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

Smoking Clinical Trial

— QUIT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565381
• Other study ID #: 2015P001300
• Secondary ID: K23DA034008
• Status: Completed
• Phase: N/A
• First received: September 29, 2015
• Last updated: March 21, 2017
• Start date: October 2015
• Est. completion date: August 2016

Study information

• Verified date: March 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking

Intervention

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

Behavioral:
• In-person smoking cessation counseling
- One-on-one 15-minute counseling sessions once per week for 8 weeks
• Contingent financial rewards for smoking abstinence
- Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm
• 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

Locations

Country	Name	City	State
United States	Boston Health Care for the Homeless Program	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recruitment time	Total time to recruit, enroll, and randomize 75 study participants.	Until target number of participants is reached; anticipate ~6 months
Other	Mobile phone retention	Median retention time of study-supplied mobile phones and percentage of participants who still have their mobile phone at the end of the study.	8 weeks
Other	Use of text messaging program	Text messaging group only: Enrollment in SmokefreeTXT, duration of program enrollment, use of on-demand features, and replies to query texts sent by program.	8 weeks
Primary	Repeated measure of biochemically-verified smoking abstinence	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	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
Secondary	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
Secondary	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
Secondary	Change in behavioral health	Changes in past-month drug use severity, past-month alcohol use severity, and past-month psychiatric severity, each assessed with the Addiction Severity Index - 5th Edition, at the 10th and 14th study visits relative to baseline.	4 weeks and 8 weeks
Secondary	Study visit attendance	Percentage of 14 assessment visits attended.	8 weeks
Secondary	Counseling visit attendance	Percentage of 8 counseling visits attended.	8 weeks
Secondary	Nicotine patch use	Days of nicotine replacement therapy use in past week, repeatedly measured at the 8 assessment visits occurring on Fridays.	8 weeks