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54 active trials for Nicotine Dependence

Smoking Cessation for People Living With HIV/AIDS

In this proposed study with People Living with HIV/AIDS (PLWHA), we will use a stepped care model called a Sequential Multiple Assignment Randomized Trial (SMART) to examine the efficacy of low- and high-intensity smoking cessation treatments for nicotine dependent PLWHA that incorporate the current standard of care and prize-based contingency management. Intervention will be administered in a community-based HIV integrated care clinic in downtown Detroit, which has the highest prevalence rates of HIV/AIDS and smoking in Michigan. Phase 1 will last 4 weeks, and will involve brief intervention to help participants stop smoking. For phase 2, participants will be assigned to different study arms depending on whether they are Responders (reduced their smoking) or Non-responders (continued to smoke). Phase 1: We hypothesize that brief high-magnitude prize contingency management will result in greater reduction in smoking than standard of care alone. Phase 2a: We hypothesize that non-responders who are assigned to contingency management will be more likely to reduce their smoking throughout treatment and to abstain from smoking at all follow-up points. Phase 2b: We hypothesize that responders who are assigned to monitoring and low-magnitude prize contingency management will be more likely to maintain their reduced or abstinent smoking status at all follow-up time-points.

Start: August 2013

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.

Start: November 2013

Nicotine Withdrawal Symptoms and Smoking Relapse

Background: - Smoking is thought to cause changes in the brain that lead to addiction and craving. Smokers who try to quit experience nicotine withdrawal symptoms that include irritability, anxiety, and difficulty concentrating. These symptoms make it difficult for people to stop smoking. Many people say that they continue smoking to help relieve these symptoms, often within the first week after trying to quit. Researchers want to study what is happening in the brain to cause these symptoms, which may help identify new ways to successfully quit smoking. Objectives: - To study nicotine withdrawal symptoms and brain function in smokers who stop smoking for 36 hours. Eligibility: - Individuals between 18 and 65 years of age who smoke at least 10 cigarettes per day. Participants must be able to stop smoking for 36 hours on two occasions. Design: Phase 1 This study will involve three visits to the National Institute on Drug Abuse. NOT be able to smoke for 36 hours before the two imaging visits. Wear a nicotine skin patch or a placebo (fake) patch during your 36 hour smoking abstinence period and study visits. Have your blood drawn to test for levels of stress-related hormones. Complete multiple MRI scanning sessions that last about 1.5 to 2 hours each. Undergo EEG (brain waves) recording. Answer questionnaires about how you think and feel. Complete various tasks and procedures inside and outside of the MRI scanner. Phase 2 This study will involve thirteen visits to the National Institute on Drug Abuse. Set a quit date and develop a treatment plan with a study therapist. Take Chantix (varenicline) every day for a period of 12 weeks. Meet for weekly and biweekly counseling sessions with a therapist. Answer questionnaires about how you think and feel. Phase 3 This study will involve three visits to the National Institute on Drug Abuse. Complete an MRI scanning session that will last about 20min each visit Meet with a study staff member on each visit who will ask you questions about your smoking behavior and how you think and feel....

Start: May 2013

The Interaction of Flavor With Nicotine Form in Adult Smokers

This study seeks to elucidate the impact of e-cigarette flavor on subjective effects and nicotine exposure from e-cigarettes containing different forms of nicotine.

Start: November 2020

Personalized Dosing of Nicotine Replacement (NRT to Effect)

Medications for smoking cessation are currently only effective in helping a minority of smokers quit. Drug development is slow and expensive, so there is much interest in optimizing the effectiveness of existing treatments and medications. Current standard doses of nicotine replacement therapy (NRT) are not effective for many smokers and in many cases provide less nicotine compared to when a smoker is smoking their usual number of cigarettes. The proposed study will test if a personalized dose of nicotine patch (up to 84mg) will improve quitting success in those who do not respond to a standard dose of NRT (21mg).

Start: January 2018

Short-Term Cardiovascular Effects of E-Cigarettes: Influence of E-Liquid pH

This study will examine the short-term cardiovascular (CV) effects of e-liquid pH in a randomized, crossover clinical and behavioral pharmacology study of experienced adult e-cigarette users (N=21). The specific aim of the study is to assess the impact of changes in e-liquid pH on nicotine pharmacokinetics, cardiovascular, and subjective effects of e-cigarettes.

Start: January 2021

The Role of Nicotine and Non-Nicotine Alkaloids in E-Cigarette Use and Dependence

The advent of electronic cigarette (e-cigarette) technologies represents one of the most significant developments in the last several decades, and provides a novel and promising strategy for substantially reducing the morbidity and mortality associated with smoking. However, serious concerns have been raised regarding the possibility that e-cigarettes will sustain a dependency on nicotine and that they may lead to continued use of conventional cigarettes known to be extremely harmful to health. Cigarette addiction critically involves a dependence on nicotine, but it is likely that other tobacco constituents contribute to dependence as well. Recent evidence suggests that non-nicotine tobacco alkaloids, or NNTAs (including anabasine, anatabine, nornicotine, and myosmine) may play a role in tobacco dependence. These alkaloids have been shown to augment the reinforcing effects of nicotine in animal models and to affect cravings in human smokers. E-cigarettes contain variable quantities of nicotine and NNTAs, but there is virtually no information available concerning the role of e-cigarette nicotine or NNTA content in influencing the concurrent use of cigarettes and e-cigarettes, when smokers attempt to switch from conventional combustible cigarettes to e-cigarettes. Additionally, it is not known whether the presence of nicotine and NNTAs in e- cigarettes may sustain dependence, making it difficult to relinquish these products. The proposed project will assess the acceptability, extent of switching behavior, and degree of dependence maintained when smokers are provided with e-cigarettes containing nicotine and NNTAs.

Start: May 2021

Helping Poor Smokers Quit

Using a 2x2 randomized factorial design, we will conduct a statewide field trial in Missouri to compare the relative and combined effects of these two strategies for augmenting an existing, evidence-based tobacco quitline program. Among 2000 low-income smokers, half will receive standard Missouri quitline services and half will receive new Specialized Quitline services targeted to this group. In each of these groups, half also will receive calls from a trained navigator to help them address unmet Basic Needs and the accompanying psychological distress that act as barriers to smoking cessation.

Start: June 2017

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.

Start: January 2021

Improving Tobacco Treatment Rates for Outpatient Cancer Patients Who Smoke

The main purpose of this research study is to evaluate the effectiveness of "nudges" to clinicians, to patients, or to both in increasing Tobacco Use Treatment Service (TUTS) referral and engagement; and to explore clinician, patient, inner setting (e.g., clinic), and outer setting (e.g., payment structures) mechanisms related to TUTS referral and engagement. The investigators will employ rapid-cycle approaches to optimize the framing of nudges to clinicians and patients prior to initiating the trial and mixed methods to explore contextual factors and mechanisms. The investigators will conduct a four-arm pragmatic cluster randomize clinical trial to test the effectiveness of nudges to clinicians, nudges to patients, or nudges to both in increasing TUTS referral and engagement in cancer patients who smoke, vs. usual care (UC). The investigators hypothesize that each of the implementation strategy arms will significantly increase TUTS referral and engagement compared to UC and that the combination of nudges to clinicians and to patients will be the most effective.

Start: May 2021

Cigarette Harm Reduction With Electronic Cigarette Use

This is an observational, crossover study that will be examine use behaviors, chemical exposures, and biological effects of SREC compared to TC use in subjects confined to a research ward setting.

Start: August 2021

Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation

The proposed study represents a crucial and important stage in translating basic research to strategies for treating nicotine dependence. The investigation addresses an important public health issue by testing an intervention - informed by basic research - that may lead to a more effective and efficient treatment for smokers. The expected findings should provide initial effect size data for the addition of isradipine to an integrated psychosocial/behavioral and pharmacological smoking cessation intervention for smokers, and thus provide the necessary data for a large-scale follow-up trial.

Start: January 2020

Pharmacokinetics, Subjective Effects, and Abuse Liability of Nicotine Salt-Based Vaping Products With Tobacco or Unflavored E-liquids, SALTVAPE Study

This trial studies activity of time (pharmacokinetics), subjective effects, and abuse liability of nicotine salt-based vaping products with tobacco or e-liquids. This study aims to determine and compare the levels of nicotine delivered to the bloodstream from nicotine salt and free-base nicotine e-liquid solutions.

Start: February 2020

Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace

This project will examine the impact of very low nicotine content (VLNC) cigarettes in a complex tobacco and nicotine product marketplace. We will compare the number of cigarettes smoked and cigarette-free days in an experimental marketplace that contains VLNC cigarettes versus normal nicotine content (NNC) cigarettes.

Start: June 2018

Improving Tobacco Treatment Rates for Cancer Patients Who Smoke

The research objective is to identify a simple, pragmatic, innovative way of enhancing Tobacco Use Treatment (TUT) rates within oncology. To investigate this possibility, the investigators propose methods that will allow them to: 1) evaluate the impact of standing orders to initiate a varenicline management protocol within outpatient cancer treatment workflow, 2) assess the potential for an EHR-based intervention to affect patient TUT behaviors, and 3) identify important facilitators and barriers that impact effectiveness of the intervention. The investigators will assess whether including a standing order for prescription and management of varenicline (TUT Service+VM) within the workflow for cancer patients identified as current smokers will significantly increase TUT engagement rates compared to current standard of care (TUT Service alone). The investigators hypothesize that observed treatment engagement rates will be higher among clinicians exposed to TUT Service+VM than observed in clinicians exposed to TUT Service alone.

Start: June 2021

QuitFast: Evaluating Transcranial Magnetic Stimulation as a Tool to Reduce Smoking Directly Following a Quit Attempt

Cigarette smoking constitutes the greatest preventable cause of mortality and morbidity in the US. The most critical period for long term success of smoking cessation appears to be in the first 7 days after the quit date. A metaanalysis of 3 pharmacotherapy trials revealed that abstinence during the first 7 days was the strongest predictor of 6 month outcomes (n=1649; Odds ratio: 1.4, P <0.0001; Ashare et al. 2013). Prodigious relapse rates during this first week of smoking cessation are likely due to behavioral and neurobiological factors that contribute to high cue-associated craving and low executive control over smoking. The long term goal of the research is to develop evidence-based transcranial magnetic stimulation protocols to facilitate abstinence during this critical period.

Start: August 2020

Clinical Learning Study for a Mobile Smoking Cessation Program

The purpose of this study are to obtain learnings regarding the Digital Therapeutic (DTx) experience of Clickotine, including acceptability and preference of the overall program and specific DTx components, as well as to obtain learnings related to adult participants' use of the DTx for smoking cessation.

Start: March 2021

Short-Term Cardiovascular Effects of E-Cigarettes: Influence of Device Power

This study will examine the short-term cardiovascular (CV) effects of e-cigarette device power in a randomized, crossover clinical and behavioral pharmacology study of experienced adult e-cigarette users (N=21). The specific aim is to determine the impact of e-cigarette power on nicotine pharmacology, systemic exposure to toxic volatile organic compounds (VOCs), and short-term cardiovascular effects.

Start: March 2019

Pharmacokinetics and Pharmacodynamics of Different Nicotine Salt Concentration Vape System Pods and Free-base Nicotine

Comparison of the pharmacokinetics and pharmacodynamics of two different nicotine salt concentrations and free-base nicotine using an open vape pod system

Start: September 2021

THC Crossover Study

This is a randomized, crossover study enrolling experienced dual cannabis-tobacco smokers (N=18) to describe the differences in THC and toxicant exposure, examining pharmacokinetic, subjective, and cardiovascular effects from smoking and vaping dry herb cannabis. This study will also examine the differences in toxicant exposure and cardiovascular disease risk between smoking cannabis and smoking tobacco cigarettes.

Start: October 2020