Smoking
Conditions
Brief summary
The QUIT (Quitting with Usual Care, Incentives, and Technology) Smoking Study is a 3-arm pilot randomized controlled trial that will test the effect of 2 different experimental smoking cessation interventions relative to a control condition in homeless cigarette smokers. All participants will receive free transdermal nicotine patches and weekly in-person smoking cessation counseling. In addition, participants randomized to the first experimental condition will receive financial rewards for biochemically-verified smoking abstinence, and participants randomized to the second experimental condition will be enrolled in a text messaging program to support smoking abstinence.
Interventions
DRUGTransdermal nicotine patch
* ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks * \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
BEHAVIORALIn-person smoking cessation counseling
\- One-on-one 15-minute counseling sessions once per week for 8 weeks
BEHAVIORALContingent financial rewards for smoking abstinence
\- Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide \<8ppm
BEHAVIORALText messages to support smoking abstinence
\- 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT
Sponsors
National Institute on Drug Abuse (NIDA)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Proficient in English, assessed with items asking about native language and self-reported comfort communicating in English among non-native speakers. * Age ≥18 years old, assessed by self-report and verified by date of birth. * Has smoked ≥100 cigarettes and currently smokes ≥5 cigarettes per day, verified by an exhaled carbon monoxide level of ≥8 ppm. * Ready to try quitting smoking within the next month. * Currently homeless, assessed by self-report and defined as usually staying in an emergency shelter, transitional shelter, abandoned building, place of business, car or other vehicle, church or mission, hotel or motel, or anywhere outside during the past 7 days. Additionally, individuals will be considered currently homeless if they usually stayed in somebody else's house, apartment/condominium, or room in the past 7 days because of not having their own place to stay.
Exclusion criteria
* Currently pregnant, assessed by a urine pregnancy test conducted on all premenopausal biologic females who have not had a hysterectomy, or planning to become pregnant in the next 2 months. * Past 30-day use of nicotine replacement therapy, bupropion, or varenicline for smoking cessation, assessed by self-report. Use of bupropion for reasons other than to quit smoking (e.g. depression) is permissible. * Prior serious adverse reaction to the nicotine patch, defined as any reaction that was life-threatening or required hospitalization. * Heart attack or chest pain within the past 2 weeks. * Inability to read a sentence written at a Flesch-Kincaid grade level of 4. * Inability to provide informed consent, assessed with knowledge questions about the material presented during the informed consent process that individuals must correctly answer before providing informed consent to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study period | The primary outcome is a repeated-measures assessment of smoking abstinence, defined as an exhaled carbon monoxide \<8ppm and assessed 14 times over the 8-week study period (3 times/week for the first 2 weeks, 2 times/week for the next 2 weeks, and once every week for the last 4 weeks) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cigarette Consumption | Once per week for 8 weeks | Changes in the average number of cigarettes per day relative to baseline, defined by self-report and repeatedly assessed at the 8 assessment visits occurring on Fridays. |
| Study Visit Attendance | 8 weeks | Percentage of 14 assessment visits attended. |
| Counseling Visit Attendance | 8 weeks | Percentage of 8 counseling visits attended. |
| Nicotine Patch Use | 8 weeks | Days of nicotine replacement therapy use in past week, repeatedly measured at the 8 assessment visits occurring on Fridays. |
| Percentage of Visits Abstinent of Smoking | 8 weeks | Percentage of 14 assessment visits at which a participant is abstinent of smoking, defined as an exhaled carbon monoxide level \<8ppm. |
| Smoking Abstinence at End of Study | 8 weeks | Point-prevalence smoking abstinence, defined as an exhaled carbon monoxide level \<8ppm, at the 14th (final) study visit. |
| Change in Behavioral Health | 4 weeks and 8 weeks | Past-month drug use severity (score range 0-1), past-month alcohol use severity (score range 0-1), and past-month psychiatric severity (0-1) were each assessed with the Addiction Severity Index (ASI) - 5th Edition, at baseline and at the 10th and 14th study visits. For each ASI measure, higher scores represent greater drug, alcohol, or psychiatric severity. Changes in ASI scores between baseline and 4 or 8 weeks can range from -1 to +1. When interpreting changes in scores, negative values indicate decreases in scores from baseline to 4 or 8 weeks, and positive values indicate increases in scores from baseline to 4 or 8 weeks. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Use of Text Messaging Program | 8 weeks | Text messaging group only: number who enrolled in SmokefreeTXT, number who replied to query texts sent by SmokefreeTXT. |
| Recruitment Time | Until target number of participants is reached; anticipate ~6 months | Total time to recruit, enroll, and randomize 75 study participants. |
| Mobile Phone Retention | 8 weeks | Percentage of participants who still have their mobile phone at the end of the study. |
Countries
United States
Participant flow
Pre-assignment details
Some participants (N=8) enrolled in the study but did not return for randomization.
Participants by arm
| Arm | Count |
|---|---|
| Control (N=25) * Transdermal nicotine patch
* In-person smoking cessation counseling
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks | 25 |
| Financial Rewards (N=25) * Transdermal nicotine patch
* In-person smoking cessation counseling
* Contingent financial rewards for smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Contingent financial rewards for smoking abstinence: - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide \<8ppm | 25 |
| Text Messaging (N=25) * Transdermal nicotine patch
* In-person smoking cessation counseling
* Text messages to support smoking abstinence
Transdermal nicotine patch: - ≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
\- \<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks
In-person smoking cessation counseling: - One-on-one 15-minute counseling sessions once per week for 8 weeks
Text messages to support smoking abstinence: - 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT | 25 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Text Messaging (N=25) | Financial Rewards (N=25) | Control (N=25) |
|---|---|---|---|---|
| Age, Continuous | 46.4 years STANDARD_DEVIATION 9.1 | 46.1 years STANDARD_DEVIATION 9.2 | 48.1 years STANDARD_DEVIATION 8.5 | 45.1 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 2 Participants | 6 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants | 23 Participants | 19 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fagerstrom Test for Nicotine Dependence | 5.0 units on a scale STANDARD_DEVIATION 1.9 | 4.9 units on a scale STANDARD_DEVIATION 2 | 5.1 units on a scale STANDARD_DEVIATION 1.9 | 5.1 units on a scale STANDARD_DEVIATION 1.8 |
| Quitting confidence | 6.4 units on a scale STANDARD_DEVIATION 2.4 | 5.9 units on a scale STANDARD_DEVIATION 2.4 | 6.4 units on a scale STANDARD_DEVIATION 2.5 | 6.8 units on a scale STANDARD_DEVIATION 2.2 |
| Quitting importance | 8.8 units on a scale STANDARD_DEVIATION 1.7 | 8.9 units on a scale STANDARD_DEVIATION 1.6 | 8.5 units on a scale STANDARD_DEVIATION 2.1 | 8.8 units on a scale STANDARD_DEVIATION 1.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 3 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants | 11 Participants | 11 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 1 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) White | 31 Participants | 10 Participants | 11 Participants | 10 Participants |
| Region of Enrollment United States | 75 Participants | 25 Participants | 25 Participants | 25 Participants |
| Sex: Female, Male Female | 41 Participants | 15 Participants | 12 Participants | 14 Participants |
| Sex: Female, Male Male | 34 Participants | 10 Participants | 13 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 1 / 25 | 0 / 25 | 5 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
Primary
Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
The primary outcome is a repeated-measures assessment of smoking abstinence, defined as an exhaled carbon monoxide \<8ppm and assessed 14 times over the 8-week study period (3 times/week for the first 2 weeks, 2 times/week for the next 2 weeks, and once every week for the last 4 weeks)
Time frame: Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study period
Population: Participants with missing data at a given time point were assumed non-abstinent at that time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 21 | 2 Participants |
| Control (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 12 | 5 Participants |
| Control (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 42 | 4 Participants |
| Control (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 24 | 2 Participants |
| Control (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 10 | 4 Participants |
| Control (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 35 | 4 Participants |
| Control (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 28 | 4 Participants |
| Control (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 3 | 3 Participants |
| Control (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 14 | 4 Participants |
| Control (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 7 | 4 Participants |
| Control (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 56 | 2 Participants |
| Control (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 17 | 3 Participants |
| Control (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 5 | 0 Participants |
| Control (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 49 | 3 Participants |
| Financial Rewards (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 3 | 10 Participants |
| Financial Rewards (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 10 | 15 Participants |
| Financial Rewards (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 12 | 17 Participants |
| Financial Rewards (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 14 | 15 Participants |
| Financial Rewards (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 17 | 13 Participants |
| Financial Rewards (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 21 | 14 Participants |
| Financial Rewards (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 24 | 17 Participants |
| Financial Rewards (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 28 | 12 Participants |
| Financial Rewards (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 35 | 8 Participants |
| Financial Rewards (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 42 | 11 Participants |
| Financial Rewards (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 49 | 11 Participants |
| Financial Rewards (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 56 | 12 Participants |
| Financial Rewards (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 7 | 15 Participants |
| Financial Rewards (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 5 | 9 Participants |
| Text Messaging (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 42 | 2 Participants |
| Text Messaging (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 17 | 4 Participants |
| Text Messaging (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 10 | 2 Participants |
| Text Messaging (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 49 | 1 Participants |
| Text Messaging (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 14 | 4 Participants |
| Text Messaging (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 7 | 3 Participants |
| Text Messaging (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 56 | 4 Participants |
| Text Messaging (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 12 | 4 Participants |
| Text Messaging (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 28 | 2 Participants |
| Text Messaging (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 24 | 5 Participants |
| Text Messaging (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 5 | 1 Participants |
| Text Messaging (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 35 | 3 Participants |
| Text Messaging (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 21 | 3 Participants |
| Text Messaging (N=25) | Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks | Day 3 | 3 Participants |
Secondary
Change in Behavioral Health
Past-month drug use severity (score range 0-1), past-month alcohol use severity (score range 0-1), and past-month psychiatric severity (0-1) were each assessed with the Addiction Severity Index (ASI) - 5th Edition, at baseline and at the 10th and 14th study visits. For each ASI measure, higher scores represent greater drug, alcohol, or psychiatric severity. Changes in ASI scores between baseline and 4 or 8 weeks can range from -1 to +1. When interpreting changes in scores, negative values indicate decreases in scores from baseline to 4 or 8 weeks, and positive values indicate increases in scores from baseline to 4 or 8 weeks.
Time frame: 4 weeks and 8 weeks
Population: Participants with missing data at a particular time point are excluded from calculation of mean change in ASI scores at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control (N=25) | Change in Behavioral Health | ASI alcohol 4 wk change | -0.02 units on a scale | Standard Deviation 0.12 |
| Control (N=25) | Change in Behavioral Health | ASI alcohol 8 wk change | -0.01 units on a scale | Standard Deviation 0.13 |
| Control (N=25) | Change in Behavioral Health | ASI drug 4 wk change | -0.02 units on a scale | Standard Deviation 0.08 |
| Control (N=25) | Change in Behavioral Health | ASI drug 8 wk change | -0.02 units on a scale | Standard Deviation 0.08 |
| Control (N=25) | Change in Behavioral Health | ASI psychiatric 4 wk change | -0.06 units on a scale | Standard Deviation 0.22 |
| Control (N=25) | Change in Behavioral Health | ASI psychiatric 8 wk change | -0.04 units on a scale | Standard Deviation 0.21 |
| Financial Rewards (N=25) | Change in Behavioral Health | ASI psychiatric 8 wk change | 0.08 units on a scale | Standard Deviation 0.17 |
| Financial Rewards (N=25) | Change in Behavioral Health | ASI alcohol 4 wk change | -0.04 units on a scale | Standard Deviation 0.1 |
| Financial Rewards (N=25) | Change in Behavioral Health | ASI drug 8 wk change | -0.01 units on a scale | Standard Deviation 0.08 |
| Financial Rewards (N=25) | Change in Behavioral Health | ASI psychiatric 4 wk change | -0.04 units on a scale | Standard Deviation 0.13 |
| Financial Rewards (N=25) | Change in Behavioral Health | ASI alcohol 8 wk change | 0.01 units on a scale | Standard Deviation 0.13 |
| Financial Rewards (N=25) | Change in Behavioral Health | ASI drug 4 wk change | -0.04 units on a scale | Standard Deviation 0.07 |
| Text Messaging (N=25) | Change in Behavioral Health | ASI alcohol 8 wk change | -0.04 units on a scale | Standard Deviation 0.14 |
| Text Messaging (N=25) | Change in Behavioral Health | ASI drug 4 wk change | -0.03 units on a scale | Standard Deviation 0.09 |
| Text Messaging (N=25) | Change in Behavioral Health | ASI psychiatric 8 wk change | -0.04 units on a scale | Standard Deviation 0.16 |
| Text Messaging (N=25) | Change in Behavioral Health | ASI drug 8 wk change | 0 units on a scale | Standard Deviation 0.09 |
| Text Messaging (N=25) | Change in Behavioral Health | ASI alcohol 4 wk change | -0.09 units on a scale | Standard Deviation 0.13 |
| Text Messaging (N=25) | Change in Behavioral Health | ASI psychiatric 4 wk change | -0.01 units on a scale | Standard Deviation 0.2 |
Secondary
Change in Cigarette Consumption
Changes in the average number of cigarettes per day relative to baseline, defined by self-report and repeatedly assessed at the 8 assessment visits occurring on Fridays.
Time frame: Once per week for 8 weeks
Population: Participants with missing data at a given time point are excluded from calculation of mean changes in cigarette consumption for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control (N=25) | Change in Cigarette Consumption | Week 6 | -6.2 Cigarettes per day | Standard Deviation 4.2 |
| Control (N=25) | Change in Cigarette Consumption | Week 3 | -8.5 Cigarettes per day | Standard Deviation 5.4 |
| Control (N=25) | Change in Cigarette Consumption | Week 8 | -8.7 Cigarettes per day | Standard Deviation 5.9 |
| Control (N=25) | Change in Cigarette Consumption | Week 5 | -9.4 Cigarettes per day | Standard Deviation 6.4 |
| Control (N=25) | Change in Cigarette Consumption | Week 4 | -8.0 Cigarettes per day | Standard Deviation 5.6 |
| Control (N=25) | Change in Cigarette Consumption | Week 7 | -8.6 Cigarettes per day | Standard Deviation 6.4 |
| Control (N=25) | Change in Cigarette Consumption | Week 2 | -6.7 Cigarettes per day | Standard Deviation 5.8 |
| Control (N=25) | Change in Cigarette Consumption | Week 1 | -5.3 Cigarettes per day | Standard Deviation 6.1 |
| Financial Rewards (N=25) | Change in Cigarette Consumption | Week 5 | -10.2 Cigarettes per day | Standard Deviation 7.2 |
| Financial Rewards (N=25) | Change in Cigarette Consumption | Week 6 | -10.4 Cigarettes per day | Standard Deviation 6.7 |
| Financial Rewards (N=25) | Change in Cigarette Consumption | Week 1 | -8.5 Cigarettes per day | Standard Deviation 6 |
| Financial Rewards (N=25) | Change in Cigarette Consumption | Week 2 | -8.6 Cigarettes per day | Standard Deviation 6.8 |
| Financial Rewards (N=25) | Change in Cigarette Consumption | Week 3 | -12.3 Cigarettes per day | Standard Deviation 10.2 |
| Financial Rewards (N=25) | Change in Cigarette Consumption | Week 4 | -11.1 Cigarettes per day | Standard Deviation 6.9 |
| Financial Rewards (N=25) | Change in Cigarette Consumption | Week 7 | -10.1 Cigarettes per day | Standard Deviation 7.2 |
| Financial Rewards (N=25) | Change in Cigarette Consumption | Week 8 | -7.9 Cigarettes per day | Standard Deviation 5.5 |
| Text Messaging (N=25) | Change in Cigarette Consumption | Week 2 | -7.5 Cigarettes per day | Standard Deviation 6.8 |
| Text Messaging (N=25) | Change in Cigarette Consumption | Week 6 | -5.4 Cigarettes per day | Standard Deviation 5.2 |
| Text Messaging (N=25) | Change in Cigarette Consumption | Week 1 | -6.0 Cigarettes per day | Standard Deviation 7.2 |
| Text Messaging (N=25) | Change in Cigarette Consumption | Week 8 | -5.4 Cigarettes per day | Standard Deviation 3.7 |
| Text Messaging (N=25) | Change in Cigarette Consumption | Week 7 | -8.1 Cigarettes per day | Standard Deviation 8 |
| Text Messaging (N=25) | Change in Cigarette Consumption | Week 5 | -7.9 Cigarettes per day | Standard Deviation 7 |
| Text Messaging (N=25) | Change in Cigarette Consumption | Week 4 | -9.5 Cigarettes per day | Standard Deviation 7.2 |
| Text Messaging (N=25) | Change in Cigarette Consumption | Week 3 | -7.7 Cigarettes per day | Standard Deviation 7.2 |
Secondary
Counseling Visit Attendance
Percentage of 8 counseling visits attended.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control (N=25) | Counseling Visit Attendance | 17.0 percentage of visits | Standard Deviation 21.3 |
| Financial Rewards (N=25) | Counseling Visit Attendance | 10.5 percentage of visits | Standard Deviation 12.8 |
| Text Messaging (N=25) | Counseling Visit Attendance | 17.0 percentage of visits | Standard Deviation 21 |
Secondary
Nicotine Patch Use
Days of nicotine replacement therapy use in past week, repeatedly measured at the 8 assessment visits occurring on Fridays.
Time frame: 8 weeks
Population: Participants with missing data at a given time point were excluded from calculation of mean past-week patch use at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control (N=25) | Nicotine Patch Use | Week 1 | 3.7 Days | Standard Deviation 2.7 |
| Control (N=25) | Nicotine Patch Use | Week 2 | 4.9 Days | Standard Deviation 2.8 |
| Control (N=25) | Nicotine Patch Use | Week 3 | 4.4 Days | Standard Deviation 2.9 |
| Control (N=25) | Nicotine Patch Use | Week 4 | 4.3 Days | Standard Deviation 3 |
| Control (N=25) | Nicotine Patch Use | Week 5 | 4.4 Days | Standard Deviation 2.7 |
| Control (N=25) | Nicotine Patch Use | Week 6 | 3.5 Days | Standard Deviation 2.8 |
| Control (N=25) | Nicotine Patch Use | Week 7 | 4.3 Days | Standard Deviation 2.8 |
| Control (N=25) | Nicotine Patch Use | Week 8 | 3.6 Days | Standard Deviation 3.1 |
| Financial Rewards (N=25) | Nicotine Patch Use | Week 3 | 4.9 Days | Standard Deviation 2.2 |
| Financial Rewards (N=25) | Nicotine Patch Use | Week 7 | 4.6 Days | Standard Deviation 2.5 |
| Financial Rewards (N=25) | Nicotine Patch Use | Week 4 | 3.6 Days | Standard Deviation 2.8 |
| Financial Rewards (N=25) | Nicotine Patch Use | Week 5 | 4.6 Days | Standard Deviation 2.8 |
| Financial Rewards (N=25) | Nicotine Patch Use | Week 6 | 4.0 Days | Standard Deviation 3 |
| Financial Rewards (N=25) | Nicotine Patch Use | Week 1 | 4.1 Days | Standard Deviation 2.6 |
| Financial Rewards (N=25) | Nicotine Patch Use | Week 2 | 4.5 Days | Standard Deviation 2.6 |
| Financial Rewards (N=25) | Nicotine Patch Use | Week 8 | 3.9 Days | Standard Deviation 2.9 |
| Text Messaging (N=25) | Nicotine Patch Use | Week 3 | 4.9 Days | Standard Deviation 2.9 |
| Text Messaging (N=25) | Nicotine Patch Use | Week 2 | 4.5 Days | Standard Deviation 2.9 |
| Text Messaging (N=25) | Nicotine Patch Use | Week 1 | 4.5 Days | Standard Deviation 2.9 |
| Text Messaging (N=25) | Nicotine Patch Use | Week 4 | 4.4 Days | Standard Deviation 2.8 |
| Text Messaging (N=25) | Nicotine Patch Use | Week 7 | 3.8 Days | Standard Deviation 2.6 |
| Text Messaging (N=25) | Nicotine Patch Use | Week 6 | 4.1 Days | Standard Deviation 2.7 |
| Text Messaging (N=25) | Nicotine Patch Use | Week 5 | 4.9 Days | Standard Deviation 2.5 |
| Text Messaging (N=25) | Nicotine Patch Use | Week 8 | 2.7 Days | Standard Deviation 2.9 |
Secondary
Percentage of Visits Abstinent of Smoking
Percentage of 14 assessment visits at which a participant is abstinent of smoking, defined as an exhaled carbon monoxide level \<8ppm.
Time frame: 8 weeks
Population: Participants with missing data at a given time point were assumed non-abstinent at that time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control (N=25) | Percentage of Visits Abstinent of Smoking | 12.6 percentage of visits | Standard Deviation 22.1 |
| Financial Rewards (N=25) | Percentage of Visits Abstinent of Smoking | 51.1 percentage of visits | Standard Deviation 32.8 |
| Text Messaging (N=25) | Percentage of Visits Abstinent of Smoking | 11.7 percentage of visits | Standard Deviation 21.9 |
Secondary
Smoking Abstinence at End of Study
Point-prevalence smoking abstinence, defined as an exhaled carbon monoxide level \<8ppm, at the 14th (final) study visit.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control (N=25) | Smoking Abstinence at End of Study | 2 Participants |
| Financial Rewards (N=25) | Smoking Abstinence at End of Study | 12 Participants |
| Text Messaging (N=25) | Smoking Abstinence at End of Study | 4 Participants |
Secondary
Study Visit Attendance
Percentage of 14 assessment visits attended.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control (N=25) | Study Visit Attendance | 65.4 percentage of visits | Standard Deviation 32.2 |
| Financial Rewards (N=25) | Study Visit Attendance | 71.1 percentage of visits | Standard Deviation 24.3 |
| Text Messaging (N=25) | Study Visit Attendance | 65.7 percentage of visits | Standard Deviation 27 |
Other Pre-specified
Mobile Phone Retention
Percentage of participants who still have their mobile phone at the end of the study.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control (N=25) | Mobile Phone Retention | 13 Participants |
| Financial Rewards (N=25) | Mobile Phone Retention | 15 Participants |
| Text Messaging (N=25) | Mobile Phone Retention | 10 Participants |
Other Pre-specified
Recruitment Time
Total time to recruit, enroll, and randomize 75 study participants.
Time frame: Until target number of participants is reached; anticipate ~6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control (N=25) | Recruitment Time | 6 months |
| Financial Rewards (N=25) | Recruitment Time | 6 months |
| Text Messaging (N=25) | Recruitment Time | 6 months |
Other Pre-specified
Use of Text Messaging Program
Text messaging group only: number who enrolled in SmokefreeTXT, number who replied to query texts sent by SmokefreeTXT.
Time frame: 8 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Text Messaging (N=25) | Use of Text Messaging Program | Enrolled in SmokefreeTXT | 22 Participants |
| Text Messaging (N=25) | Use of Text Messaging Program | Replied to texts from SmokefreeTXT | 7 Participants |