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55 active trials for Nicotine Dependence

Cessation Screening Project

This project will use the Multiphase Optimization Strategy (MOST) to guide the development of optimized treatment strategies for the two most effective smoking cessation medications (Combination Nicotine Replacement [C-NRT] and varenicline). The investigators will recruit daily smokers from primary care to participate in a fully crossed, 2x2x2x2 factorial experiment (N=608) that evaluates 4 different factors: 1) Medication Type (Varenicline vs. C-NRT), 2) Preparation Medication (4 Weeks vs. Standard), 3) Medication Duration (Extended [24 weeks] vs. Standard [12 weeks]); and 4) Counseling (Intensive vs. Minimal). Participants will complete assessments one week pre-quit and then assessments of smoking status, treatment use, side effects, potential treatment mechanisms (e.g., withdrawal, self-efficacy) during the first week post-target quit date (TQD) and at Weeks 2, 4, 12, 20, 26, and 52 post-target quit date. These data will be used to examine the main and interactive effects of these four factors on various outcomes, with biochemically confirmed 12-month abstinence serving as the primary outcome. These data will also be used to determine which factors and combinations of factors are most effective with regard to 12-month biochemically confirmed abstinence and cost, thereby identifying optimized varenicline and C-NRT treatments, with each developed to yield especially great benefit. These optimized treatments will then be tested in the Optimized Care Project. The investigators will also examine the relative effects of each medication on particular outcomes (e.g., 12-month abstinence).

Madison, WisconsinStart: October 2020
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.

Baltimore, MarylandStart: May 2013
Understanding How Cigarette Direct Mail Marketing Influences Smoking Behaviors Among High and Low Socioeconomic Status Young Adult Smokers

Background: Smoking is a major public health problem in the U.S. Almost a half a million Americans die from it in a year. One thing that contributes to why people smoke is the marketing of cigarettes. Cigarette direct mail marketing usually targets young smokers of lower socioeconomic status. Researchers want to find out more about how this kind of marketing influences smoking behavior in young people from different socioeconomic levels. Objectives: To study the effects of cigarette direct mail marketing on beliefs, responses, and arousal. To study how these things may differ among young adult smokers of high and low socioeconomic status. Eligibility: Healthy adults ages 18 to 29 who smoke. Design: Participants will have 1 visit. Participants will be asked questions about their health and recent smoking. A nurse will check their vital signs. Participants will have a simple eye exam. They will give blood and urine samples. Participants will be connected to equipment. This will collect data while they look at pictures. Then they will have a 10-minute break. A nurse will observe them during the break. Participants will have their breath analyzed. Participants will answer questions. The topics will include: Education Job Income Family history Tobacco use Exposure to pro-smoking and anti-smoking messages History of drug and alcohol use

Bethesda, MarylandStart: October 2021
Approach Bias Retraining to Augment Smoking Cessation

Tobacco use is the most preventable cause of disease, disability, and death in the United States. Standard smoking cessation care (cognitive behavioral therapy and nicotine replacement therapy), is effective in approximately 20% of the cases, clearly indicating there is substantial room for improvement. Current work suggests that despite standard interventions, continued substance abuse may result from addictive behaviors governed partly through automatic processes that exert their influence outside conscious control. This is important from a treatment perspective, as we should develop treatments to target implicit processes. Among a number of promising targets for intervention, cognitive biases are important to address as they have been implicated as maintenance factors for addiction. Approach bias, defined as the automatically activated action tendency to approach smoking-related stimuli, is a relatively novel cognitive bias and has been related to failed smoking cessation. A recently developed task for approach bias assessment is the Approach Bias Retraining (ABR), a computerized joystick task increasingly used to measure automatic approach tendencies in addiction research. This clinical trial will evaluate a smoking cessation intervention that integrates standard care with approach bias retraining. Results will provide novel information regarding the potential benefits of engaging implicit cognitive biases as a means to augment traditional smoking cessation therapy. This study has the potential to help individuals attempting to quit smoking and, ultimately, provide unique information about the importance of targeting implicit processes to complement standard care.

Austin, TexasStart: October 2017
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.

Baltimore, MarylandStart: October 2013