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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
83
* ≥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
\- One-on-one 15-minute counseling sessions once per week for 8 weeks
\- Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide \<8ppm
\- 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
Boston Health Care for the Homeless Program
Boston, Massachusetts, United States
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
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
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
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
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
Study Visit Attendance
Percentage of 14 assessment visits attended.
Time frame: 8 weeks
Counseling Visit Attendance
Percentage of 8 counseling visits attended.
Time frame: 8 weeks
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
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