Waterpipe Smoking Clinical Trial
Official title:
Understanding Tobacco Flavor Effects on Waterpipe Smokers' Experiences and Exposures
Verified date | July 2020 |
Source | Florida International University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 144 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Generally healthy individuals (determined by physical examination). - Age of 18-30 years. - Is willing to provide informed consent. - Is willing to attend the lab as required by the study protocol. - WP smokers who smoke flavored WP tobacco. - Have abstained from WP for 12 hours prior to each session Exclusion Criteria: - Report smoking cigarettes regularly (> 5 cigarettes/month in the past year). - Report regular use of any other tobacco/nicotine product (e.g., e-cig, pipes, cigars) in the past year. - Women who are breast-feeding or test positive for pregnancy (by urinalysis at screening). - Individuals with self-reported history of chronic disease or psychiatric conditions. - Individuals with history of or active cardiovascular disease, low or high blood pressure, seizures, and regular use of prescription medications (other than vitamins or birth control). |
Country | Name | City | State |
---|---|---|---|
United States | Florida International University | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Florida International University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Heart rate | Change in heart rate, measured in beats per minute | During participants' 1st and 2nd visit. Heat rate will be measured from baseline continuously throughout each approximately 45-min sessionr | |
Other | Blood pressure | Change in blood pressure, measured in mm/hg | During participants' 1st and 2nd visit. Blood pressure will be measured from baseline continuously throughout each approximately 45-min session | |
Primary | Plasma nicotine | Change in plasma nicotine level | During participants' 1st and 2nd visit. Blood will be taken 2 times in each smoking session: before and after an approximately 45-min ad lib use period | |
Secondary | Puff topography | measurement of puffing behavior | During participants' 1st and 2nd visit. Puffing behavior is continuously measured during each smoking session (an approximately 45-min ad lib use period) | |
Secondary | Minnesota Nicotine Withdrawal Scale | This scale is used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 11 items scored 0 - 100. These items are presented as Visual Analog Scale with item (measure) centered above a horizontal line anchored on the left with not at all and on the right with extremely. | During participants' 1st and 2nd visit. Questionnaire will be administered 2 times in each smoking session: before and after an approximately 45-min ad lib use period. | |
Secondary | Tiffany-Drobes Questionnaire of Smoking Urges | This scale is used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 10 items that are scored 0 - 7. Rated on a 7-point Likert scale ranging from 0 (strongly disagree) to 6 (strongly agree). | During participants' 1st and 2nd visit. Questionnaire will be administered 2 times in each smoking session: before and after an approximately 45-min ad lib use period. | |
Secondary | Carbon monoxide levels | Change in carbon monoxide levels (in parts per mission) | During participants' 1st and 2nd visit. Carbon monoxide levels will be measured 2 times in each smoking session:before and after an approximately 45-min ad lib use period | |
Secondary | Harm perception | This scale assess waterpipe harm perception and measure perceptions of waterpipe relative risk compared to cigarettes. The scale will be scored on a 7-point scale ranging from 1 (not at all harmful), to 7 (extremely harmful). | During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period. | |
Secondary | Duke Sensory Questionnaire | This scale assess participants sensory experience of the inhaled product. The scale has nine items. All items will be scored on a 7-point Likert scale anchored at the extremes (1= not at all; 7=extremely). | During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period. | |
Secondary | The Cigarette/WP Evaluation Scale (WES) | This scale assesses participants' perception of the smoked waterpipe, The scale has 11 items. All items will be scored on a 7-point Likert scale anchored at the extremes (1= not at all; 7=extremely). | During participants' 1st and 2nd visit. Questionnaire will be administered after each of the 2 smoking sessions. Each session is approximately 45-min ad lib use period. |
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