Active clinical trials for "Tobacco Use Disorder"

Cocaine addiction continues to be an important public health problem in the US with a significant cost to the individual and society. Among substance abusers, cocaine use has been recognized as a significant problem especially in methadone-maintenance patients. In several studies, rates of cocaine use have been reported to range from 30 to over 60 percent of those in methadone maintenance programs (Condelli et al. 1991; Hunt et al. 1984; Kidorf and Stitzer 1993; Kosten et al. 1988). In these patients, cocaine use seems to be a predictor of poor clinical outcome (Hartel et al. 1995; Kosten et al. 1987a). The development of effective pharmacotherapies for cocaine use disorders, especially in the opioid-dependent population is of great importance. Unfortunately, such effective pharmacotherapies do not exist. To determine the safety and tolerability of varenicline in cocaine-using methadone-stabilized subjects. To determine if varenicline is efficacious in reducing cocaine-use in methadone-stabilized subjects.

Recent research on the effects of nicotine on the brain and behavior presents an opportunity to advance medication development. The purpose of this study is to develop a laboratory model for early-stage testing of new and existing treatments for nicotine addiction. Specifically, the investigators will develop a laboratory model of relapse to cigarette use in nicotine dependent volunteers.

In Qatar, tobacco use is one of the main causes of premature deaths and preventable diseases. As per the 2013 Global Adult Tobacco Survey (GATS), 12.1% of adults and 20.2% of men in Qatar smoke tobacco, and 55.4% of this smoke an average of 16 cigarettes or more per day. Moreover, 15.7% of school students aged 13 to 15 years currently use some form of tobacco according to the 2013 Global Youth Tobacco Survey (GYTS). In Qatar, tobacco-related diseases including cardiovascular diseases and cancers are highly prevalent. In an effort to reduce tobacco use, Qatar has ratified the WHO Framework Convention on Tobacco Control (FCTC) and has implemented many tobacco control initiatives. In spite of these measures, tobacco use is still rising in Qatar. Pharmacists practicing in retail/community pharmacy are often the first port of call for individuals requiring health advice in general. Evidence has proven that they have a pivotal role in health promotion and disease prevention including tobacco cessation. Hence, pharmacists have excellent opportunities to reduce tobacco use in Qatar. Yet, ambulatory and community pharmacists in Qatar are not sufficiently contributing to tobacco control. Based on published data, only 21% of community pharmacists in Qatar always or most of the time ask patients about their smoking status. Furthermore, when asked about their smoking cessation training, 89% of pharmacists did not receive any kind of education or training about smoking cessation counseling in the past. In an effort to build the capacity of pharmacists in Qatar, the aim of the proposed study is to design, implement and evaluate an intensive education program on tobacco treatment for pharmacists in Qatar. The study will be a prospective randomized controlled trial comparing the effectiveness of the education program on pharmacists' tobacco cessation-related knowledge, attitudes, self-efficacy, and skills.

The goal of this research is to understand the potential impact of two new FDA strategies to ensure the availability of safer Alternative Nicotine Delivery Systems (ANDS) and to reduce the nicotine content in combustible cigarettes to non-addictive levels. Specifically, this research will examine how well ANDS and very low nicotine cigarettes (VLNCs) can work alone or in combination with the current strategy of providing a safe source of nicotine via nicotine replacement medications to reduce use of combustible cigarettes, in real-world settings. The investigators will enroll 180 daily adult smokers who are not planning to quit smoking within the next 30 days into this mixed design study. Participants will be randomly assigned to one of three levels of the between-subjects factor: 1) VLNC cigarettes; 2) Juul e-cigarettes (with nicotine); or 3) no alternative product. Participants receiving an alternative product (VLNC or e-cigarettes) will be asked to use it for 4 weeks (Weeks 1 through 4). During Weeks 2 and 4 all participants will be asked to switch from their cigarettes to use only study products (i.e., Juul e-cigarettes, VLNCs, or no alternative product) and to use either an active nicotine or placebo patch (the within-subjects factor), provided in double-blind fashion and counterbalanced order. During Weeks 1 through 4, participants will use a smartphone to record, in the moment, each time they use their own cigarettes or any alternative product. For a random daily subset of use events, participants will complete additional questions about the internal and external context of their use (e.g., affect, any restrictions on smoking) and their response to use (e.g., withdrawal alleviation, taste, satisfaction). Using these data, the investigators will also examine the effects of these products on the rewarding value of smoking and possible mechanisms driving such behavior (e.g., withdrawal alleviation, satisfaction, taste). This research will provide critical information regarding the potential impact of providing cigarettes with non-addictive levels of nicotine and safe ANDS, with or without nicotine replacement, in real-world settings on smokers' use of their usual cigarettes and other outcomes. Information on the short-term effects of products that could be accessible in the future will provide data that could inform regulatory policy decisions regarding the public health impact of safe ANDS and non-addictive cigarettes.

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.

This study is an examination of the influence of sweet and cooling flavors on the appeal and abuse potential of nicotine-containing e-cigarettes among susceptible youth.

In a double-blinded, randomized, parallel controlled design, patients with schizophrenia spectrum disorder will be exposed to active or sham repetitive transcranial magentic stimulation (TMS) which was guided by functional magnetic resonance image (MRI). Smoking reduction/cessation and brain functional connectivity changes will be assessed at baseline, different stages of rTMS and/or follow-ups.

The FDA has concluded that flavors (e.g. menthol) are associated with greater addiction potential in tobacco cigarettes (Gottlieb March 13, 2019). Whether the same is true for e-cigarettes and non-menthol flavors is unclear and our study should help answer this question. Our major hypothesis is that the pharmacological effect of nicotine to induce addiction will be greater with use of a preferred e-cigarette flavor than with use of a non-preferred flavor. The pharmacological effect will be measured by how much a larger nicotine dose increases addiction potential compared to a smaller dose.

This is a pilot randomized controlled trial (RCT) with the overarching aim of testing the influence of reducing electronic nicotine delivery system (ENDS) use or nicotine on addiction and combustible cigarette (CC) smoking among dual users. Specifically, the investigators will conduct a 4-week pilot RCT in which dual users who are not motivated to quit either product in the near future are randomized to A) abruptly switch to low nicotine ENDS pods, B) abruptly reduce number of usual nicotine ENDS pods, or C) use ENDS as usual (control). The investigators adapted a protocol used in a prior study to assign participants to switch to ENDS pods with less nicotine or reduce number of ENDS pods in this trial. Specifically, the investigators will provide all participants with ENDS pods during the study period and instruct them to only use ENDS provided by the study. Participants in reduced nicotine condition will switch from usual nicotine (5% JUUL) to low nicotine ENDS (3% nicotine JUUL) pods. Participants in the reduced use condition will continue to use usual nicotine ENDS (5% nicotine JUUL) pods but reduce use to 60% of their baseline number of pods per week. Participants in the control condition will use usual nicotine ENDS (5% nicotine JUUL) pods as usual.

It is of considerable scientific and clinical importance to assess tobacco withdrawal accurately since withdrawal severity is highly determinant of smoking cessation success. In addition, smoking cessation pharmacotherapy produces its effects on smoking abstinence by suppressing such symptoms. However, in order to ensure that a measure of tobacco withdrawal is sensitive to severe withdrawal, it is essential to examine a period of unmedicated abstinence. The current study aims to validate, and possibly enhance, a revised Wisconsin Smoking Withdrawal Scale long and brief version for use in research and clinical settings. Two hundred adults who smoke cigarettes daily and report a desire to quit smoking will be enrolled. This is a treatment-delay, one-group clinical trial that is intended to enhance the assessment of tobacco withdrawal amongst participants who try to quit smoking with delayed use of cessation medication. Participants will not receive any pharmacotherapy during the first 1 week of their quit attempt and will initiate 8 weeks of combination nicotine replacement therapy (C-NRT; nicotine patch + nicotine mini-lozenge) starting 1 week past the target quit day (TQD). Participants will receive 4 counseling sessions as well (1 pre-quit, 3 post-quit). Participants will complete 4 weeks of ecological momentary assessment (EMA) smartphone surveys including a 2-week baseline (starting TQD-14) and 2-week post-TQD (1-week un-medicated, 1-week using C-NRT).