Smoking, Hookah, Waterpipe Smoking
Conditions
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.
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.
Interventions
BEHAVIORALFlavored-Sweetened Waterpipe Tobacco
Pre-weighed flavored-sweetened waterpipe tobacco will be prepared.
BEHAVIORALUnflavored-sweetened waterpipe tobacco
Pre-weighed unflavored-sweetened waterpipe tobacco will be prepared.
BEHAVIORALUnflavored-very low sweetened waterpipe tobacco
Pre-weighed unflavored-very low sweetened waterpipe tobacco will be prepared.
BEHAVIORALFlavored-very low sweetened waterpipe
Pre-weighed flavored-very low sweetened waterpipe tobacco will be prepared.
Sponsors
Virginia Commonwealth University
American University of Beirut Medical Center
National Institute on Drug Abuse (NIDA)
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of Smoke Inhalation Measured by Topography Device | 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Levels of Smoke Inhalation Between High vs. Low Dependent WP | 6 months | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Study 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. | 89 |
| Total | 89 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 23.98 years STANDARD_DEVIATION 5.58 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 48 Participants |
| Region of Enrollment United States | 89 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 53 Participants |
| Waterpipe dependence High Dependence | 39 Participants |
| Waterpipe dependence Low Dependence | 50 Participants |
| Waterpipe smoking days per month | 6.5 Days STANDARD_DEVIATION 8.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 86 | 0 / 66 | 0 / 66 |
| other Total, other adverse events | 0 / 80 | 0 / 86 | 0 / 66 | 0 / 66 |
| serious Total, serious adverse events | 0 / 80 | 0 / 86 | 0 / 66 | 0 / 66 |
Outcome results
Primary
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).
Time frame: 6 months
Population: 1 participant was not included in analysis due to self-withdraw. Participants who completed one or more of the individual intervention visits were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flavored-sweetened | Level of Smoke Inhalation Measured by Topography Device | 50.96 Liters | Standard Error 5.46 |
| Unflavored-sweetened | Level of Smoke Inhalation Measured by Topography Device | 77.79 Liters | Standard Error 5.89 |
| Unflavored Very Low Sweetened | Level of Smoke Inhalation Measured by Topography Device | 63.17 Liters | Standard Error 5.87 |
| Flavored-very Low Sweetened Waterpipe | Level of Smoke Inhalation Measured by Topography Device | 51.60 Liters | Standard Error 4.63 |
Secondary
Levels of Smoke Inhalation Between High vs. Low Dependent WP
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
Time frame: 6 months
Population: 1 participant was not included in analysis due to self-withdraw. Participants who completed one or more of the individual intervention visits were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flavored-sweetened | Levels of Smoke Inhalation Between High vs. Low Dependent WP | Low Dependence | 42.18 Liters | Standard Error 5.02 |
| Flavored-sweetened | Levels of Smoke Inhalation Between High vs. Low Dependent WP | High Dependence | 32.15 Liters | Standard Error 6.26 |
| Unflavored-sweetened | Levels of Smoke Inhalation Between High vs. Low Dependent WP | High Dependence | 57.31 Liters | Standard Error 6.95 |
| Unflavored-sweetened | Levels of Smoke Inhalation Between High vs. Low Dependent WP | Low Dependence | 55.85 Liters | Standard Error 5.84 |
| Unflavored Very Low Sweetened | Levels of Smoke Inhalation Between High vs. Low Dependent WP | High Dependence | 51.07 Liters | Standard Error 7.26 |
| Unflavored Very Low Sweetened | Levels of Smoke Inhalation Between High vs. Low Dependent WP | Low Dependence | 46.18 Liters | Standard Error 6.03 |
| Flavored-very Low Sweetened Waterpipe | Levels of Smoke Inhalation Between High vs. Low Dependent WP | High Dependence | 33.96 Liters | Standard Error 5.01 |
| Flavored-very Low Sweetened Waterpipe | Levels of Smoke Inhalation Between High vs. Low Dependent WP | Low Dependence | 39.43 Liters | Standard Error 4.54 |