Tobacco Use Disorder
Conditions
Brief summary
The study is a randomized crossover trial. Current smokers will complete a session with each product: usual brand cigarette, e-cigarette, and heat-not-burn. The objective of this survey is to assess for ongoing use of study products and is part of safety monitoring.
Detailed description
The study is a randomized crossover trial. Current smokers will be randomized to session order and complete a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with each product (usual brand cigarette, e-cigarette, heat-not-burn). Throughout each visit, blood will be collected for nicotine analysis via an IV catheter placed in the patient's arm. Blood samples will be aliquoted into two separate vials. One will be analyzed for the current study and one will be placed in a biospecimen repository if participant provides consent for biorepository. Puff topography will be collected passively throughout the session to measure puffing patterns. Participants will complete self-report measures of nicotine withdrawal and craving. Finally, breath samples will be collected to measure changes in exhaled carbon monoxide, a potent lung toxicant, pre- and post-product use. At the final visit, participants will complete a behavioral economics concurrent choice task (see below for description) to behaviorally measure their decisions regarding use of e-cigarettes or heat not burn products in place of cigarettes. Finally, participants will be contacted by phone 6 months following the conclusion of visit 3 (or study discontinuation) to complete a phone survey. The objective of this survey is to assess for ongoing use of study products and is part of safety monitoring. We have no hypotheses related to the follow-up.
Interventions
COMBINATION_PRODUCTE-cigarette and Heat not burn
Current smokers will be randomized to session order and complete a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with each product (usual brand cigarette, e-cigarette, heat-not-burn).
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
1. 20 eligible African American and white smokers will be randomized. A 1:1 randomization to product order (combustible cigarette, e-cigarette, heat-not-burn vs. combustible cigarette, heat-not-burn, e-cigarette). Randomization will be determined by computer-generated random numbers. Randomization assignments will be placed in sealed envelopes with sequential study identification numbers. After baseline data collection has been completed, the research assistant will select the sequential study identification number to determine the randomization assignment 2. No blinding is involved. 3. Due to the pilot nature of the current study, formal power calculations were not conducted. ANOVAs will be conducted to detect within-subject differences between products. A Bonferroni correction will be applied to adjust for multiple comparisons.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Non-Hispanic African American or white/Caucasian, * ≥21 years old, smoke 5-30 cigarettes per day, * daily cigarette smoker * smoked at current rate for at least 6 months * interested in trying e-cigarettes and heat not burn products * not interested in or unable/unwilling to quit cigarette smoking * willing to complete three in-person study visits * willing to have IV catheter placed
Exclusion criteria
* Interested in quitting cigarettes in the next 30 days * use of smoking cessation pharmacotherapy in the past 30 days * use of non-cigarette tobacco products in the past 30 days * use of e-cigarettes \>5x in lifetime * use of e-cigarettes ≥4 of the past 30 days * use of heat not burn products \>5x in lifetime * use of heat not burn products ≥4 of the past 30 days * weight \< 110 lbs * uncontrolled hypertension (systolic BP ≥ 180 or diastolic BP ≥ 105) * pregnant, plans to become pregnant, or breastfeeding * live \>10 miles from study site (Fairway CRU) * current enrollment is a research study or program that aims to alter tobacco use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nicotine Delivery | Baseline, after 10 puff bout of product at 5 minutes | Blood plasma nicotine concentration after 10 puff bout of product at 5 minutes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cigarette, E-Cigarette Then Heat Not Burn. At lab visit 1 participants receive their usual brand cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session.
Following at least a 48-hour washout period, at lab visit 2, participants receive electronic cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session.
Following at least a 48-hour washout period, at lab visit 3, participants receive Heat Not Burn during the 10-puff standardized puff bout and 60-minute ad libitum session. | 11 |
| Cigarette, Heat Not Burn Then E-Cigarette At lab visit 1 participants receive their usual brand cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session.
Following at least a 48-hour washout period, at lab visit 2, participants receive Heat Not Burn during the 10-puff standardized puff bout and 60-minute ad libitum session.
Following at least a 48-hour washout period, at lab visit 3, participants receive electronic cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session. | 11 |
| Total | 22 |
Baseline characteristics
| Characteristic | Cigarette, E-Cigarette Then Heat Not Burn. | Total | Cigarette, Heat Not Burn Then E-Cigarette |
|---|---|---|---|
| Age, Continuous | 53.5 years | 54.1 years | 54.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 22 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 12 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 10 Participants | 5 Participants |
| Region of Enrollment United States | 11 participants | 22 participants | 11 participants |
| Sex: Female, Male Female | 4 Participants | 13 Participants | 9 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 22 |
Outcome results
Primary
Nicotine Delivery
Blood plasma nicotine concentration after 10 puff bout of product at 5 minutes
Time frame: Baseline, after 10 puff bout of product at 5 minutes
Population: Blood plasma nicotine concentration 5 minutes after start
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cigarette | Nicotine Delivery | 14.13 ng/mL |
| E-Cigarette | Nicotine Delivery | 6.79 ng/mL |
| Heat Not Burn | Nicotine Delivery | 9.15 ng/mL |
Comparison: The null hypothesis is that there is no difference in nicotine delivery between cigarettes, e-cigarettes, and heat not burn after the standardized 10-puff bout. ANOVAs were conducted to detect differences between products for nicotine concentration at five minutes (immediately following 10-puff bout). The test was performed with a significance level of 0.05 (two-sided).p-value: 0.002ANOVA