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

The QUIT Smoking Study: A Pilot Randomized Controlled Trial of Financial Incentives, Text Messaging, and Usual Care to Help Homeless Smokers Quit Smoking

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 Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Drug: Transdermal nicotine patch; Behavioral: In-person smoking cessation counseling; Behavioral: Contingent financial rewards for smoking abstinence; Behavioral: Text messages to support smoking abstinence

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Health Care for the Homeless Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control (N=25); Transdermal nicotine patch; In-person smoking cessation counseling	Drug: 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; Other Names: Nicotine; Behavioral: In-person smoking cessation counseling; - One-on-one 15-minute counseling sessions once per week for 8 weeks
Experimental: Financial rewards (N=25); Transdermal nicotine patch; In-person smoking cessation counseling; Contingent financial rewards for smoking abstinence	Drug: 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; Other Names: Nicotine; Behavioral: In-person smoking cessation counseling; - One-on-one 15-minute counseling sessions once per week for 8 weeks; Behavioral: Contingent financial rewards for smoking abstinence; - Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm; Other Names: Contingency management
Experimental: Text messaging (N=25); Transdermal nicotine patch; In-person smoking cessation counseling; Text messages to support smoking abstinence	Drug: 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; Other Names: Nicotine; Behavioral: In-person smoking cessation counseling; - One-on-one 15-minute counseling sessions once per week for 8 weeks; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Travis P Baggett, MD, MPH, Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: September 29, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Actual): July 14, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2015P001300; K23DA034008 (U.S. NIH Grant/Contract)