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Nicotine Dependence clinical trials

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NCT ID: NCT04571216 Recruiting - Smoking Cessation Clinical Trials

Study Assessing Efficacy and Safety of NFL-101 as a Tobacco Cessation Therapy

CESTO2
Start date: September 1, 2021
Phase: Phase 2
Study type: Interventional

CESTO 2 is a 318 participants, 3-arm, multicentric, randomized, double-blind, placebo-controlled Phase II clinical trial. The main objectives are to select the most efficient dose and to assess long-term efficacy of NFL-101 compared to placebo, for abrupt cessation and for reduction before cessation.

NCT ID: NCT04449510 Recruiting - Nicotine Dependence Clinical Trials

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

TCORS-2
Start date: January 4, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04429568 Recruiting - Nicotine Dependence Clinical Trials

THC Crossover Study

TRDRP
Start date: October 30, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04231539 Recruiting - Nicotine Dependence Clinical Trials

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

Start date: February 18, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04176172 Recruiting - HIV/AIDS Clinical Trials

Optimizing Tobacco Use Treatment for PLWHA

HTO
Start date: February 17, 2020
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT03999099 Recruiting - Nicotine Dependence Clinical Trials

Targeting Orexin to Treat Nicotine Dependence

Start date: September 26, 2019
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT03968900 Recruiting - Smoking Clinical Trials

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

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03904186 Recruiting - Depression Clinical Trials

Effectiveness of an Integrated Treatment to Address Smoking Cessation and Anxiety/ Depression in People Living With HIV

Start date: December 19, 2019
Phase: N/A
Study type: Interventional

Smokers living with HIV represent a major health disparity population in the United States and the world more generally. Major contributing factors to the maintenance and relapse of smoking among smokers living with HIV include increased exposure to multiple stressors associated with HIV, which often exacerbates anxiety/depression. In a previous project, the feasibility, acceptability, and initial efficacy of a 9-session, cognitive-behavioral-based intervention to address smoking cessation by reducing anxiety and depression via specific emotional vulnerabilities (anxiety sensitivity, distress tolerance, and anhedonia) was tested against an enhanced standard of care in a pilot randomized controlled trial (NCT01393301). It was found that when compared to a brief enhanced treatment as usual control, patients in the intervention achieved higher short-term and long-term smoking abstinence rates. In this project, the investigators seek to test this same intervention in a fully powered, 3-arm efficacy/effectiveness trial. The goal of this study is to randomize 180 smokers across three sites to test the efficacy/effectiveness of the intervention at increasing point prevalence abstinence by reducing anxiety and depression at a 1-month follow-up (the end of treatment timepoint/ approximately 1-month post quit day) and a 6-month follow-up (approximately 6-months post quit day).

NCT ID: NCT03506867 Recruiting - Clinical trials for Substance Use Disorders

A Healthy People Initiative: Building the Socio-Economic Capital of Low Income Population At-Risk for HIV and Hepatitis-C

Start date: January 3, 2019
Phase: N/A
Study type: Interventional

"Health is a state of complete physical, mental and social well-being, and not merely the absence of disease or infirmity" (World Health Organization, 1948). Diseases such as HIV/AIDS and Hepatitis-C (HCV) thrive in conditions of poverty and marginalization. Research on the quality of life of people living with HIV/AIDS reveals that unemployed individuals report more depression, anxiety, social isolation, and low self-esteem than employed individuals. Moreover, unemployment is a key factor in the contemplation of suicide among people with HIV/AIDS. Alternatively, employment among people living with HIV/AIDS is a strong indicator of improved quality of life. A finding the study investigators confirmed in a research study (PROMPT) supporting 280 members of Ottawa's low income homeless (or at-risk for homelessness) People Who Use Drugs reduce (and in some cases quit) smoking. PROMPT participants repeatedly stated that boredom and a lack of meaningful social connections and employment were major hindrances in their reduction and overall recovery from smoking and drug use. With these PROMPT findings, the investigators propose a Community-Based Participatory Action project that builds the social capital of 80 participants that identify as members of Ottawa and Toronto's low income People Who Use drugs living with or are at-risk for HIV/AIDS/HCV. The proposed multi-site project will include life-skills training, counseling, health services access (testing and treatment), and education on HIV/AIDS/HCV. Most importantly the project will include a poverty reduction intervention that connects participants with education opportunities, short-term work and volunteer opportunities. The education, work and volunteer opportunities' will be made possible with the support of local business owners and networks that support the study's poverty reduction and community building elements. The aim of project will be to demonstrate the feasibility and cost of a holistic healthcare that encourages a state of complete physical, mental, and social well-being.

NCT ID: NCT03165578 Recruiting - Depression Clinical Trials

Neural Correlates of Neurofeedback Training

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

The objective of the present study is to identify brain networks in patients that contribute to successfully learning self-regulation with real-time fMRI.