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
2 other identifiers
interventional
83
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2015
CompletedFirst Posted
Study publicly available on registry
October 1, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
July 14, 2017
CompletedJuly 14, 2017
June 1, 2017
8 months
September 29, 2015
May 20, 2017
June 15, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Percentage of Visits Abstinent of Smoking
8 weeks
Smoking Abstinence at End of Study
8 weeks
Change in Cigarette Consumption
Once per week for 8 weeks
Change in Behavioral Health
4 weeks and 8 weeks
Study Visit Attendance
8 weeks
- +2 more secondary outcomes
Other Outcomes (3)
Recruitment Time
Until target number of participants is reached; anticipate ~6 months
Mobile Phone Retention
8 weeks
Use of Text Messaging Program
8 weeks
Study Arms (3)
Control (N=25)
ACTIVE COMPARATOR* Transdermal nicotine patch * In-person smoking cessation counseling
Financial rewards (N=25)
EXPERIMENTAL* Transdermal nicotine patch * In-person smoking cessation counseling * Contingent financial rewards for smoking abstinence
Text messaging (N=25)
EXPERIMENTAL* Transdermal nicotine patch * In-person smoking cessation counseling * Text messages to support smoking abstinence
Interventions
* ≥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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Health Care for the Homeless Program
Boston, Massachusetts, 02118, United States
Related Publications (3)
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.
PMID: 31165717DERIVEDBaggett 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.
PMID: 29631559DERIVEDBaggett 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.
PMID: 29059442DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Small sample size; short duration of follow-up; primary outcome based exclusively on exhaled carbon monoxide measurement.
Results Point of Contact
- Title
- Travis P. Baggett, MD, MPH (Principal Investigator)
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Travis P Baggett, MD, MPH
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
September 29, 2015
First Posted
October 1, 2015
Study Start
October 1, 2015
Primary Completion
June 1, 2016
Study Completion
August 1, 2016
Last Updated
July 14, 2017
Results First Posted
July 14, 2017
Record last verified: 2017-06