- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03232827
The Impact of Waterpipe Tobacco Flavors on Waterpipe Smoking Intentions, Perceptions, Patterns, and Toxicant Exposure
Study Overview
Status
Conditions
Detailed Description
After completing the initial screening by phone, participants will be informed of the study procedures and invited to the lab to complete three WP smoking sessions. Participants will perform exhaled carbon monoxide testing (eCO< 10ppm) and confirm that they have not used any nicotine/tobacco/marijuana products over the last 12 hours. Pregnancy exclusion will also be confirmed with a urine test, and pregnancy tests will be completed at each visit throughout the study. Participants will be randomized and complete study procedures in self-selected dyads. The sessions will be counterbalanced and include: 1) smoking preferred flavored-sweetened WP tobacco, 2) smoking unflavored-sweetened WP tobacco, and 3) smoking unflavored-very low sweetened WP tobacco. Participants will complete all three study visits in the laboratory. Pre-session abstinence from tobacco for at least 12 hours will be mandatory for all participants. Abstinence will be confirmed via participant self-report and an exhaled carbon monoxide monitor (< 20 ppm) for tobacco use. Participant dyads will smoke hookah ad libitum for up to 1 hour. This procedure will be completed for all visits. Participants will also complete a minimum 48-hour washout period between sessions.
Participants will not be allowed to eat, drink or use their phone during the session. Initially, one piece of charcoal will be lit and placed on top of the foil. Our preliminary studies, as well as other WP laboratory trials, indicate that one piece of charcoal will not be sufficient for one WP session; thus, participants will be provided additional pre-weighed pieces to use as they wish. Use of additional charcoal will be recorded. Participants will smoke ad libitum and a WP puff topography device will discretely record smoking behavior throughout the session, including puff duration, number of puffs, puff volume, puff flow rate, and time between puffs. Blood samples (15mL per sample) and eCO will be collected immediately pre- and post-waterpipe session. Self-report measures will be administered.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center Tobacco Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- current water pipe smoker for at least the past 6 months
- smoke water pipe at least 3 times in the last 6 months
- Lebanese Waterpipe Dependence Scale-11 (LWDS-11) score of ≤9 (Low Dependence) or ≥10 (High Dependence)
- between 18-50 years old
- willing to provide informed consent
- abstain from all tobacco, nicotine, and marijuana use for at least 12 hours prior to each of the three sessions
Exclusion Criteria:
- self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
- currently pregnant, planning to become pregnant, or breastfeeding
- history of cardiac event or distress within the last 3 months
- any use of other illicit drugs during the last 30 days.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Flavored-sweetened
Flavored-sweetened (FS) WP tobacco will be associated with longer and more frequent puffing resulting in the greatest overall levels of smoke inhalation (mL of smoke inhaled), highest abuse potential, and greatest levels of exposure to nicotine and carbon monoxide (CO).
, followed by unflavored-sweetened WP, and lastly unflavored-very low sweetened WP. (H1d) A majority of WP smokers will report having initiated WP smoking with flavored-sweetened tobacco and report flavoring as an important reason for trying WP.
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Pre-weighed flavored-sweetened waterpipe tobacco will be prepared.
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Active Comparator: Unflavored-sweetened
Unflavored-sweetened (US) WP will be associated with the second longest and slightly less frequent puffing than FS resulting in the second greatest overall levels of smoke inhalation (mL of smoke inhaled), abuse potential, and levels of exposure to nicotine and carbon monoxide (CO).
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Pre-weighed unflavored-sweetened waterpipe tobacco will be prepared.
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Active Comparator: Unflavored very low sweetened
Unflavored-very low sweetened (UU) WP will be associated with the shortest and the least frequent puffing resulting in the least overall levels of smoke inhalation (mL of smoke inhaled), abuse potential, and levels of exposure to nicotine and carbon monoxide (CO).
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Pre-weighed unflavored-very low sweetened waterpipe tobacco will be prepared.
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Active Comparator: Flavored-very low sweetened waterpipe
Flavored-very low sweetened WP will be associated with the third longest and slightly less frequent puffing than US resulting in the third greatest overall levels of smoke inhalation (mL of smoke inhaled), abuse potential, and levels of exposure to nicotine and carbon monoxide (CO).
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Pre-weighed flavored-very low sweetened waterpipe tobacco will be prepared.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of Smoke Inhalation Measured by Topography Device
Time Frame: 6 months
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Participants will complete one ad-lib puffing session at each visit.
Levels of smoke inhalation will be measured throughout each ad-lib puffing session.
Flavored-sweetened WP tobacco will be associated with longer and more frequent puffing resulting in the greatest overall levels of smoke inhalation (mL of smoke inhaled).
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Levels of Smoke Inhalation Between High vs. Low Dependent WP
Time Frame: 6 months
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Waterpipe dependence for participants will be determined at baseline.
Participants will complete one ad-lib puffing session at each visit.
Levels of smoke inhalation will be measured throughout each ad-lib puffing session.
Flavored-sweetened WP tobacco will be associated with longer and more frequent puffing resulting in the greatest overall levels of smoke inhalation (mL of smoke inhaled).
Compared to high dependence users smoking unflavored WP tobacco, low dependence users will show greater declines in (H2a) puff frequency and duration resulting in lower levels of smoke inhalation
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Theodore Wagener, PhD, University of Oklahoma
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1R03DA041928-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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