Trial Outcomes & Findings for Hookah Additive Research to Inform Product Standards (NCT NCT05453773)
NCT ID: NCT05453773
Last Updated: 2024-12-31
Results Overview
Change from baseline exhaled breath carbon monoxide (boost). CO was collected before and immediately after each smoking session with a handheld electrochemical cell.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
Approximately 30 to 90 minutes
Results posted on
2024-12-31
Participant Flow
Participant milestones
| Measure |
Overall Population
Full population of participants participating in the randomized crossover trial. Over a series of four laboratory sessions each participant received all four treatments in a randomized order, one treatment per session.
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
High Humectant, High Sweetness
|
47
|
|
Overall Study
High Humectant, Medium Sweetness
|
46
|
|
Overall Study
Medium Humectant, High Sweetness
|
46
|
|
Overall Study
Medium Humectant, Medium Sweetness
|
48
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Overall Population
Full population of participants participating in the randomized crossover trial. Over a series of four laboratory sessions each participant received all four treatments in a randomized order, one treatment per session.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Difficult Blood Draw
|
3
|
Baseline Characteristics
Hookah Additive Research to Inform Product Standards
Baseline characteristics by cohort
| Measure |
Overall Population
n=51 Participants
Population of randomized participants who fully completed at least one study visit
|
|---|---|
|
Age, Continuous
|
27.55 years
STANDARD_DEVIATION 4.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Age when first tried Waterpipe
|
18.69 years
STANDARD_DEVIATION 4.47 • n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 30 to 90 minutesChange from baseline exhaled breath carbon monoxide (boost). CO was collected before and immediately after each smoking session with a handheld electrochemical cell.
Outcome measures
| Measure |
High Humectant, High Sweetness
n=47 Participants
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
n=46 Participants
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
n=46 Participants
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
n=48 Participants
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Change in Exhaled Breath Carbon Monoxide (CO)
|
80.1 ppm
Standard Deviation 76.9
|
40.8 ppm
Standard Deviation 28.5
|
62.5 ppm
Standard Deviation 49.5
|
45.5 ppm
Standard Deviation 31.1
|
PRIMARY outcome
Timeframe: Approximately 30 to 90 minutesPopulation: Participants who attended their study visit and were able to provide a plasma sample
Change from baseline plasma nicotine (boost): Whole blood was collected before and immediately after each smoking session, separated, and plasma layer transferred and stored at -80 °C until analysis for nicotine according to validated methods using LC-MS/MS.
Outcome measures
| Measure |
High Humectant, High Sweetness
n=45 Participants
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
n=43 Participants
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
n=44 Participants
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
n=44 Participants
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Change in Plasma Nicotine
|
5.1 ng/mL
Standard Deviation 3.7
|
8.3 ng/mL
Standard Deviation 8.4
|
6.9 ng/mL
Standard Deviation 6.2
|
8.8 ng/mL
Standard Deviation 8.7
|
PRIMARY outcome
Timeframe: Approximately 30 to 90 minutesPopulation: Spirometry was not collected at the end of the session for 1 participant during their medium humectant, high sweetness study visit.
Spirometer measurements will be collected - change in forced vital capacity (FVC) (post-pre).
Outcome measures
| Measure |
High Humectant, High Sweetness
n=47 Participants
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
n=46 Participants
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
n=45 Participants
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
n=48 Participants
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Change in Forced Vital Capacity (FVC)
|
-0.11 Liters
Standard Deviation 0.44
|
-0.03 Liters
Standard Deviation 0.26
|
0.02 Liters
Standard Deviation 0.16
|
0.05 Liters
Standard Deviation 0.33
|
PRIMARY outcome
Timeframe: Approximately 30 to 90 minutesPopulation: Spirometry was not collected at the end of the session for 1 participant during their medium humectant, high sweetness study visit.
Spirometer measurements will be collected - change in forced expiratory volume in 1 second (FEV1) (post-pre)
Outcome measures
| Measure |
High Humectant, High Sweetness
n=47 Participants
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
n=46 Participants
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
n=45 Participants
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
n=48 Participants
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Change in Forced Expiratory Volume in 1 Second (FEV1)
|
-0.05 Liters
Standard Deviation 0.37
|
-0.06 Liters
Standard Deviation 0.22
|
-0.02 Liters
Standard Deviation 0.29
|
-0.002 Liters
Standard Deviation 0.33
|
PRIMARY outcome
Timeframe: Approximately 30 to 90 minutesPopulation: Spirometry was not collected at the end of the session for 1 participant during their medium humectant, high sweetness study visit.
Spirometer measurements will be collected - change in FEV1/FVC, the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs (post-pre).
Outcome measures
| Measure |
High Humectant, High Sweetness
n=47 Participants
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
n=46 Participants
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
n=45 Participants
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
n=48 Participants
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Change in FEV1/FVC; The Ratio of the Forced Expiratory Volume in the First One Second to the Forced Vital Capacity of the Lungs.
|
0.01 ratio
Standard Deviation 0.05
|
-0.01 ratio
Standard Deviation 0.04
|
-0.01 ratio
Standard Deviation 0.06
|
-0.01 ratio
Standard Deviation 0.08
|
PRIMARY outcome
Timeframe: Approximately 30 to 90 minutesPopulation: Spirometry was not collected at the end of the session for 1 participant during their medium humectant, high sweetness study visit.
Spirometer measurements will be collected - change in peak expiratory flow (PEF) (post-pre).
Outcome measures
| Measure |
High Humectant, High Sweetness
n=47 Participants
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
n=46 Participants
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
n=45 Participants
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
n=48 Participants
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Change in Peak Expiratory Flow (PEF)
|
-0.33 Liters / second
Standard Deviation 1.12
|
-0.38 Liters / second
Standard Deviation 1.05
|
-0.41 Liters / second
Standard Deviation 1.03
|
-0.33 Liters / second
Standard Deviation 1.27
|
PRIMARY outcome
Timeframe: Approximately 30 to 90 minutesPopulation: Spirometry was not collected at the end of the session for 1 participant during their medium humectant, high sweetness study visit.
Spirometer measurements will be collected - change in forced expiratory flow at 25-75% of FVC (post-pre).
Outcome measures
| Measure |
High Humectant, High Sweetness
n=47 Participants
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
n=46 Participants
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
n=45 Participants
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
n=48 Participants
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Change in Forced Expiratory Flow at 25-75% of FVC
|
0.05 L/s
Standard Deviation 0.14
|
-0.03 L/s
Standard Deviation 0.14
|
0.0001 L/s
Standard Deviation 0.16
|
-0.01 L/s
Standard Deviation 0.23
|
PRIMARY outcome
Timeframe: BaselineEver use of tobacco products, assessed at the first study visit
Outcome measures
| Measure |
High Humectant, High Sweetness
n=51 Participants
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Tobacco Use History
Cigarettes
|
30 Participants
|
—
|
—
|
—
|
|
Tobacco Use History
Cigars
|
36 Participants
|
—
|
—
|
—
|
|
Tobacco Use History
Cigarillos or Little Cigars
|
30 Participants
|
—
|
—
|
—
|
|
Tobacco Use History
Smokeless Tobacco
|
13 Participants
|
—
|
—
|
—
|
|
Tobacco Use History
Juul or Other Brands of Pod-like Electronic Cigarettes
|
31 Participants
|
—
|
—
|
—
|
|
Tobacco Use History
Non-Juul Electronic Cigarettes
|
29 Participants
|
—
|
—
|
—
|
|
Tobacco Use History
Pipe Tobacco
|
19 Participants
|
—
|
—
|
—
|
|
Tobacco Use History
Bidis or Kreteks
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselineHooked on Nicotine Checklist (HONC) comprised of 10 "Yes" or "No" questions, assessed on the first study visit. Scores range from 0 to 10 with higher scores indicating greater nicotine dependence.
Outcome measures
| Measure |
High Humectant, High Sweetness
n=51 Participants
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Nicotine Dependence (HONC)
|
2.16 score on a scale
Standard Deviation 2.61
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselineLebanese Waterpipe Dependence Scale (LWDS) comprised of twelve questions and assessed on the first study visit. LWDS values range from 0 to 36 where higher sores indicate greater nicotine dependence.
Outcome measures
| Measure |
High Humectant, High Sweetness
n=51 Participants
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Nicotine Dependence (LWDS)
|
7.88 score on a scale
Standard Deviation 4.28
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Post Smoking SessionAssessed using harm/health risk perceptions questionnaire. General harm is rated after the smoking session on a scale from 0 (no harm) to 10 (extreme harm) with higher scores indicating a greater perceived harm/health risk.
Outcome measures
| Measure |
High Humectant, High Sweetness
n=47 Participants
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
n=46 Participants
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
n=46 Participants
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
n=48 Participants
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
General Harm and Health Risk Perceptions
|
5.89 score on a scale
Standard Deviation 2.03
|
6.35 score on a scale
Standard Deviation 2.16
|
6.15 score on a scale
Standard Deviation 2.05
|
6.13 score on a scale
Standard Deviation 2.19
|
PRIMARY outcome
Timeframe: Post Smoking SessionDirect Effects of Tobacco scale; the scale for each effect ranges from 0 (not at all) to 100 (extremely) with higher ratings indicating a greater effect of the tobacco.
Outcome measures
| Measure |
High Humectant, High Sweetness
n=47 Participants
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
n=46 Participants
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
n=46 Participants
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
n=48 Participants
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Subjective Effects of Smoking Tobacco
Taste Good
|
29.17 score on a scale
Standard Deviation 28.58
|
19.00 score on a scale
Standard Deviation 22.53
|
22.15 score on a scale
Standard Deviation 23.00
|
21.85 score on a scale
Standard Deviation 25.68
|
|
Subjective Effects of Smoking Tobacco
Taste Bad
|
45.60 score on a scale
Standard Deviation 33.48
|
56.17 score on a scale
Standard Deviation 33.68
|
50.57 score on a scale
Standard Deviation 33.97
|
52.08 score on a scale
Standard Deviation 35.71
|
|
Subjective Effects of Smoking Tobacco
Satisfying
|
34.17 score on a scale
Standard Deviation 29.04
|
27.24 score on a scale
Standard Deviation 26.87
|
29.15 score on a scale
Standard Deviation 26.00
|
26.17 score on a scale
Standard Deviation 25.88
|
|
Subjective Effects of Smoking Tobacco
Pleasant
|
34.60 score on a scale
Standard Deviation 29.28
|
27.07 score on a scale
Standard Deviation 27.94
|
26.80 score on a scale
Standard Deviation 25.49
|
25.75 score on a scale
Standard Deviation 24.24
|
|
Subjective Effects of Smoking Tobacco
Make you Dizzy
|
10.94 score on a scale
Standard Deviation 15.58
|
14.46 score on a scale
Standard Deviation 24.43
|
16.76 score on a scale
Standard Deviation 21.25
|
18.21 score on a scale
Standard Deviation 22.36
|
|
Subjective Effects of Smoking Tobacco
Calm you Down
|
30.21 score on a scale
Standard Deviation 30.69
|
22.65 score on a scale
Standard Deviation 27.93
|
26.63 score on a scale
Standard Deviation 28.97
|
26.56 score on a scale
Standard Deviation 30.23
|
|
Subjective Effects of Smoking Tobacco
Feel Confused
|
3.62 score on a scale
Standard Deviation 9.89
|
3.30 score on a scale
Standard Deviation 11.83
|
3.15 score on a scale
Standard Deviation 8.31
|
3.19 score on a scale
Standard Deviation 11.23
|
|
Subjective Effects of Smoking Tobacco
Help you Concentrate
|
21.43 score on a scale
Standard Deviation 29.82
|
13.63 score on a scale
Standard Deviation 23.26
|
13.54 score on a scale
Standard Deviation 25.45
|
13.56 score on a scale
Standard Deviation 23.70
|
|
Subjective Effects of Smoking Tobacco
Feel More Awake
|
25.66 score on a scale
Standard Deviation 31.31
|
12.67 score on a scale
Standard Deviation 20.82
|
18.70 score on a scale
Standard Deviation 27.63
|
17.31 score on a scale
Standard Deviation 25.29
|
|
Subjective Effects of Smoking Tobacco
Reduce Hunger
|
17.89 score on a scale
Standard Deviation 27.80
|
13.67 score on a scale
Standard Deviation 23.71
|
12.11 score on a scale
Standard Deviation 21.99
|
14.98 score on a scale
Standard Deviation 25.19
|
|
Subjective Effects of Smoking Tobacco
Make you Sick
|
4.55 score on a scale
Standard Deviation 9.59
|
7.13 score on a scale
Standard Deviation 16.72
|
9.33 score on a scale
Standard Deviation 16.43
|
8.60 score on a scale
Standard Deviation 16.86
|
|
Subjective Effects of Smoking Tobacco
Make you Sleepy
|
12.43 score on a scale
Standard Deviation 21.03
|
12.76 score on a scale
Standard Deviation 21.36
|
12.48 score on a scale
Standard Deviation 21.13
|
6.65 score on a scale
Standard Deviation 16.06
|
|
Subjective Effects of Smoking Tobacco
Like to smoke another hookah right now
|
25.64 score on a scale
Standard Deviation 30.30
|
13.35 score on a scale
Standard Deviation 21.61
|
16.09 score on a scale
Standard Deviation 25.34
|
17.00 score on a scale
Standard Deviation 24.23
|
PRIMARY outcome
Timeframe: Approximately 30 to 90 minutesPopulation: Data is missing for 1 participant from the High Humectant, High Sweetness and Medium Humectant, Medium Sweetness arms as they declined to respond to the pre-smoking survey items.
Change in Direct Effects of Nicotine scale from baseline (post - pre). The scale for each effect ranges from 0 (not at all) to 100 (extremely) with higher ratings indicating a greater effect of the tobacco.
Outcome measures
| Measure |
High Humectant, High Sweetness
n=46 Participants
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
n=46 Participants
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
n=46 Participants
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
n=47 Participants
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Change in Subjective Effects of Smoking Tobacco - Direct Effects of Nicotine
Weak
|
-1.20 score on a scale
Standard Deviation 7.17
|
0.39 score on a scale
Standard Deviation 10.36
|
1.50 score on a scale
Standard Deviation 10.94
|
0.81 score on a scale
Standard Deviation 6.54
|
|
Change in Subjective Effects of Smoking Tobacco - Direct Effects of Nicotine
Nauseous
|
0.33 score on a scale
Standard Deviation 9.45
|
-0.07 score on a scale
Standard Deviation 11.98
|
-0.02 score on a scale
Standard Deviation 13.18
|
2.94 score on a scale
Standard Deviation 13.02
|
|
Change in Subjective Effects of Smoking Tobacco - Direct Effects of Nicotine
Dizzy
|
0.96 score on a scale
Standard Deviation 9.72
|
0.89 score on a scale
Standard Deviation 13.17
|
2.57 score on a scale
Standard Deviation 10.24
|
2.57 score on a scale
Standard Deviation 11.98
|
|
Change in Subjective Effects of Smoking Tobacco - Direct Effects of Nicotine
Lightheaded
|
6.80 score on a scale
Standard Deviation 13.95
|
0.74 score on a scale
Standard Deviation 13.92
|
4.91 score on a scale
Standard Deviation 17.73
|
4.19 score on a scale
Standard Deviation 14.75
|
|
Change in Subjective Effects of Smoking Tobacco - Direct Effects of Nicotine
Nervous
|
-2.13 score on a scale
Standard Deviation 5.96
|
-2.09 score on a scale
Standard Deviation 9.13
|
-0.67 score on a scale
Standard Deviation 3.39
|
1.23 score on a scale
Standard Deviation 6.85
|
|
Change in Subjective Effects of Smoking Tobacco - Direct Effects of Nicotine
Sweaty
|
0.28 score on a scale
Standard Deviation 6.90
|
-1.20 score on a scale
Standard Deviation 8.62
|
1.09 score on a scale
Standard Deviation 7.31
|
1.51 score on a scale
Standard Deviation 11.37
|
|
Change in Subjective Effects of Smoking Tobacco - Direct Effects of Nicotine
Headache
|
-0.93 score on a scale
Standard Deviation 14.04
|
-1.48 score on a scale
Standard Deviation 18.86
|
1.96 score on a scale
Standard Deviation 13.96
|
1.21 score on a scale
Standard Deviation 11.66
|
|
Change in Subjective Effects of Smoking Tobacco - Direct Effects of Nicotine
Excessive Salivation
|
3.15 score on a scale
Standard Deviation 11.08
|
-0.67 score on a scale
Standard Deviation 13.21
|
1.43 score on a scale
Standard Deviation 9.95
|
2.81 score on a scale
Standard Deviation 12.65
|
|
Change in Subjective Effects of Smoking Tobacco - Direct Effects of Nicotine
Heart Pounding
|
0.30 score on a scale
Standard Deviation 6.15
|
0.02 score on a scale
Standard Deviation 9.07
|
0.20 score on a scale
Standard Deviation 5.95
|
2.13 score on a scale
Standard Deviation 8.83
|
|
Change in Subjective Effects of Smoking Tobacco - Direct Effects of Nicotine
Confused
|
-0.30 score on a scale
Standard Deviation 2.14
|
-0.76 score on a scale
Standard Deviation 8.39
|
0.28 score on a scale
Standard Deviation 3.89
|
0.23 score on a scale
Standard Deviation 3.30
|
PRIMARY outcome
Timeframe: Approximately 30 to 90 minutesPopulation: 1 participant in the high humectant, medium sweetness arm and 1 participant in the medium humectant, medium sweetness arm declined to provide responses post-smoking.
Change from baseline Questionnaire for Urges to Smoke (post - pre). This is a 10-item measure where participants rate smoking-related items on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). Items are collapsed into two previously identified factors (Factor 1: strong desire and intention to smoke; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 30 with higher scores indicating greater urge to smoke.
Outcome measures
| Measure |
High Humectant, High Sweetness
n=47 Participants
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
n=45 Participants
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
n=46 Participants
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
n=47 Participants
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Change in Subjective Effects of Smoking Tobacco (QSU)
Desire
|
-7.28 score on a scale
Standard Deviation 6.30
|
-9.16 score on a scale
Standard Deviation 6.63
|
-7.22 score on a scale
Standard Deviation 6.14
|
-7.66 score on a scale
Standard Deviation 6.49
|
|
Change in Subjective Effects of Smoking Tobacco (QSU)
Relief
|
-2.13 score on a scale
Standard Deviation 3.84
|
-2.38 score on a scale
Standard Deviation 4.14
|
-2.46 score on a scale
Standard Deviation 4.55
|
-2.23 score on a scale
Standard Deviation 3.96
|
PRIMARY outcome
Timeframe: Approximately 30 to 90 minutesChange from baseline using Waterpipe-modified Minnesota Withdrawal Scale (post - pre). The scale ranges from 0 (not at all) to 100 (extremely) with higher total numbers meaning greater withdrawal symptoms.
Outcome measures
| Measure |
High Humectant, High Sweetness
n=47 Participants
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
n=46 Participants
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
n=46 Participants
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
n=48 Participants
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Change in Nicotine Withdrawal Assessment (MNWS)
Impatient
|
-5.19 score on a scale
Standard Deviation 16.35
|
-3.13 score on a scale
Standard Deviation 11.19
|
-2.17 score on a scale
Standard Deviation 19.07
|
-1.92 score on a scale
Standard Deviation 18.80
|
|
Change in Nicotine Withdrawal Assessment (MNWS)
Urges to Smoke a Waterpipe
|
-15.64 score on a scale
Standard Deviation 26.68
|
-25.15 score on a scale
Standard Deviation 27.80
|
-17.02 score on a scale
Standard Deviation 27.51
|
-20.17 score on a scale
Standard Deviation 26.92
|
|
Change in Nicotine Withdrawal Assessment (MNWS)
Irritability/Frustration/Anger
|
-6.94 score on a scale
Standard Deviation 15.46
|
-2.26 score on a scale
Standard Deviation 14.56
|
-2.17 score on a scale
Standard Deviation 10.28
|
-5.25 score on a scale
Standard Deviation 17.87
|
|
Change in Nicotine Withdrawal Assessment (MNWS)
Anxious
|
-5.51 score on a scale
Standard Deviation 16.11
|
-2.65 score on a scale
Standard Deviation 10.47
|
-2.85 score on a scale
Standard Deviation 12.81
|
-2.88 score on a scale
Standard Deviation 14.83
|
|
Change in Nicotine Withdrawal Assessment (MNWS)
Difficulty Concentrating
|
-5.72 score on a scale
Standard Deviation 19.01
|
-2.30 score on a scale
Standard Deviation 10.61
|
-4.46 score on a scale
Standard Deviation 16.99
|
-5.27 score on a scale
Standard Deviation 20.12
|
|
Change in Nicotine Withdrawal Assessment (MNWS)
Restlessness
|
-4.68 score on a scale
Standard Deviation 18.51
|
-5.63 score on a scale
Standard Deviation 17.58
|
-0.13 score on a scale
Standard Deviation 13.45
|
-2.88 score on a scale
Standard Deviation 13.89
|
|
Change in Nicotine Withdrawal Assessment (MNWS)
Hunger
|
6.04 score on a scale
Standard Deviation 26.84
|
6.87 score on a scale
Standard Deviation 24.78
|
5.48 score on a scale
Standard Deviation 20.38
|
5.31 score on a scale
Standard Deviation 21.76
|
|
Change in Nicotine Withdrawal Assessment (MNWS)
Craving a Waterpipe/Nicotine
|
-15.55 score on a scale
Standard Deviation 26.68
|
-19.70 score on a scale
Standard Deviation 28.96
|
-14.17 score on a scale
Standard Deviation 30.12
|
-13.13 score on a scale
Standard Deviation 29.38
|
|
Change in Nicotine Withdrawal Assessment (MNWS)
Drowsiness
|
-4.38 score on a scale
Standard Deviation 16.61
|
-5.83 score on a scale
Standard Deviation 11.58
|
-3.74 score on a scale
Standard Deviation 16.36
|
-1.17 score on a scale
Standard Deviation 12.37
|
|
Change in Nicotine Withdrawal Assessment (MNWS)
Depression/Feeling Blue
|
-3.15 score on a scale
Standard Deviation 11.53
|
-2.59 score on a scale
Standard Deviation 7.74
|
-3.24 score on a scale
Standard Deviation 12.43
|
-2.71 score on a scale
Standard Deviation 10.06
|
|
Change in Nicotine Withdrawal Assessment (MNWS)
Desire for Sweets
|
-6.23 score on a scale
Standard Deviation 20.27
|
-1.85 score on a scale
Standard Deviation 17.83
|
-2.15 score on a scale
Standard Deviation 11.32
|
-1.98 score on a scale
Standard Deviation 16.84
|
PRIMARY outcome
Timeframe: Post Smoking SessionPopulation: One participant declined to provide a response during their the high humectant, high sweetness study visit
To determine the relative intensity of specific flavors, e.g., sweetness, the general version of the Labeled Magnitude Scale (gLMS) was used post-smoking session. The scale ranges from 0 to 100 where higher scores indicate that the perception is stronger.
Outcome measures
| Measure |
High Humectant, High Sweetness
n=46 Participants
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
n=46 Participants
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
n=46 Participants
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
n=48 Participants
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Tobacco Flavor Perception (gLMS)
Sweetness
|
10.65 score on a scale
Standard Deviation 9.50
|
9.29 score on a scale
Standard Deviation 10.77
|
9.83 score on a scale
Standard Deviation 11.50
|
11.64 score on a scale
Standard Deviation 11.72
|
|
Tobacco Flavor Perception (gLMS)
Bitterness
|
18.93 score on a scale
Standard Deviation 16.45
|
24.65 score on a scale
Standard Deviation 18.19
|
20.93 score on a scale
Standard Deviation 18.10
|
26.27 score on a scale
Standard Deviation 20.83
|
|
Tobacco Flavor Perception (gLMS)
Smoothness
|
23.20 score on a scale
Standard Deviation 15.84
|
19.54 score on a scale
Standard Deviation 16.36
|
20.70 score on a scale
Standard Deviation 18.40
|
17.52 score on a scale
Standard Deviation 11.34
|
|
Tobacco Flavor Perception (gLMS)
Harshness
|
15.09 score on a scale
Standard Deviation 12.76
|
21.72 score on a scale
Standard Deviation 20.15
|
19.74 score on a scale
Standard Deviation 17.20
|
25.79 score on a scale
Standard Deviation 24.77
|
|
Tobacco Flavor Perception (gLMS)
Coolness
|
10.41 score on a scale
Standard Deviation 12.63
|
10.04 score on a scale
Standard Deviation 14.47
|
8.18 score on a scale
Standard Deviation 9.90
|
7.29 score on a scale
Standard Deviation 9.41
|
PRIMARY outcome
Timeframe: Post Smoking SessionPopulation: One participant declined to provide a response during their the high humectant, high sweetness study visit
To assess the degree of liking or disliking of flavors, will use the Labeled Hedonic Scale (LHS) to collect ratio-level data on the magnitude of liking and disliking of sensation post-smoking session. Scores range from 0 to 100 with higher scores indicating greater liking.
Outcome measures
| Measure |
High Humectant, High Sweetness
n=46 Participants
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
n=46 Participants
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
n=46 Participants
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
n=48 Participants
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Tobacco Flavors Perception, Degree of Liking or Disliking (LHS)
|
37.43 score on a scale
Standard Deviation 12.57
|
32.15 score on a scale
Standard Deviation 13.17
|
34.37 score on a scale
Standard Deviation 14.49
|
30.38 score on a scale
Standard Deviation 14.67
|
PRIMARY outcome
Timeframe: Up to 60 minutesPuff volume measured continuously during the smoking session using the research-grade waterpipe.
Outcome measures
| Measure |
High Humectant, High Sweetness
n=3025 Puffs
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
n=2218 Puffs
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
n=2650 Puffs
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
n=2383 Puffs
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Puffing Topography - Puff Volume
|
0.72 Liters
Standard Deviation 0.48
|
0.63 Liters
Standard Deviation 0.46
|
0.74 Liters
Standard Deviation 0.52
|
0.64 Liters
Standard Deviation 0.47
|
PRIMARY outcome
Timeframe: Up to 60 minutesPuff duration measured continuously during the smoking session using the research-grade waterpipe.
Outcome measures
| Measure |
High Humectant, High Sweetness
n=3025 Puffs
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
n=2218 Puffs
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
n=2650 Puffs
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
n=2383 Puffs
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Puffing Topography - Puff Duration
|
3.43 seconds
Standard Deviation 1.99
|
3.04 seconds
Standard Deviation 1.78
|
3.62 seconds
Standard Deviation 2.28
|
3.19 seconds
Standard Deviation 1.85
|
PRIMARY outcome
Timeframe: Up to 60 minutesPuffing average flow rate measured continuously during the smoking session using the research-grade waterpipe.
Outcome measures
| Measure |
High Humectant, High Sweetness
n=3025 Puffs
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
n=2218 Puffs
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
n=2650 Puffs
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
n=2383 Puffs
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Puffing Topography - Flow Rate
|
12.11 Liters / Minute
Standard Deviation 4.29
|
11.66 Liters / Minute
Standard Deviation 4.50
|
11.81 Liters / Minute
Standard Deviation 3.96
|
11.24 Liters / Minute
Standard Deviation 3.63
|
PRIMARY outcome
Timeframe: Up to 60 minutesPuffing peak flow rate measured continuously during the smoking session using the research-grade waterpipe.
Outcome measures
| Measure |
High Humectant, High Sweetness
n=3025 Puffs
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
n=2218 Puffs
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
n=2650 Puffs
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
n=2383 Puffs
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Puffing Topography - Peak Flow Rate
|
14.57 Liters / Minute
Standard Deviation 5.37
|
13.93 Liters / Minute
Standard Deviation 5.68
|
14.18 Liters / Minute
Standard Deviation 4.92
|
13.37 Liters / Minute
Standard Deviation 4.56
|
PRIMARY outcome
Timeframe: Up to 60 minutesInterpuff interval measured continuously during the smoking session using the research-grade waterpipe.
Outcome measures
| Measure |
High Humectant, High Sweetness
n=3025 Puffs
Tobacco Preparation: High Humectant, High Sweetness
|
High Humectant, Medium Sweetness
n=2218 Puffs
Tobacco Preparation: High Humectant, Medium Sweetness
|
Medium Humectant, High Sweetness
n=2650 Puffs
Tobacco Preparation: Medium Humectant, High Sweetness
|
Medium Humectant, Medium Sweetness
n=2383 Puffs
Tobacco Preparation: Medium Humectant, Medium Sweetness
|
|---|---|---|---|---|
|
Puffing Topography - Interpuff Interval
|
21.01 seconds
Standard Deviation 36.65
|
27.73 seconds
Standard Deviation 53.68
|
23.69 seconds
Standard Deviation 44.55
|
27.90 seconds
Standard Deviation 48.96
|
Adverse Events
High Humectant, High Sweetness
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Humectant, Medium Sweetness
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Medium Humectant, High Sweetness
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Medium Humectant, Medium Sweetness
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Marielle Brinkman
Ohio State University Comprehensive Cancer Center
Phone: 614-688-3226
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place