The Impact of Waterpipe Tobacco Flavors on Waterpipe Smoking Intentions, Perceptions, Patterns, and Toxicant Exposure
1 other identifier
interventional
91
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 22, 2017
CompletedFirst Posted
Study publicly available on registry
July 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2018
CompletedResults Posted
Study results publicly available
June 24, 2019
CompletedJune 24, 2019
June 1, 2019
9 months
June 22, 2017
April 1, 2019
June 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Level of Smoke Inhalation Measured by Topography Device
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).
6 months
Secondary Outcomes (1)
Levels of Smoke Inhalation Between High vs. Low Dependent WP
6 months
Study Arms (4)
Flavored-sweetened
ACTIVE COMPARATORFlavored-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.
Unflavored-sweetened
ACTIVE COMPARATORUnflavored-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).
Unflavored very low sweetened
ACTIVE COMPARATORUnflavored-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).
Flavored-very low sweetened waterpipe
ACTIVE COMPARATORFlavored-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).
Interventions
Pre-weighed flavored-sweetened waterpipe tobacco will be prepared.
Pre-weighed unflavored-sweetened waterpipe tobacco will be prepared.
Pre-weighed unflavored-very low sweetened waterpipe tobacco will be prepared.
Pre-weighed flavored-very low sweetened waterpipe tobacco will be prepared.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oklahomalead
- Virginia Commonwealth Universitycollaborator
- American University of Beirut Medical Centercollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
University of Oklahoma Health Sciences Center Tobacco Research Center
Oklahoma City, Oklahoma, 73104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Theodore Wagener
- Organization
- UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR
Study Officials
- PRINCIPAL INVESTIGATOR
Theodore Wagener, PhD
University of Oklahoma
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2017
First Posted
July 28, 2017
Study Start
June 1, 2017
Primary Completion
March 12, 2018
Study Completion
March 12, 2018
Last Updated
June 24, 2019
Results First Posted
June 24, 2019
Record last verified: 2019-06