Clinical trial NCT02565381: A Pilot Randomized Controlled Trial of Financial Incentives, Text Messaging, and Usual Care for Homeless Smokers
Official title: The QUIT Smoking Study: A Pilot Randomized Controlled Trial of Financial Incentives, Text Messaging, and Usual Care to Help Homeless Smokers Quit Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2015-10-01
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks
timeFrame: Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study period
Secondary outcomes:
measure: Percentage of Visits Abstinent of Smoking
timeFrame: 8 weeks
measure: Smoking Abstinence at End of Study
timeFrame: 8 weeks
measure: Change in Cigarette Consumption
timeFrame: Once per week for 8 weeks
measure: Change in Behavioral Health
timeFrame: 4 weeks and 8 weeks
measure: Study Visit Attendance
timeFrame: 8 weeks
measure: Counseling Visit Attendance
timeFrame: 8 weeks
measure: Nicotine Patch Use
timeFrame: 8 weeks
Other outcomes:
measure: Recruitment Time
timeFrame: Until target number of participants is reached; anticipate ~6 months
measure: Mobile Phone Retention
timeFrame: 8 weeks
measure: Use of Text Messaging Program
timeFrame: 8 weeks
Locations:
city: Boston
country: United States
facility: Boston Health Care for the Homeless Program
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Travis P Baggett, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.