Cigarette Smoking-Related Carcinoma
Conditions
Brief summary
This clinical trial collects data to see how filter ventilation and ventilation information affects product use behaviors in cigarette smokers. Providing ventilation information on the cigarette package may affect smokers' rating of product appeal, perceptions of health risk, and changes in cigarette consumption.
Detailed description
PRIMARY OBJECTIVE: I. To assess how adding messaging to cigarette packages about filter vents and filters influences respondents awareness of filter ventilation, beliefs about the function of filter vents and filters, smoking behavior, ratings of cigarette satisfaction, smoking topography, exposure to nicotine and carbon monoxide, perceptions about the risk of smoking, and intention to stop smoking. OUTLINE: Participants are randomized to 1 of 4 conditions. CONDITION I: Participants receive regular package cigarettes for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection. CONDITION II: Participants receive cigarettes with neutral message Nothing about this product's color or name means that it will protect a smoker from the health risks of smoking on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection. CONDITION III: Participants receive cigarettes with compensation message This product has a ventilated filter. Filter vents increase how deeply a smoker inhales without them knowing, which can increase the health risks of smoking on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection. CONDITION IV: Participants receive cigarettes with blocking message This product has a ventilated filter. Be sure not to block the vent holes with your fingers or lips, which can increase the health risks of smoking for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.
Interventions
OTHERCigarette packaging
receive normal packet cigarette
OTHERData capture
Attend video sessions
OTHERQuestionnaire administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 21-69 years old * Currently smoking daily, at least 5 cigarettes per day, for the past year: \* Primarily using factory-made filtered cigarettes * Fair and above self-rated physical health (self-rated) * Fair and above self-rated mental health (self-rated) * Not planning to quit smoking in the next 30 days * Able to converse, read, and write in English * Access to smartphone (e.g., iPhone, Android) for Ecological Momentary Assessment (EMA) component * Access to a smartphone/tablet/computer with video capabilities and internet access for remote videoconferencing (EMA check-ins) * Alcohol Use Disorders Identification Test (AUDIT)-C \<7 (i.e., no problematic alcohol consumption) * Cannibis use less than or equal to 5 days in the past month * No other illegal drug use in the past month (allow for prescription) * Not pregnant or breastfeeding or planning to become pregnant during the study period * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion criteria
* Age \< 21 or \> 69 * Using roll-your-own cigarettes or usual brand of cigarettes is unfiltered * Planning to quit smoking in the next 30 days * Adults unable to consent * Minors (any persons under age 21) * Prisoners * Poor physical health by self-report * Poor mental health by self-report: \* Exclude Dx psychosis, Dx bipolar, K6 score indicating serious psychological distress * AUDIT-C score \>=7 (i.e. problematic alcohol consumption) * Cannabis use \>5 days in past month * Other illegal drug use in past month * Pregnant or breastfeeding by self-report * No access to smartphone or videoconferencing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Questionnaires of Product Evaluation | At 2 weeks | Will be assessed by Duke Sensory Scale. A 9 item questionnaire with nine items that assess participants' sensory experience All questions are rated on a 7-point Likert scale (with 1 meaning -not at all to 7 - meaning extremely). |
| Readiness to Quit | At 2 weeks | Will be assessed by contemplation ladder. This is a 0 to 10 scale, where 0 indicates no willingness/readiness to quit and 10 indicates willing/ready to quit immediately. |
| Withdrawal | At 2 weeks | Will be assessed by Minnesota Tobacco Withdrawal Scale - a 15 item question scale - with scale of 0 -4, 0=Not at all - 4=Severe. A total score is obtained by summing all 15 items. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Exhaled Carbon Monoxide (CO) | At 2 weeks | level of CO measured in exhaled breath after a 15 seconds breathhold |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Condition 1 (Normal Cigarettes) Participants receive regular package cigarettes for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies | 30 |
| Condition II (Cigarettes With Neutral Message) Participants receive cigarettes with neutral message Nothing about this product's color or name means that it will protect a smoker from the health risks of smoking on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies | 28 |
| Condition III (Cigarettes With Compensation Message) Participants receive cigarettes with compensation message This product has a ventilated filter. Filter vents increase how deeply a smoker inhales without them knowing, which can increase the health risks of smoking on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies | 31 |
| Condition IV Cigarettes With Blocking Message Participants receive cigarettes with blocking message This product has a ventilated filter. Be sure not to block the vent holes with your fingers or lips, which can increase the health risks of smoking for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection
Cigarette packaging: receive normal packet cigarette
Data capture: Attend video sessions
Questionnaire administration: Ancillary studies | 21 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 | 2 | 1 |
Baseline characteristics
| Characteristic | Condition 1 (Normal Cigarettes) | Condition II (Cigarettes With Neutral Message) | Condition III (Cigarettes With Compensation Message) | Condition IV Cigarettes With Blocking Message | Total |
|---|---|---|---|---|---|
| Age, Customized < 18 years old | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >= 18 years old | 30 Participants | 28 Participants | 31 Participants | 21 Participants | 110 Participants |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment United States | 30 participants | 28 participants | 31 participants | 21 participants | 110 participants |
| Sex: Female, Male Female | 23 Participants | 22 Participants | 19 Participants | 19 Participants | 83 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 12 Participants | 2 Participants | 27 Participants |
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 / 30 | 0 / 28 | 0 / 31 | 0 / 21 |
| other Total, other adverse events | 0 / 30 | 0 / 28 | 0 / 31 | 0 / 21 |
| serious Total, serious adverse events | 0 / 30 | 0 / 28 | 0 / 31 | 0 / 21 |
Outcome results
Primary
Readiness to Quit
Will be assessed by contemplation ladder. This is a 0 to 10 scale, where 0 indicates no willingness/readiness to quit and 10 indicates willing/ready to quit immediately.
Time frame: At 2 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Condition 1 (Normal Cigarettes) | Readiness to Quit | 6.27 score on a scale |
| Condition II (Cigarettes With Neutral Message) | Readiness to Quit | 5.79 score on a scale |
| Condition III (Cigarettes With Compensation Message) | Readiness to Quit | 6.58 score on a scale |
| Condition IV Cigarettes With Blocking Message | Readiness to Quit | 6.24 score on a scale |
Primary
Subjective Questionnaires of Product Evaluation
Will be assessed by Duke Sensory Scale. A 9 item questionnaire with nine items that assess participants' sensory experience All questions are rated on a 7-point Likert scale (with 1 meaning -not at all to 7 - meaning extremely).
Time frame: At 2 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Condition 1 (Normal Cigarettes) | Subjective Questionnaires of Product Evaluation | How much did you like the puffs you just took? | 4.27 units on a scale |
| Condition 1 (Normal Cigarettes) | Subjective Questionnaires of Product Evaluation | Strength of puffs on tongue | 4.03 units on a scale |
| Condition 1 (Normal Cigarettes) | Subjective Questionnaires of Product Evaluation | How satisfying were the puffs you just took? | 4.27 units on a scale |
| Condition 1 (Normal Cigarettes) | Subjective Questionnaires of Product Evaluation | Strength of puffs in back of mouth and throat | 4.1 units on a scale |
| Condition 1 (Normal Cigarettes) | Subjective Questionnaires of Product Evaluation | Strength of puffs in chest | 4.07 units on a scale |
| Condition 1 (Normal Cigarettes) | Subjective Questionnaires of Product Evaluation | Strength of puffs in nose | 3.4 units on a scale |
| Condition 1 (Normal Cigarettes) | Subjective Questionnaires of Product Evaluation | How similar to your own brand were the puffs? | 3.33 units on a scale |
| Condition 1 (Normal Cigarettes) | Subjective Questionnaires of Product Evaluation | How high in nicotine do you think the puffs were? | 4.33 units on a scale |
| Condition 1 (Normal Cigarettes) | Subjective Questionnaires of Product Evaluation | Strength of puffs in windpipe | 4.13 units on a scale |
| Condition II (Cigarettes With Neutral Message) | Subjective Questionnaires of Product Evaluation | How much did you like the puffs you just took? | 3.86 units on a scale |
| Condition II (Cigarettes With Neutral Message) | Subjective Questionnaires of Product Evaluation | How satisfying were the puffs you just took? | 3.82 units on a scale |
| Condition II (Cigarettes With Neutral Message) | Subjective Questionnaires of Product Evaluation | How high in nicotine do you think the puffs were? | 4.11 units on a scale |
| Condition II (Cigarettes With Neutral Message) | Subjective Questionnaires of Product Evaluation | Strength of puffs on tongue | 3.86 units on a scale |
| Condition II (Cigarettes With Neutral Message) | Subjective Questionnaires of Product Evaluation | How similar to your own brand were the puffs? | 3.54 units on a scale |
| Condition II (Cigarettes With Neutral Message) | Subjective Questionnaires of Product Evaluation | Strength of puffs in nose | 3.21 units on a scale |
| Condition II (Cigarettes With Neutral Message) | Subjective Questionnaires of Product Evaluation | Strength of puffs in back of mouth and throat | 3.54 units on a scale |
| Condition II (Cigarettes With Neutral Message) | Subjective Questionnaires of Product Evaluation | Strength of puffs in windpipe | 3.61 units on a scale |
| Condition II (Cigarettes With Neutral Message) | Subjective Questionnaires of Product Evaluation | Strength of puffs in chest | 3.32 units on a scale |
| Condition III (Cigarettes With Compensation Message) | Subjective Questionnaires of Product Evaluation | How satisfying were the puffs you just took? | 4.35 units on a scale |
| Condition III (Cigarettes With Compensation Message) | Subjective Questionnaires of Product Evaluation | How much did you like the puffs you just took? | 4.16 units on a scale |
| Condition III (Cigarettes With Compensation Message) | Subjective Questionnaires of Product Evaluation | Strength of puffs in chest | 3.84 units on a scale |
| Condition III (Cigarettes With Compensation Message) | Subjective Questionnaires of Product Evaluation | Strength of puffs in windpipe | 4.0 units on a scale |
| Condition III (Cigarettes With Compensation Message) | Subjective Questionnaires of Product Evaluation | Strength of puffs in nose | 3.03 units on a scale |
| Condition III (Cigarettes With Compensation Message) | Subjective Questionnaires of Product Evaluation | How similar to your own brand were the puffs? | 3.77 units on a scale |
| Condition III (Cigarettes With Compensation Message) | Subjective Questionnaires of Product Evaluation | Strength of puffs on tongue | 3.61 units on a scale |
| Condition III (Cigarettes With Compensation Message) | Subjective Questionnaires of Product Evaluation | How high in nicotine do you think the puffs were? | 4.65 units on a scale |
| Condition III (Cigarettes With Compensation Message) | Subjective Questionnaires of Product Evaluation | Strength of puffs in back of mouth and throat | 4.13 units on a scale |
| Condition IV Cigarettes With Blocking Message | Subjective Questionnaires of Product Evaluation | How high in nicotine do you think the puffs were? | 4.43 units on a scale |
| Condition IV Cigarettes With Blocking Message | Subjective Questionnaires of Product Evaluation | Strength of puffs in windpipe | 4.19 units on a scale |
| Condition IV Cigarettes With Blocking Message | Subjective Questionnaires of Product Evaluation | How similar to your own brand were the puffs? | 3.33 units on a scale |
| Condition IV Cigarettes With Blocking Message | Subjective Questionnaires of Product Evaluation | Strength of puffs in chest | 4.10 units on a scale |
| Condition IV Cigarettes With Blocking Message | Subjective Questionnaires of Product Evaluation | Strength of puffs in back of mouth and throat | 4.14 units on a scale |
| Condition IV Cigarettes With Blocking Message | Subjective Questionnaires of Product Evaluation | How much did you like the puffs you just took? | 4.9 units on a scale |
| Condition IV Cigarettes With Blocking Message | Subjective Questionnaires of Product Evaluation | Strength of puffs on tongue | 3.76 units on a scale |
| Condition IV Cigarettes With Blocking Message | Subjective Questionnaires of Product Evaluation | Strength of puffs in nose | 2.95 units on a scale |
| Condition IV Cigarettes With Blocking Message | Subjective Questionnaires of Product Evaluation | How satisfying were the puffs you just took? | 4.95 units on a scale |
Primary
Withdrawal
Will be assessed by Minnesota Tobacco Withdrawal Scale - a 15 item question scale - with scale of 0 -4, 0=Not at all - 4=Severe. A total score is obtained by summing all 15 items.
Time frame: At 2 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Condition 1 (Normal Cigarettes) | Withdrawal | 13.2 score on a scale |
| Condition II (Cigarettes With Neutral Message) | Withdrawal | 12.3 score on a scale |
| Condition III (Cigarettes With Compensation Message) | Withdrawal | 8.8 score on a scale |
| Condition IV Cigarettes With Blocking Message | Withdrawal | 13.9 score on a scale |
Secondary
Level of Exhaled Carbon Monoxide (CO)
level of CO measured in exhaled breath after a 15 seconds breathhold
Time frame: At 2 weeks
Population: This outcome data was only measured on a random subset of participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Condition 1 (Normal Cigarettes) | Level of Exhaled Carbon Monoxide (CO) | 21.3 parts per million | Standard Deviation 11 |
| Condition II (Cigarettes With Neutral Message) | Level of Exhaled Carbon Monoxide (CO) | 15.0 parts per million | Standard Deviation 10.7 |
| Condition III (Cigarettes With Compensation Message) | Level of Exhaled Carbon Monoxide (CO) | 22.6 parts per million | Standard Deviation 16.6 |
| Condition IV Cigarettes With Blocking Message | Level of Exhaled Carbon Monoxide (CO) | 27.6 parts per million | Standard Deviation 33.6 |