Trial Outcomes & Findings for The Impact of Waterpipe Tobacco Flavors on Waterpipe Smoking Intentions, Perceptions, Patterns, and Toxicant Exposure (NCT NCT03232827)
NCT ID: NCT03232827
Last Updated: 2019-06-24
Results Overview
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).
COMPLETED
NA
91 participants
6 months
2019-06-24
Participant Flow
A total of 207 individuals were identified as eligible for study participation. Study personnel contacted the individuals by telephone to schedule their initial visit. 91 were consented and enrolled.
Subjects who were eligible \& presented to initial visit 12 hour tobacco abstinent were randomized. Subjects were randomized to 1 of 36 session sequences \& completed up to four smoking sessions. 2 subjects were not nicotine abstinent at their initial visit, were rescheduled \& lost to follow-up.
Participant milestones
| Measure |
All Interventions
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 preferred flavored-very low sweetened WP tobacco and 4) smoking unflavored-very low sweetened WP tobacco. Participants will complete all four 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 first complete a 10-minute puffing session separated by 30-second intervals with the prepared hookah and then smoke 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.
|
|---|---|
|
Flavored-sweetened (FS)
STARTED
|
80
|
|
Flavored-sweetened (FS)
COMPLETED
|
80
|
|
Flavored-sweetened (FS)
NOT COMPLETED
|
0
|
|
Unflavored-sweetened (US)
STARTED
|
86
|
|
Unflavored-sweetened (US)
COMPLETED
|
86
|
|
Unflavored-sweetened (US)
NOT COMPLETED
|
0
|
|
Unflavored-very Low Sweetened (UU)
STARTED
|
66
|
|
Unflavored-very Low Sweetened (UU)
COMPLETED
|
66
|
|
Unflavored-very Low Sweetened (UU)
NOT COMPLETED
|
0
|
|
Flavored-very Low Sweetened
STARTED
|
66
|
|
Flavored-very Low Sweetened
COMPLETED
|
66
|
|
Flavored-very Low Sweetened
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Impact of Waterpipe Tobacco Flavors on Waterpipe Smoking Intentions, Perceptions, Patterns, and Toxicant Exposure
Baseline characteristics by cohort
| Measure |
All Study Participants
n=89 Participants
Participants completed up to 4 smoking sessions and were randomized to 1 of 36 session sequences: 1) FS - UU - US, 2) UU - FS - US, 3) US - UU - FS, 4) FS - US - UU, 5) US - FS - UU, 6) UU - US - FS, 7) UU - FU - US - FS, 8) UU - FU - FS - US, 9) UU - US - FS - FU, 10) UU - US - FU - FS, 11) UU - FS - US - FU, 12) UU - FS - FU - US, 13) FU - UU - US - FS, 14) FU - UU - FS - US, 15) FU - US - FS - UU, 16) FU - US - UU - FS, 17) FU - FS - UU - US, 18) FU - FS - US - UU, 19) US - UU - FU - FS, 20) US - UU - FS - FU, 21) US - FU - UU - FS, 22) US - FU - FS - UU, 23) US - FS - UU - FU, 24) US - FS - FU - UU, 25) FS - UU - FU - US, 26) FS - UU - US - FU, 27) FS - FU - UU - US, 28) FS - FU - US - UU, 29) FS - US - FU - UU, 30) FS - US - UU - FU, 31) UU - FU - FS - US, 32) FS - UU - FU - US, 33) FU - FS - US - UU, 34) US - UU - FS - FU, 35) FU - US - UU - FS, 36) UU - US - FU - FS. A fourth arm (FU) was added to the study one month after the study started.
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|---|---|
|
Age, Continuous
|
23.98 years
STANDARD_DEVIATION 5.58 • n=99 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
89 participants
n=99 Participants
|
|
Waterpipe smoking days per month
|
6.5 Days
STANDARD_DEVIATION 8.3 • n=99 Participants
|
|
Waterpipe dependence
Low Dependence
|
50 Participants
n=99 Participants
|
|
Waterpipe dependence
High Dependence
|
39 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 1 participant was not included in analysis due to self-withdraw. Participants who completed one or more of the individual intervention visits were included.
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).
Outcome measures
| Measure |
Flavored-sweetened
n=80 Participants
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.
Flavored-Sweetened Waterpipe Tobacco: Pre-weighed flavored-sweetened waterpipe tobacco will be prepared.
|
Unflavored-sweetened
n=86 Participants
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).
Unflavored-sweetened waterpipe tobacco: Pre-weighed unflavored-sweetened waterpipe tobacco will be prepared.
|
Unflavored Very Low Sweetened
n=66 Participants
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).
Unflavored-very low sweetened waterpipe tobacco: Pre-weighed unflavored-very low sweetened waterpipe tobacco will be prepared.
|
Flavored-very Low Sweetened Waterpipe
n=66 Participants
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).
Flavored-very low sweetened waterpipe: Pre-weighed flavored-very low sweetened waterpipe tobacco will be prepared.
|
|---|---|---|---|---|
|
Level of Smoke Inhalation Measured by Topography Device
|
50.96 Liters
Standard Error 5.46
|
77.79 Liters
Standard Error 5.89
|
63.17 Liters
Standard Error 5.87
|
51.60 Liters
Standard Error 4.63
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 1 participant was not included in analysis due to self-withdraw. Participants who completed one or more of the individual intervention visits were included.
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
Outcome measures
| Measure |
Flavored-sweetened
n=80 Participants
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.
Flavored-Sweetened Waterpipe Tobacco: Pre-weighed flavored-sweetened waterpipe tobacco will be prepared.
|
Unflavored-sweetened
n=86 Participants
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).
Unflavored-sweetened waterpipe tobacco: Pre-weighed unflavored-sweetened waterpipe tobacco will be prepared.
|
Unflavored Very Low Sweetened
n=66 Participants
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).
Unflavored-very low sweetened waterpipe tobacco: Pre-weighed unflavored-very low sweetened waterpipe tobacco will be prepared.
|
Flavored-very Low Sweetened Waterpipe
n=66 Participants
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).
Flavored-very low sweetened waterpipe: Pre-weighed flavored-very low sweetened waterpipe tobacco will be prepared.
|
|---|---|---|---|---|
|
Levels of Smoke Inhalation Between High vs. Low Dependent WP
Low Dependence
|
42.18 Liters
Standard Error 5.02
|
55.85 Liters
Standard Error 5.84
|
46.18 Liters
Standard Error 6.03
|
39.43 Liters
Standard Error 4.54
|
|
Levels of Smoke Inhalation Between High vs. Low Dependent WP
High Dependence
|
32.15 Liters
Standard Error 6.26
|
57.31 Liters
Standard Error 6.95
|
51.07 Liters
Standard Error 7.26
|
33.96 Liters
Standard Error 5.01
|
Adverse Events
Flavored Sweetened
Unflavored Sweetened
Unflavored Very Low Sweetened
Flavored-very Low Sweetened Waterpipe
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Theodore Wagener
UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place