View clinical trials related to Tobacco Use Disorder.
Filter by:In this between-subjects, placebo controlled, double-blind study, the investigators will examine the effects of low oral doses of nicotine on the learning and extinction of a conditioned place preference acquired in a virtual reality environment by healthy human subjects. Physiological and subjective responses to the drug will also be monitored.
This study is evaluating the efficacy of Treatment A for short-term smoking cessation through a blinded randomized controlled trial (RCT) vs.Treatment B.
This phase I trial will use a pilot sequential multiple assignment randomized trial (SMART) to examine protocol feasibility and acceptability of new components of a web-based intervention for socially anxious smokers. This study will be used to help build an adaptive treatment strategy to improve engagement with and effectiveness of the web-based intervention. Adaptive treatment strategies provide individualized sequences of intervention components to accommodate the changing needs of individuals based on their characteristics, treatment response, or engagement.
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.
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.
Tobacco smokers with schizophrenia are known to be resistant smokers, with high rates of smoking and inability to quit in the long-term, often related to smoking relapse. This may relate to problems with frontal lobe function associated with schizophrenia, which make these patients have great difficulty in dealing with smoking withdrawal, urges and cravings. The current study will develop a combination approach that takes advantage of brain stimulation of the frontal lobes (repetitive transcranial magnetic stimulation (rTMS), in combination with the anti-smoking drug varenicline, to prevent smoking lapse using a well-established human laboratory method. Results from this study may have important implications for developing novel treatment approaches for smokers with schizophrenia.
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.
Almost 12% of women report smoking during pregnancy. Smoking during pregnancy is associated with adverse fetal outcomes and up to 35-75% of women quit smoking during their pregnancy. Clinical trials of tobacco cessation medications have reported safety concerns along with limited efficacy. Subsequently, these medications are not generally recommended in pregnancy and most women who stop smoking do so unassisted. Not surprisingly, the rates of smoking relapse in the post-partum period are up to 67%. To date, clinical trials of behavior interventions in the post-partum period have been largely null. Pharmacotherapy has not been studied as a means of preventing relapse in smokers who quit without the use of medications. Additionally, these medications are excreted in breast milk, which limits there use for lactating women. Thus alternative, safe, and effective strategies to prevent smoking relapse in high-risk, former smokers during the post-partum period are needed. n-3 long-chain polyunsaturated fatty acids (LCPUFA) have anti-inflammatory properties and appear effective as adjuvant therapy for depression. In animal models, n-3 LCPUFA deficiencies can result in hypofunctioning of the dopamine mesocorticolimbic pathways which are related to reward and dependence. Nicotine results in an elevation of dopamine in the nucleus accumbens which is associated with the pleasurable sensations related to nicotine use. It has been hypothesized that correcting the hypofunctioning dopaminergic system through n-3 LCPUFA supplementation might reduce nicotine cravings. Taken together, these studies suggest that supplemental n-3 LCPUFA might be useful in preventing smoking relapse. The investigators' hypothesis is that post-partum former smokers randomized to n-3 LCPUFA supplementation will be less likely to relapse and have less nicotine cravings compared to women allocated to placebo. To test this hypothesis they will conduct a 12-week, randomized, double-blind, placebo controlled study of 4 grams/day n-3 LCPUFA supplementation versus placebo. Participants will be enrolled prior to hospital discharge. The primary outcomes of the trial will be time to smoking relapse and change in self-reported nicotine cravings. The secondary outcome will be point prevalence abstinence at 6- and 12-weeks. compliance will be monitored by measuring red blood cell phospholipid fatty acid content and verify smoking cessation through end-expired CO and cotinine.
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.
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.