A Pilot Randomized Controlled Trial of Financial Incentives, Text Messaging, and Usual Care for Homeless Smokers

Not Applicable

Completed

Conditions: Smoking

Interventions: Drug: Transdermal nicotine patch
Behavioral: In-person smoking cessation counseling
Behavioral: Text messages to support smoking abstinence
Behavioral: Contingent financial rewards for smoking abstinence

Registration Number: NCT02565381

Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 83

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Financial rewards (N=25)	Transdermal nicotine patch	* Transdermal nicotine patch * In-person smoking cessation counseling * Contingent financial rewards for smoking abstinence
Text messaging (N=25)	In-person smoking cessation counseling	* Transdermal nicotine patch * In-person smoking cessation counseling * Text messages to support smoking abstinence
Text messaging (N=25)	Transdermal nicotine patch	* Transdermal nicotine patch * In-person smoking cessation counseling * Text messages to support smoking abstinence
Control (N=25)	In-person smoking cessation counseling	* Transdermal nicotine patch * In-person smoking cessation counseling
Financial rewards (N=25)	In-person smoking cessation counseling	* Transdermal nicotine patch * In-person smoking cessation counseling * Contingent financial rewards for smoking abstinence
Text messaging (N=25)	Text messages to support smoking abstinence	* Transdermal nicotine patch * In-person smoking cessation counseling * Text messages to support smoking abstinence
Control (N=25)	Transdermal nicotine patch	* Transdermal nicotine patch * In-person smoking cessation counseling
Financial rewards (N=25)	Contingent financial rewards for smoking abstinence	* Transdermal nicotine patch * In-person smoking cessation counseling * Contingent financial rewards for smoking abstinence

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Counseling Visit Attendance	8 weeks	Percentage of 8 counseling visits attended.
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.
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.
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.
Study Visit Attendance	8 weeks	Percentage of 14 assessment 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.
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.