Clinical Research Directory

Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation

This pilot randomized controlled trial will test the feasibility of a smoking cessation intervention using mindful smoking practice and a smartphone-based sensor-band among adults who regularly smoke cigarettes. Participants will be randomized to either an intervention group or a control group. Participants in the intervention group will receive a one-on-one mindful smoking guidance session, instructions for using a smartphone-based sensor-band, a mindfulness practice video, and smoking cessation information. Participants in the control group will receive smoking cessation information. The intervention period will last 8 weeks, with assessments at baseline, 8 weeks, and 4 months after completion of the intervention. The study will evaluate feasibility, preliminary smoking cessation outcomes, and physiologic parameters including heart rate variation, skin temperature, resting heart rate, respiratory rate, and real-time heart rate during craving and mindful smoking practice.

NeuroControl of Nicotine Dependence

The purpose of the study is to examine the effects of continuous theta burst stimulation (cTBS) on different forms of cognitive control in adults who smoke cigarettes, and to determine if the location where cTBS is delivered may help smokers reduce or quit smoking. Participation in the study will take 3-weeks over 4 visits, with a total time commitment of approximately 12 hours.

Adapting and Pilot Testing a Skills-based Smoking Cessation Intervention to Address Developmental and Health-related Stress Among Adults Who Smoke

Smoking remains the leading preventable cause of death in the United States, and there are persistent and significant disparities in tobacco use among transgender and gender diverse (TGD) individuals. Stigma, discrimination, gender dysphoria, and other gender minority stressors likely contribute to these disparities, and the increased burden of gender minority stress may also be driving higher prevalence rates of anxiety and depression, both of which are more common among TGD individuals and among those who smoke relative to comparison samples. This study will (1) explore the ways in which gender minority stressors and associated anxiety and depression compromise smoking cessation among TGD individuals, identifying elements in an existing smoking cessation intervention that need to be adjusted to meet their unique needs; (2) adapt an existing smoking cessation intervention for TGD individuals; and (3) evaluate the feasibility and acceptability of the adapted intervention in a pilot randomized controlled trial.

Cognitive Task Development and Implementation for Functional MRI Studies

Background: * Drugs of abuse have effects on mood, behavior, thinking, and decision making that may encourage people to continue using them and make it difficult for them to stop. Researchers who study these effects are interested in developing new tests to evaluate how drugs and drug use affect different areas of the brain. * Magnetic resonance imaging (MRI) scans allow researchers to study brain activity and changes to brain function. When specific psychological tests are performed during functional MRI (fMRI) scans, researchers can examine the effects of drug use on the brain. By developing and testing new procedures for fMRI studies, more information can be obtained on brain function and activity in drug-using and non-drug-using individuals, and this information can help develop new treatments and therapies for substance abuse. Objectives: \- To develop, assess and refine of cognitive and affective tasks and determination of their practical feasibility and efficacy for both MRI and non-MRI application. Eligibility: * Healthy volunteers between 18 and 65 years of age who are willing to undergo MRI scanning. * Both drug-using and non-drug-using individuals will be selected for this study. Design: * Before the start of the study, participants may complete as assessment of medical and psychological history, and provide information about past or current drug use. Researchers will introduce the tasks to be performed and may have participants practice the tasks. * During the study, participants will be asked to do one or more tasks selected by the researchers. The tasks may be performed on a computer in an MRI machine, and may involve receiving rewards (such as money or sips of juice) for actions, memory and reaction-time tests, or other tests that involve responding to instructions on the screen. * Participants will receive compensation for their participation in the study, including hourly compensation for individual visits.

Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging

Background: \- Functional and structural magnetic resonance imaging (MRI) techniques have allowed researchers to map and study how the brain works when at rest and when engaged in specific tasks. MRI scans have provided more information about how drugs affect the brain, and about how drug addiction changes the brain and influences behavior, mood, and thinking processes. To better understand the underlying mechanism of drug addiction and to develop strategies for more effective treatment, researchers are interested in developing new MRI techniques to study the effects of addiction on the brain. Objectives: \- To develop new functional and structural MRI techniques, and to evaluate their potential use in brain imaging studies related to addiction. Eligibility: * Individuals between 18 and 80 years of age. * Participants may be smokers or nonsmokers, and may use drugs or not use drugs. Design: * During the initial screening, participants will complete questionnaires about family and personal history, drug use, and other information as required by the researchers. Participants who will be asked to complete tasks during the MRI scan will be shown how to perform these tasks before the scanning session. * Before each study session, participants may be asked to complete some or all of the following: questions about their drug use during the last week, a breathalyzer test, a urine drug-use assessment, a urine pregnancy test, or a measure of carbon monoxide. Participants will also provide blood samples before the start of the scan. * For each scanning session, participants will have an MRI scan that will last approximately 2 hours. * MRI scans may include specific tasks to be performed during the scan, or an experiment that studies the brain's response to carbon dioxide.

Effects of Psilocybin on Craving in Nicotine Dependence

This pilot study will examine how a single 25 mg dose of psilocybin affects nicotine craving in people with nicotine dependence. Following psilocybin administration, participants will complete repeated brain imaging (MRI) sessions that mimic the design and procedures of the SCANS (H24-02776) study they previously completed. This will allow us to compare craving and related brain activity before and after psilocybin. We will also explore changes in nicotine use, thoughts about nicotine, motivation to quit, and mental health symptoms. Findings will help inform the design of larger future studies of psilocybin for substance use.

Multimodal Neuroimaging Genetic Biomarkers of Nicotine AddictionSeverity

Background: \- Smoking is a difficult habit to quit, and some people find it more difficult to quit than others do. Nicotine is the substance in cigarettes that makes smoking so addictive. Nicotine changes some patterns of brain activity, and smokers have differences in brain activity when compared to non-smokers. Some genes make it more likely that a person will become addicted to smoking. Researchers want to study how nicotine interacts with genes and brain activity. This may help develop better treatments to help people quit smoking. Objectives: \- To develop a test of nicotine dependence, using brain activity and genetic analysis, which may be useful in predicting success in smoking cessation and in the development of new smoking cessation treatment targets. Eligibility: * Main group: Current smokers between 18 and 55 years of age who are seeking treatment to quit. * Comparison group: Current smokers between 18 and 55 years of age who are not seeking to quit. * Comparison group: Healthy former smokers between 18 and 55 years of age. * Comparison group: Healthy nonsmoking volunteers between 18 and 55 years of age. Design: * Participants will be screened with a physical exam and medical history. Blood samples will be collected. * The three comparison groups will have one magnetic resonance imaging (MRI) scan session. They will have tests of thinking, concentration, and memory both inside the scanner, and while sitting in front of a computer. * Current smokers who are trying to quit must be willing to undergo a course of nicotine treatment that includes weekly counseling (for 12 weeks) and e-cigarettes. Participants will attempt smoking abstinence and will have a total of 6 MRI scanning sessions. They will do thinking, concentration, and memory tasks inside and outside of the scanner. * For smokers, the first scanning session will take place before they attempt to quit. This will be a baseline scan. The second scanning session will take place 48 hours after having their last real cigarette. After this scan, they will use electronic cigarettes to help quit their habit. * After using e-cigarettes for two weeks, smokers will have a third scan session.. They will then gradually taper their use of the electronic cigarettes over the course of three weeks, at which point they will be nicotine abstinent. * After about 5 weeks of abstinence, they will have the fourth scan. The fifth scan will be approximately 6 months after start of the study, and the final scan will take place at about 1 year from the study start. * Smokers will continue to receive support on quitting smoking until the study ends at about 1 year.

Targeting Orexin to Treat Nicotine Dependence

Tobacco smoking continues to be the primary cause of preventable mortality in the United States. Despite the availability of smoking cessation aids, the majority of those trying to quit smoking end up relapsing. Thus, there is a strong need to evaluate alternative treatment targets such as orexin antagonists, which have shown promise in preclinical models at reducing the motivational aspects of drug use.The current work will evaluate the influence of orexin antagonism on several factors impacting the motivation to smoke.

Assess the Influence of Nicotine Flux and Nicotine Form on Subjective Effects Related to Dependency

Electronic nicotine delivery systems (ENDS) heat and vaporize a nicotine-containing liquid to produce an aerosol that can deliver nicotine to the blood and the brain. ENDS use has increased rapidly in the last decade, especially among youth: over 20% of US high school students are current ENDS users, and there is evidence of nicotine dependence in this population. Federal legislation has been proposed that would restrict ENDS liquid nicotine concentration to make ENDS "significantly less addictive and appealing to youth." However, these and other efforts to curb addiction by limiting nicotine liquid concentration are unlikely to succeed because nicotine emissions from ENDS depend on multiple variables. To achieve the intended public health aims, regulations targeting addiction must focus on nicotine delivery, not nicotine concentration. While nicotine delivery cannot be regulated directly, the rate at which an ENDS emits nicotine, the "nicotine flux", can be regulated and, importantly, predicted based on a few device design and operating variables. However, to date there is no empirical evidence demonstrating the relationship between flux and delivery, nor between flux and the subjective effects that support nicotine dependence. Closing this gap is essential for providing an effective framework for regulating ENDS. At the American University of Beirut, the investigators will assess the relationship between nicotine flux, form, and subjective effects. Participants will use ENDS devices with varying nicotine fluxes and forms. Dependency measures, such as urge to smoke, craving, and abstinence, will be assessed. The outcome will indicate the degree to which nicotine flux/form influence subjective effects related to dependency, puffing intensity, and exposure to toxicants. In summary, this project will provide the empirical evidence needed for public health agencies to use nicotine flux as an encompassing and convenient construct to regulate nicotine delivery from ENDS.

Varenicline and Accelerated Transcranial Magnetic Stimulation (TMS) for Quitting Nicotine Use (Pilot Study)

The goal of this clinical trial is to learn if a combination of varenicline and enhanced accelerated Transcranial Magnetic Stimulation (aTMS) works to help adults quit using nicotine products. Researchers will compare varenicline + active aTMS with a single dose of D-Clycloserine to varenicline + sham (inactive) aTMS with a placebo pill to see the effect of enhanced aTMS on reaching abstinence. The main question it aims to answer is: Does receiving active enhanced aTMS + varenicline lead to higher abstinence rates and lower nicotine craving? Participants will be asked to: * Complete 2 brain MRI scans * Take varenicline every day for 12 weeks * Quit using nicotine products at the end of the second week of varenicline * Complete one day of up to 20 TMS treatments * Take a single dose of D-Cycloserine medication on the day of TMS treatment * Complete 12 brief, weekly study visits * Complete 6 brief, monthly follow up visits * Complete a brief daily survey each day that they take the study drug

Orexin s Role in the Neurobiology of Substance Use Disorder

Study Description: Despite the availability of pharmacotherapy for some substance use disorders, relapse vulnerability is still a significant issue. This suggests medications with alternative mechanisms of action should be explored to address this unmet need. Substantial preclinical research indicates that orexin antagonism blunts the internally and externally triggered motivation to attain abused substances. This research project will translate these preclinical findings into the clinical domain by administering the FDA approved orexin antagonist, suvorexant, to those with a substance use disorder. Suvorexant s ability to blunt neurobiological correlates of substance misuse will be assessed. This will be assessed following acute and repeated drug administration. Baseline individual differences will be considered to determine whether neurobiological variance influences suvorexant s impact in those with nicotine dependence. In an independent arm, the interaction between suvorexant and a dopamine agonist (methylphenidate) on cognitive function will be assessed in non-smoking individuals. Objectives: The objective is to determine the acute and chronic impact of the orexin antagonist, suvorexant, on neurobiological and behavioral factors linked with substance use disorders. Whether such effects are mediated by baseline characteristics will be tested. Given suvorexant is an FDA approved treatment for insomnia, sleep will be evaluated as well in the nicotine dependent arm. Endpoints: In nicotine-dependent individuals, suvorexant s impact on brain function will be assessed several ways by evaluating: 1) resting function, 2) reactivity to drug cues, 3) reactivity to non-drug related cognitive tasks. Sleep and nicotine use will be measured throughout the study period. In those without nicotine-dependence, the impact of suvorexant and the interaction of acute methylphenidate and suvorexant on brain function will be assessed. This arm will provide insight into how suvorexant impacts reward/cognition as well as impacts the pharmacological influence of methylphenidate on those same measures. Study Population:\<TAB\> Nicotine dependence arm:140 subjects; Volunteers who are between the ages of 18-60 and are daily smokers/vapers. Control arm: 80 subjects; Volunteers who are between the ages of 18-60 and are non-smokers/vapers This study will be conducted at the NIDA-IRP, Biomedical Research Center, in Baltimore, MD. Description of Study Intervention: Nicotine dependence arm: Suvorexant at 10 mg single dose, and Suvorexant at 10 mg daily for approximately 7 days. Control arm: 1. Tolerability visit with one MRI scan post-20mg methylphenidate, 4 acute drug administration (6-14 days in randomized order: 1. Placebo + placebo; 2. 20mg suvorexant + Placebo; 3. Placebo + 40mg methylphenidate; 4. 20 mg suvorexant + 40mg methylphenidate max) Study Duration: 5 years Participant Duration: 1-2 months

Overcoming Nicotine Dependence to Enable Quitting

Tobacco use disorder is a chronic, relapsing health condition that necessitates a chronic care approach. However, traditional smoking cessation treatment programs allocate nearly all their resources only to those smokers who are willing to set a quit date. This is problematic because few smokers are ready to set a quit date at any given time, and a smoker's stated intention to quit can change rapidly. One novel potential treatment strategy is to foster practice quitting (PQ), defined as attempting to not smoke for a few hours or days, without pressure or expectation to permanently quit. Although a growing body of evidence supports the role of practice quitting in fostering permanent quit attempts and cessation, there is a significant knowledge gap regarding which treatment strategies should be used to engage smokers in practice quitting. The proposed study will test the role of PQ counseling vs. Motivational Interviewing (MI) counseling, and NRT sampling (four-week supply of nicotine lozenges and patches) vs. none.

A Digital Intervention (ACT on Vaping App) for Vaping Cessation in Young Adult E-Cigarette Users

This clinical trial evaluates a smartphone application (app) called Acceptance and Commitment Therapy (ACT) on Vaping for helping young adults quit using electronic cigarettes (e-cigarettes). E-cigarettes pose numerous risks, particularly to youth and young adults. Addressing the high prevalence of e-cigarette use by young adults requires effective and accessible treatments to support current users to quit. Research shows this group prefers and benefits from newer methods of treatment delivery such as digital interventions. ACT on Vaping is a digital therapeutic intended to deliver behavioral therapy to young adults who vape to motivate and support abstinence from all nicotine and tobacco products. The app contains sessions that promote awareness of cues that trigger tobacco use and teach skills for responding to these triggers in a way that is tailored for the participant's readiness to quit. Receiving access to the ACT on Vaping app may be effective in helping young adults quit vaping.

Optimizing Tobacco Use Treatment for PLWHA

The advent of anti-retroviral therapy (ART) for people living with HIV/AIDS (PLWHA) substantially improved life expectancy but has also led to the critical need to address modifiable risk factors associated with cancer and cardiovascular disease, such as tobacco smoking. HIV-infected smokers lose more life-years due to tobacco use than they do to their HIV infection. There have been relatively few studies of tobacco use treatments for PLWHA and systematic reviews show that there are insufficient data to conclude that tobacco dependence interventions that are efficacious in the general population are efficacious for PLWHA. Further, many studies in this area have lacked randomization and a control group, infrequently used an intent-to-treat (ITT) approach and biological verification of tobacco abstinence, and lacked post-treatment follow-up.10 What investigators do know thus far is that behavioral interventions and the nicotine patch yield moderate effects on cessation; and 2 recent placebo-controlled trials - one in France and one by this lab - found that varenicline is safe and effective for treating tobacco use among PLWHA, but yield quit rates that are substantially lower than those reported in the general population. Thus, there is a critical need to rigorously test novel ways to optimize tobacco cessation treatment for smokers with HIV.

Sex Differences in E-Cigarette Perception

This study examines differences between males and females in the appeal and addiction potential of menthol flavored e-cigarettes with and without nicotine.

Racial Differences in Circadian and Sleep Mechanisms for Nicotine Dependence, Craving, and Withdrawal

The number one preventable cause of death in the world is tobacco use. Cigarette smoking in particular, costs an estimated $300 billion due to expenses related to medical care and lost productivity. Despite similar smoking prevalence rates, blacks suffer disproportionately from smoking-related harms compared to whites.Sleep disparities such as shortened sleep duration, shorter circadian periodicity, earlier chronotype, and increased variability of sleep timing have been reported more frequently in blacks compared to whites. Given that poor sleep quality predicts relapse from smoking cessation programs, particularly among socioeconomically disadvantaged adults, sleep deficiencies and irregular timing of sleep may impact smoking craving and withdrawal symptoms over the course of the 24-hour day. Surprisingly, few studies have examined these temporal patterns of smoking and craving, and none with regard to sleep disruption, chronotype or racial disparities. A better understanding of these factors may explain heterogeneity within the smoking population, especially in minorities. Thus, the purpose of this proposal is to test the central hypothesis that the impact of chronotype and impaired sleep on cigarette usage as well as smoking dependence, urge/craving, and withdrawal depends on race.

Methadone-Maintained Smokers Switching to E-Cigarettes

Participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ECs). There will be a total of 7 study visits over the course of 6 weeks; each visit includes psychometric assessment and biomarker measurements. After completion of the baseline visit, participants will be randomized to either: 1) 6 weeks of EC use (JUUL 5% nicotine pods) or 2) 6 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges. EC and NRT use will begin the day after the baseline assessment.

Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches

Tobacco-free oral nicotine pouches (such as Zyn brand) are a less harmful alternative to cigarette smoking. Pouches, however, contain nicotine, and addictive substance that is not risk-free. The present study is evaluating how well nicotine pouches, at different nicotine levels, help people switch away from smoking cigarettes. People who smoke cigarettes will be asked to answer questions about their tobacco product use and provide breath samples and cheek swab samples at an in-person visit to MUSC Charleston. Participants will then be provided with a 28-day supply of nicotine pouches, and will be asked to switch from smoking to pouches over the course of 4 weeks. Finally, participants will complete a final visit at MUSC, and will answer more questions about their tobacco use 1-month later.

A Patient-Oriented Research Mentoring Program in Tobacco Dependence and Implementation Science Research

The objective of this trial is to evaluate the effectiveness of "nudges" to clinicians, patients, or both in increasing referral to, and engagement with, tobacco use treatment services (TUTS) for HIV patients versus usual care. This will be a four-arm pragmatic cluster randomized clinical trial. The investigators hypothesize that each of the implementation strategy arms will significantly increase TUTS referral and engagement compared to usual care and that the combination of nudges to clinicians and to patients will be the most effective.

Effects of Very Low Nicotine Content Cigarettes Among Adults Who Smoke Daily in South Korea

The goal of this clinical trial is to learn how switching to very low nicotine content (VLNC) cigarettes affects smoking behavior and nicotine exposure among adults in South Korea who smoke conventional cigarettes daily. The main questions it aims to answer are: * Do participants assigned to VLNC cigarettes smoke fewer cigarettes per day during the 7 days before the Week 14 endline visit than those assigned to normal nicotine content (NNC) cigarettes? * Do participants assigned to VLNC cigarettes have more smoke-free days during the 12-week randomized intervention period than those assigned to NNC cigarettes? Researchers will compare participants assigned to VLNC cigarettes with those assigned to NNC cigarettes to evaluate differences in smoking behavior, nicotine exposure, dependence, craving, withdrawal symptoms, abstinence-related outcomes, use of other tobacco or nicotine products, product perceptions, policy support, and behavioral patterns assessed using ecological momentary assessment. Participants will: * Complete a 1-week baseline period while continuing to smoke their usual-brand cigarettes. * Be randomly assigned to receive either VLNC or NNC SPECTRUM research cigarettes for 12 weeks. * Attend scheduled study visits and complete questionnaires, daily surveys, and ecological momentary assessments. * Provide urine samples for assessment of nicotine exposure and complete other study assessments related to smoking behavior and symptoms. Up to approximately 350 individuals may be recruited and screened to obtain approximately 300 randomized participants.

Effects of Cannabidiol on Stress and Nicotine Withdrawal

The purpose of this study is to examine the effect of doses of cannabidiol (CBD) during exposure to stress and nicotine withdrawal in nicotine users. The main objectives of the study include examining the effect CBD has on stress, tobacco dependence, tobacco withdrawal, and sex differences between these types of stress. Participants will be administered CBD and exposed to stress. Biological and subjective measures will be collected. Participants may be asked to stop use for 24 hours. Researchers will also investigate withdrawal effects between participants who have not smoked nicotine in 24 hours and those who have continued to smoke before each session.

Effect of Teleconsultation Counseling on Smoking Cessation

This randomized controlled trial conducted at Dokuz Eylül University evaluated whether video teleconsultations are as effective as traditional face-to-face clinic visits for helping people quit smoking * Over a 6-month period, the study found that while overall quit rates were statistically similar between the two groups, patients receiving teleconsultation support experienced significantly fewer cigarette cravings and fewer relapses * Teleconsultation also solved a common problem in smoking cessation: patients missing their follow-up appointments due to travel or time constraints

Puff Topography and Sensory Effects Across IQOS Device Generations

The goal of this clinical trial is to learn how people use two generations of IQOS heated tobacco devices and how each device affects their smoking behavior and sensory experience. The main questions it aims to answer are: * Do participants puff differently when using the newer IQOS Iluma i compared to the older IQOS 2.4? * Does the flavor of the tobacco stick (preferred flavor vs. standard tobacco flavor) affect puffing behavior or sensory experience? * What are the differences in throat hit, mouthfeel, and satisfaction between the two devices? Participants will: * Attend 2 laboratory visits at the American University of Beirut * Use both the IQOS Iluma i and IQOS 2.4 devices during each visit * Have their puffing behavior recorded automatically during device use * Provide a breath sample before and after each use session * Complete short questionnaires about how each device felt and their urge to smoke

Social Media Support Groups for Adolescent Vaping Cessation

The purpose of this study is to pilot test feasibility and acceptability of the Quit the Hit Toolkit, a social media-based nicotine vaping cessation program for adolescents and young adults, adapted for use in community settings.