18 Clinical Trials for Various Conditions
This project addresses the need for evidence about the effect of flavoring manipulation on waterpipe smokers' satisfaction, dependence, harm perception, and toxicants exposure. Specifically, in this clinical study investigators will compare the effect on flavored and non-flavored waterpipe tobacco on smoking behavior, subjective experiences and toxicant exposure among waterpipe users. Findings from this study will help informing flavor-based product regulation by the FDA.
Hookah (water pipe) smoking is a new global epidemic. The World Health Organization wants to prohibit all claims that hookah is less harmful than cigarettes and wants hookah products to bear the same warning labels as cigarettes. But there is little scientific evidence to substantiate this proposal. Cigarettes, cigars, medicinal nicotine, and e-cigarettes all acutely impair brachial artery endothelial function (flow-mediated dilation, FMD). Also, cigarettes cause both acute and chronic impairment in coronary endothelial function, but the comparative effects of hookah are unknown. Hookah tobacco is heated with burning charcoal. So, the smoke contains "tar" and nicotine plus charcoal combustion products. These include carbon monoxide (CO) and proatherogenic oxidants (especially carbon-rich nanoparticles) that the study team expected to impair endothelial function.
This is a pilot study on the acute effects of nicotine-free hookah (herbal/steam stones) smoking on the sympathetic neural control of the human cardiovascular system. Hookah smoking is known to transiently increase blood pressure and heart rate while decreasing heart rate variability suggesting - but not proving - sympathetic mediation. The contribution of nicotine to these effects is unknown. Here the investigators will directly measure the acute effects of nicotine-free Hookah smoking on sympathetic nerve activity with microneurography (intraneural microelectrodes) and quantify associated regional changes in vasomotor tone.
This is a pilot study on acute effects of Hookah smoking on the sympathetic neural control of the human cardiovascular system. Hookah smoking is known to transiently increase blood pressure and heart rate while decreasing heart rate variability suggesting - but not proving - sympathetic mediation. Here the investigators will directly measure the acute effects of Hookah smoking on sympathetic nerve activity with microneurography (intraneural microelectrodes) and quantify associated regional changes in vasomotor tone.
This is a 2-arm randomized controlled trial to test the effects of hookah tobacco public education messages among young adults who are susceptible non-users of hookah tobacco and those who are current hookah tobacco users. The primary outcomes are hookah tobacco use behavior (initiation among baseline susceptible non-users, frequency of use and cessation among baseline current users) at 6-month follow-up. Secondary outcomes are curiosity to use hookah tobacco (susceptible non-users) and motivation to quit using hookah tobacco (current hookah users) measured at 6-month follow-up. These outcomes will also be measured at 2- and 4-month follow-up time points.
The objective of this study is to examine whether messages conveying the harms and addictiveness of waterpipe (i.e., hookah) tobacco delivered by mobile phone multimedia messaging (MMS) are effective for promoting hookah tobacco cessation among young adults ages 18 to 30 years.
In the United States, secondhand smoke is the third leading preventable cause of death. Flavored hookah (waterpipe) tobacco smoking, a highly social activity common in hookah bars, is a key source of SHS exposure. While smoke-free air laws have decreased exposure to secondhand smoke, the majority of laws do not include hookah smoking. Thus, as a social outlet for youth and young adults, hookah smoke exposure may harm non-smokers, including women of reproductive age or pregnant, hookah bar workers, children, and individuals with heart and lung disease. While more is known on the acute effects of active hookah smoking and the literature is emerging on active e-hookah vaping, little is known about the acute vascular effects of secondhand exposure to hookah smoke and aerosol. The study aims to examine the acute effects of secondhand exposure of hookah smoke and aerosol on endothelial and vascular function. Eligible volunteers will be invited to participate in a total of 3 study visits (2-3 hours each): e-hookah aerosol exposure, charcoal-heated hookah smoke exposure and smoke-free room air. Non-invasive blood pressure and blood flow measurements will be taken before and after the exposure sessions.
The purpose of this study is to assess the acute effects of Hookah (waterpipe) smoking on blood vessel function. Hookah smoking has been shown to immediately increase blood pressure and heart rate which could result in damage in the inner lining of the body's blood vessels.
The purpose of this study is to help us better understand what kinds of waterpipe tobacco advertisements appeal to young adults as well as to help evaluate and create health warnings that can be placed on waterpipe tobacco advertisements to inform young adults of the risks associated with smoking hookah tobacco.
The purpose of the current study is to investigate in a prospective randomized cross-over trial, the impact of alcohol versus a placebo drink on smoking behavior and topography (duration and frequency of puffing), abuse liability, and toxicity. It is hypothesized that drinking alcohol before smoking will be associated with longer puffs and shorter duration between puffs and greater abuse liability and toxicity.
The aim of this study is to compare exposure to tobacco smoke toxins in individuals who smoke both cigarettes and Hookah pipes. Sixteen subjects will be hospitalized on the research ward for two visits of 4 days each. At one visit they will smoke their usual cigarettes in approximately normal frequency, and at the other visit they will smoke Hookah at least twice per day. The order of the visits will be randomized. On the fourth day of each visit (when nicotine, carbon monoxide (CO), and some carcinogen levels will be in a steady state condition), circadian blood and urine and expired air samples will be collected.
The overall aim of the current study is to determine if flavorings contribute to the initiation and maintenance of waterpipe (WP) smoking and also influence how a WP is smoked, which has implications for both risk of dependence but also smokers' level of exposure to tobacco-related toxicants. A total of 94 current WP smokers (47 low dependent, 47 high dependent) will be recruited. Based on our team's previous studies we conservatively assume a 20% attrition rate; thus, we will need to recruit 94 participants to have 76 complete all four sessions. Consistent with other laboratory studies of waterpipe smoking, participants who meet the following eligibility criteria will be asked to take part in the study.
While the military has taken steps to reduce tobacco use over the past two decades, over a quarter of new military recruits report regular tobacco use prior to enlistment. This rate is higher than the national prevalence of 21.3% of US adults. Brief health prevention programs may be particularly effective for Airmen in Technical Training, given that all Airmen have been tobacco free for 11 ½ weeks and nearly 2/3rds are confident that they won't return to tobacco. We have developed and validated a Brief Tobacco Intervention (BTI) that is currently being implemented as part of Technical Training. We found that a motivational interviewing based, 40 minute BTI was efficacious in increasing perceived harm and decreasing intentions to use tobacco in a sample of 1055 Air Force trainees. Although we obtained significant positive changes in latent cognitive constructs for tobacco behavior that are highly predictive of future tobacco use in youth and young adults, the Little et al study did not obtain measures of actual tobacco resumption following the ban on tobacco in Air Force training. Given that 69.8% of all tobacco resumption/initiation occurs in Technical Training, a study that evaluates the short-term impact of our BTI on actual tobacco use is necessary prior to conducting the full scale R01 that would evaluate the long term efficacy of the BTI intervention. Thus, we propose the following Specific Aims: (1) To recruit approximately 2,000 Air Force trainees at the beginning of Technical Training at Joint Base San Antonio-Lackland Air Force in San Antonio, Texas during the 11 ½ week involuntary cessation ban; (2) To randomize participants to either (a) receive our cigarette smoking military tailored pamphlet (HL095758), The Airmen's Guide to Remaining Tobacco Free (Airmen's Guide; which has been disseminated and is now the standard of care in the Air Force) or (b) the Airmen's Guide + Brief Tobacco Intervention (BTI); (3) To determine the short-term (3 month, end of Technical Training) efficacy of the intervention on tobacco abstinence. Our primary outcome is tobacco abstinence at the end of Technical Training to determine an estimated effect size as well as establish the requisite preliminary work for a subsequent R01. Given that over 220,000 new recruits enter the military annually in one of the service branches, the public health implications of an effective brief tobacco intervention targeting the most commonly used tobacco for military personnel in Technical Training is considerable. If the BTI is proven efficacious it can be easily disseminated to other service branches that have similar tobacco bans during Technical Training.
The purpose of the study is to assess the effectiveness of health warnings on waterpipe smoking behavior in a real-world setting. The primary hypothesis is that hookah café customers who are in the intervention (warning) arm will smoke less than customers who are in the control (no warning) arm, determined by differences in the boost in expired carbon monoxide from café entry to after café exit.
Waterpipe smoking is a tobacco use method in which smoke passes through a partially-filled water jar. Burning charcoal heats the waterpipe tobacco which produces the smoke that the user inhales. Waterpipe smoking was associated with increased risk for coronary heart and pulmonary diseases. This Waterpipe Study will inform the FDA on regulating waterpipe tobacco products and reduce the harm of it use. This study will be conducted at homes of hookah smokers, in natural settings, aimed to determine the effects of waterpipe smoking practices on physiological injury markers and biomarkers of toxicity of waterpipe tobacco smoking. The investigators will employ a repeated measures design. The investigators will recruit a sample of 50 adult male and female exclusive waterpipe smokers and a control sample of 25 male and female non-smokers via intercept interviews from San Diego County, California communities. Waterpipe smokers will smoke one waterpipe tobacco head (10g) of Starbuzz during 3 separate sessions with a 7-day washout period before each session, as follows: Session 1, Smoking waterpipe tobacco using 1 quick-light charcoal and room temperature water in the waterpipe jar, Session 2, Smoking waterpipe tobacco using 1 quick-light charcoal and adding ice cubes to the water in the waterpipe jar, and Session 3, Smoking waterpipe tobacco without charcoal using a charcoal-free electrically heated waterpipe head to heat the tobacco, and room temperature water in the waterpipe jar. The following data will be collected: a) Tobacco Use History, b) 4-week Tobacco Exposure Diary, c) Waterpipe Use Session Form, d) Carbon monoxide (CO) exposure: Micro+ Smokerlyzer® CO monitor will be used for exhaled CO pre and 2 minutes post each smoking session, e) Pulmonary function testing and measuring blood pressure, heart rate and respiratory rate, and f) 6 first morning urine samples: pre and post the 3 sessions to measure urinary cotinine, a metabolite of nicotine, 4-(methylnitrosamino)-1- (3-pyridyl)-1-butanol (NNAL) and NNAL-glucuronides (total NNAL), metabolites of the lung carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), 1-hydroxypyrene (1-HOP), a metabolite of the genotoxic carcinogen pyrene, and S-phenylmercapturic acid (SPMA), a metabolite of the human hematotoxicant and leukemogen benzene. The investigators will explore exposure levels to furan, a liver toxicant and carcinogen, among waterpipe smokers via measuring its urinary metabolite, L-2-(acetylamino)-6-(2,5-dihydro-2-oxo-1H-pyrrol-1-yl)-1-hexanoic acid (Furan-BDA-NAL).
Electronic nicotine delivery systems (ENDS) are a rapidly growing global epidemic among adolescents and young adults. Unlike other ENDS such as e-cigarettes, e-hookahs are used through traditional water-pipes, allowing the vapor-containing nicotine, propylene glycol, glycerin, and flavorings-to pass through a water-filled basin, potentially altering the vapor, before it is inhaled through the user's mouth. Contributing to e-hookahs popularity is the belief that the flavored smoke is detoxified as it passes through the water-filled basin, rendering e-hookah a safer tobacco alternative. However, an e-hookahs deliver flavored nicotine by creating a vapor of fine particles and volatile organic compounds that could induce vascular toxicity. While e-hookah vaping acutely reduces endothelial function, the specific role of nicotine and the mechanisms by which it may impairs endothelial function remain understudied. The objective of this project is to investigate the specific role of nicotine in mediating the acute effects of e-hookah vaping on endothelial dysfunction.
The primary purpose of this study is to examine the health effects of mainstream and secondhand hookah (i.e. water pipe) smoke on pulmonary and cardiovascular functions as well as serum levels of inflammatory biomarkers. Investigators would like to demonstrate that inhalation of both mainstream and secondhand smoke generated by hookah produces adverse pulmonary and cardiovascular effects and alterations in serum levels of inflammatory biomarkers.
The purpose of the study is to evaluate the impact of marketing claims commonly found on waterpipe, also known as hookah, tobacco packages and in digital marketing on young adults' willingness to try hookah tobacco. Participants will complete two tasks, in random order. Participants will view six sample waterpipe tobacco packages, randomized at the package level to contain a prohibited or potentially-prohibited claim or not (Packaging Task). In the other task, they will view 10 digital marketing advertisements (i.e. Instagram posts or website pages) either with or without prohibited or potentially-prohibited claim, randomized at the advertisements level (Digital Marketing Task).