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| ID | Type | Description | Link |
|---|---|---|---|
| K23DA034008 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (N=25) | Active Comparator |
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| Financial rewards (N=25) | Experimental |
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| Text messaging (N=25) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdermal nicotine patch | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Smoking Abstinence at End of Study |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Time | Total time to recruit, enroll, and randomize 75 study participants. | Until target number of participants is reached; anticipate ~6 months |
| Mobile Phone Retention | Percentage of participants who still have their mobile phone at the end of the study. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Travis P Baggett, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Health Care for the Homeless Program | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31165717 | Derived | Baggett TP, McGlave C, Kruse GR, Yaqubi A, Chang Y, Rigotti NA. SmokefreeTXT for Homeless Smokers: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 4;7(6):e13162. doi: 10.2196/13162. | |
| 29631559 | Derived | Baggett TP, Yaqubi A, Berkowitz SA, Kalkhoran SM, McGlave C, Chang Y, Campbell EG, Rigotti NA. Subsistence difficulties are associated with more barriers to quitting and worse abstinence outcomes among homeless smokers: evidence from two studies in Boston, Massachusetts. BMC Public Health. 2018 Apr 10;18(1):463. doi: 10.1186/s12889-018-5375-z. |
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Some participants (N=8) enrolled in the study but did not return for randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control (N=25) |
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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| In-person smoking cessation counseling | Behavioral | - One-on-one 15-minute counseling sessions once per week for 8 weeks |
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| Contingent financial rewards for smoking abstinence | Behavioral | - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm |
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| Text messages to support smoking abstinence | Behavioral | - 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 |
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Point-prevalence smoking abstinence, defined as an exhaled carbon monoxide level <8ppm, at the 14th (final) study visit.
| 8 weeks |
| 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. | Once per week for 8 weeks |
| 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. | 4 weeks and 8 weeks |
| Study Visit Attendance | Percentage of 14 assessment visits attended. | 8 weeks |
| Counseling Visit Attendance | Percentage of 8 counseling visits attended. | 8 weeks |
| Nicotine Patch Use | Days of nicotine replacement therapy use in past week, repeatedly measured at the 8 assessment visits occurring on Fridays. | 8 weeks |
| 8 weeks |
| Use of Text Messaging Program | Text messaging group only: number who enrolled in SmokefreeTXT, number who replied to query texts sent by SmokefreeTXT. | 8 weeks |
| 29059442 | Derived | Baggett TP, Chang Y, Yaqubi A, McGlave C, Higgins ST, Rigotti NA. Financial Incentives for Smoking Abstinence in Homeless Smokers: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2018 Nov 15;20(12):1442-1450. doi: 10.1093/ntr/ntx178. |
| FG001 | Financial Rewards (N=25) |
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 |
| FG002 | Text Messaging (N=25) |
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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control (N=25) |
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 |
| BG001 | Financial Rewards (N=25) |
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 |
| BG002 | Text Messaging (N=25) |
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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Fagerstrom Test for Nicotine Dependence | Score range is 0-10, with higher scores indicating greater nicotine dependence. | Mean | Standard Deviation | units on a scale |
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| Quitting confidence | 1-10 visual scale of confidence to quit, with higher scores indicating greater confidence to quit smoking. | Mean | Standard Deviation | units on a scale |
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| Quitting importance | 1-10 visual scale of importance of quitting, with higher scores indicating greater importance of quitting smoking. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Participants with missing data at a given time point were assumed non-abstinent at that time point. | Posted | Count of Participants | Participants | Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study period |
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| 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. | Participants with missing data at a given time point were assumed non-abstinent at that time point. | Posted | Mean | Standard Deviation | percentage of visits | 8 weeks |
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| 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. | Posted | Count of Participants | Participants | 8 weeks |
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| 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. | Participants with missing data at a given time point are excluded from calculation of mean changes in cigarette consumption for that time point. | Posted | Mean | Standard Deviation | Cigarettes per day | Once per week for 8 weeks |
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| 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. | Participants with missing data at a particular time point are excluded from calculation of mean change in ASI scores at that time point. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks and 8 weeks |
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| Secondary | Study Visit Attendance | Percentage of 14 assessment visits attended. | Posted | Mean | Standard Deviation | percentage of visits | 8 weeks |
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| Secondary | Counseling Visit Attendance | Percentage of 8 counseling visits attended. | Posted | Mean | Standard Deviation | percentage of visits | 8 weeks |
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| Secondary | Nicotine Patch Use | Days of nicotine replacement therapy use in past week, repeatedly measured at the 8 assessment visits occurring on Fridays. | Participants with missing data at a given time point were excluded from calculation of mean past-week patch use at that time point. | Posted | Mean | Standard Deviation | Days | 8 weeks |
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| Other Pre-specified | Recruitment Time | Total time to recruit, enroll, and randomize 75 study participants. | Posted | Number | months | Until target number of participants is reached; anticipate ~6 months |
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| Other Pre-specified | Mobile Phone Retention | Percentage of participants who still have their mobile phone at the end of the study. | Posted | Count of Participants | Participants | 8 weeks |
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| 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. | Posted | Count of Participants | Participants | 8 weeks |
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Adverse event data were collected during the 8-week study period for each participant.
Participants were asked about adverse events at each of the 14 follow-up visits over 8 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control (N=25) |
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 | 0 | 25 | 0 | 25 | 1 | 25 |
| EG001 | Financial Rewards (N=25) |
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 | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Text Messaging (N=25) |
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 | 0 | 25 | 0 | 25 | 5 | 25 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea/vomiting | Gastrointestinal disorders | Systematic Assessment | Nausea or vomiting correlated with nicotine patch use |
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| Rash at nicotine patch site | Skin and subcutaneous tissue disorders | Systematic Assessment | Rash at nicotine patch site |
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| Dizziness | Nervous system disorders | Systematic Assessment | Dizziness correlated with nicotine patch use |
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| Sweating | General disorders | Systematic Assessment | Sweatiness correlated with nicotine patch use |
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| Headache | General disorders | Systematic Assessment | Headache correlated with nicotine patch use |
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| Fatigue | General disorders | Systematic Assessment | Fatigue correlated with nicotine patch use |
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Small sample size; short duration of follow-up; primary outcome based exclusively on exhaled carbon monoxide measurement.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Travis P. Baggett, MD, MPH (Principal Investigator) | Massachusetts General Hospital | 617-643-9314 | tbaggett@mgh.harvard.edu |
| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
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| Day 7 |
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| Day 10 |
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| Day 12 |
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| Day 14 |
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| Day 17 |
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| Day 21 |
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| Day 24 |
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| Day 28 |
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| Day 35 |
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| Day 42 |
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| Day 49 |
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| Day 56 |
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| OG002 | Text Messaging (N=25) |
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 |
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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 |
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| OG002 | Text Messaging (N=25) |
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 |
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| OG002 | Text Messaging (N=25) |
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 |
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| OG002 | Text Messaging (N=25) |
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 |
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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
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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
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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 |
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