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Nicotine Dependence clinical trials

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NCT ID: NCT04047836 Withdrawn - Nicotine Dependence Clinical Trials

Vaping High vs. Low Nicotine E-Liquid

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

This study will examine the effects of electronic cigarette e-liquid nicotine content in a randomized, crossover clinical and behavioral pharmacology study of experienced adult e-cigarette users (N=36). The specific aim is to determine the impact of nicotine content of e-liquid on nicotine pharmacology, systemic exposure to toxic volatile organic compounds, and short-term cardiovascular effects.

NCT ID: NCT03707600 Withdrawn - Nicotine Dependence Clinical Trials

State and Trait Mediated Response to TMS in Substance Use Disorder

Start date: September 27, 2018
Phase: N/A
Study type: Interventional

OBJECTIVES: The current protocol seeks to develop brain-based intermediate phenotypes of response to transcranial magnetic stimulation (TMS) in chronic substance use disorder (SUD). To date the field has relied on subjective reports, behavioral performance, and long-term clinical outcomes as primary measures of TMS efficacy. While certainly ecologically valid, these observable behaviors lack the sensitivity necessary to fully quantify the effects (or lack thereof) across both individual participants and TMS intervention protocols. This proposed within-subjects design seeks to leverage differences in metaplasticity that is, the context in which stimulation occurs-by studying the response to stimulation in both sated and abstinent states. It is predicted these state manipulations will potentiate response to TMS. When a disruptive allostatic load like chronic nicotine exposure or acute abstinence is placed on the brain, the underlying network becomes less stable and thus more susceptible to TMS intervention. For SUD in general and tobacco use disorder (TUD) in particular, this state dependence of TMS response is a potentially valuable tool to improve a given intervention s clinical efficacy. STUDY POPULATION: Physically and psychiatrically healthy smokers will be recruited. A comparison group of non-smokers will be concurrently enrolled. We estimate we will require n=51/group of completers to have sufficient power to develop the intermediate phenotypes of TMS. DESIGN: The protocol is a two group, between/within subject, fully counterbalanced design. The between-subjects factor is GROUP (smoker/non-smoker) and the within-subjects factor for each GROUP is TMS CONDITION (active/sham). Additionally, and for the smoker group, nicotine STATE (sated/abstinent) is a nested within-subjects factor. Each group will receive single sessions of active and sham intermittent theta burst stimulation to left dorsal lateral prefrontal cortex, followed immediately by an MRI scan to characterize the acute neurobiological response to stimulation. Smokers will repeat these procedures both during smoking satiety and following an ~48-hour period nicotine abstinence. OUTCOMES PARAMETERS: In addition to subjective and behavioral task performance changes associated with TMS intervention, changes in MRI BOLD signal will be used to characterize the neurobiological response to TMS intervention across groups and states. Taken together, the development of brain-based markers of TMS response may thus improve both our mechanistic understanding of the causal dysfunctions of TUD as well as the potential efficacy of these interventions longer term to address the relevant clinical characteristics of the disease and ultimately improve treatment outcomes.

NCT ID: NCT03473483 Withdrawn - Nicotine Dependence Clinical Trials

Cigarette Harm Reduction With Electronic Cigarette Use

NIDA-SREC
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03069768 Withdrawn - Nicotine Dependence Clinical Trials

Stage Ib Trial of mSMART With Varenicline

mSMART-v
Start date: April 2018
Phase: Phase 1
Study type: Interventional

The primary aim of this study is to conduct a 60-patient feasibility, acceptability, and preliminary efficacy study of mSMART (Mobile App based Personalized Solutions and Tools for Medication Adherence of Rx Pill), a smartphone application ("app") for improving medication adherence among substance users. The investigators will compare 2 groups of cigarette smokers undergoing a quit attempt with varenicline (Chantix): a) an experimental group using the mSMART app on their smartphone and a MEMS Cap (Medication Event Monitoring System, a smart pillbox that will a record a date and time-stamped medication event whenever pill box is opened and closed, and thus allow for primary measurement of medication adherence) and b) a control group using the MEMS Cap and mobile web-based surveys on their smartphone.

NCT ID: NCT02487953 Withdrawn - Nicotine Dependence Clinical Trials

Electronic Nicotine Delivery Systems as a Smoking Cessation Treatment

ENDS-P50
Start date: July 2018
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to determine whether combining electronic nicotine delivery systems (ENDS) with nicotine patch treatment will augment abstinence rates compared to either treatment alone.

NCT ID: NCT02046551 Withdrawn - Nicotine Dependence Clinical Trials

Atomoxetine's Effects On Nicotine Response And Stress Response In Smokers

Start date: April 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate atomoxetine's effects on the rewarding and reinforcing effects of nicotine in a controlled human laboratory study with 24 otherwise healthy nicotine dependent subjects. It is hypothesized that atomoxetine will attenuate the negative effects of nicotine.

NCT ID: NCT01859364 Withdrawn - Nicotine Dependence Clinical Trials

Tobacco Cessation: Treatment Delivery and Predictors of Outcome

Start date: April 27, 2013
Phase: N/A
Study type: Observational

Background: - The success rate for those who attempt to quit using tobacco products is only about 5 percent. Many people who try to quit do so without seeking professional help. Several kinds of nicotine replacement therapy (NRT) are available without a prescription. However, prescription drugs and mental health counseling can also help people stop using tobacco. Combining NRT and/or medication with counseling can increase success rates. Researchers want to study what kinds of tobacco cessation treatments are most successful. This may help develop better treatments and determine who will respond best to them. Objectives: - To provide treatment for tobacco use. - To identify factors that affect how well people respond to treatment. Eligibility: - Individuals at least 18 years of age who are trying to stop using tobacco products. Design: - This study will last up to 1 year. Treatment may last up to 36 weeks. Treatment may include counseling, NRT (patches and/or nicotine lozenges), or prescription medication (varenicline or bupropion). Treatment will be determined by a study doctor. - Participants will also have three study visits at 4, 6, and 12 months after starting treatment. Each visit may take up to 2 hours. At the study visits, participants will have different kinds of tests. They will provide blood and urine samples, and have carbon monoxide breath tests. They will also fill out forms about mood and tobacco cravings. - During treatment, participants will have clinic visits once or twice a week for counseling and to monitor tobacco use and withdrawal symptoms. Counseling sessions will work on dealing with tobacco cravings. Each visit may take up to 90 minutes.

NCT ID: NCT01784653 Withdrawn - Nicotine Dependence Clinical Trials

Trial of Computerized MET for Adolescent Substance Use

Start date: October 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the effects of a computerized, self-directed Motivational Enhancement Therapy program for adolescent substance use (iMET), in comparison to clinician-delivered MET and Treatment As Usual (TAU), on treatment engagement and substance use. The investigators hypothesize that both iMET and MET will be more effective than TAU in engaging/retaining patients in treatment and in reducing substance use during a 12-month follow-up period. The investigators also hypothesize that Self-directed iMET will be as effective as the clinician-guided MET in increasing treatment engagement and abstinence during the 12-months follow-up period.

NCT ID: NCT01784627 Withdrawn - Nicotine Dependence Clinical Trials

Trial of Computerized SBI to Reduce Teen Alcohol Use

Start date: January 2015
Phase: Phase 1
Study type: Interventional

The goal of this project is to test the effectiveness of a computer-facilitated alcohol screening and brief intervention (c-ASBI) system for 12- to 18-year-old primary care patients in a multi-site, randomized comparative effectiveness trial. The investigators hypothesize that, among 12- to 18-year olds patients coming for annual well-care, those receiving c-ASBI will have lower rates of any alcohol use at 3-, 6-, and 12-month follow-ups compared to Treatment As Usual (TAU).

NCT ID: NCT01784016 Withdrawn - Nicotine Dependence Clinical Trials

Concurrent PET D2/D3 Receptor Imaging and fMRI Smoking Cue Reactivity in Smokers

Start date: January 2014
Phase: Phase 1
Study type: Interventional

This trial aims to determine whether dopamine D3 receptors are elevated in smokers versus nonsmokers and whether correlations exist between D3 receptor binding potential (BP) and functional MRI (fMRI) reactivity to smoking cues, which has been associated with smoking relapse vulnerability. Neuroimaging measures of D3 BP and smoking cue fMRI reactivity will be collected concurrently in otherwise healthy nicotine-dependent smokers and age-matched nonsmokers using a 3 Tesla MRI scanner configured to conduct fMRI and Positron Emission Tomography (PET). We will measure D3 receptor BP using radiolabeled [11C]-(+)-PHNO, which has a relatively higher affinity for D3 versus D2 receptors. We hypothesize that D3 BP will be elevated in smokers versus nonsmokers and that in smokers, there will be a positive correlation between smoking cue fMRI reactivity and D3 BP.