicotine, a major toxic component of cigarette smoke, together with carbon monoxide (CO), constitutes a significant environmental exposure with systemic effects. Beyond its addictive potential, chronic nicotine exposure may induce inflammation, oxidative stress, tissue hypoxia, and autonomic imbalance, potentially impairing respiratory muscle strength, functional capacity, and overall physical performance. Additionally, nicotine dependence has been associated with sleep disturbances, cognitive dysfunction, altered pain perception, and reduced quality of life. Although previous studies have examined individual effects of smoking on specific health outcomes, research addressing these multidimensional impacts within a comprehensive framework remains limited. Therefore, this study aims to investigate the relationship between nicotine dependence level and respiratory muscle strength, functional capacity, cognitive functions, pain, quality of life, physical activity level, and sleep quality, in order to provide a more holistic understanding of the clinical consequences of nicotine dependence.

Facilitation to Increase Tobacco Treatment

Smoking disproportionally impacts Veterans, and VA spends $2.7 billion annually on smoking-related health conditions. Veterans with serious mental illness (SMI) smoke tobacco products at triple the rate of Veterans without any mental illness and die 10-15 years earlier as a result. SMI Veterans who smoke want to quit and FDA-approved tobacco cessation medications are safe, effective, and readily available in VA. However, mental health providers are hesitant to treat smoking and just 11-18% of Veterans with SMI who smoke receive tobacco medication. External facilitation is an effective implementation strategy that can overcome barriers to integrating evidence-based treatment into routine clinical practice. In collaboration with local and operational partners, the proposed CDA-2 will evaluate and refine an external facilitation strategy to improve tobacco medication prescribing in VA SMI clinics. This proposal aligns with VA priorities to enhance timely access to care and improve Veteran outcomes.

Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer

This clinical trial studies widefield fluorescence and reflectance imaging, fluorescence spectroscopy, and tissue samples in regularly examining (monitoring) participants at risk for developing oral cancer. All tissue and cells are made of tiny particles. Some of these particles give off small amounts of light. This light is called fluorescence. Fluorescent imaging use instruments that shine different wavelengths (colors) of light in the mouth taking fluorescence pictures through a portable head light or by taking fluorescent and reflectance pictures through a dental microscope using a digital camera. Fluorescent spectroscopy uses a small probe placed gently against the lining of the mouth and the tissue is exposed to small amounts of fluorescent light that is then collected with a special camera and a computer to be analyzed. Checking mouth tissue samples under a microscope may also help detect abnormal cells. Diagnostic procedures, such as fluorescence and reflectance imaging, fluorescence spectroscopy imaging, and tissue samples, may help doctors detect pre-cancer or early cancer when it may be easier to treat.

Project Q: Cue-based Treatment Intervention to Promote Cessation Among People Who Smoke Lightly or Non-daily

This study aims to test the feasibility and acceptability of a remotely delivered cue-based treatment intervention to promote smoking cessation among people who smoke lightly or non-daily. Secondary objectives include assessing preliminary efficacy on cessation and examining cue reactivity. Participants will be randomized to CBT only or CBT + cue-based treatment, with assessments at baseline, end-of-treatment, 6 months, and 12 months.