Overview

This trial is active, not recruiting.

Condition smoking
Treatments transdermal nicotine patch, in-person smoking cessation counseling, contingent financial rewards for smoking abstinence, text messages to support smoking abstinence
Sponsor Massachusetts General Hospital
Collaborator National Institute on Drug Abuse (NIDA)
Start date October 2015
End date June 2016
Trial size 83 participants
Trial identifier NCT02565381, 2015P001300, K23DA034008

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Transdermal nicotine patch In-person smoking cessation counseling
transdermal nicotine patch Nicotine
≥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
in-person smoking cessation counseling
- One-on-one 15-minute counseling sessions once per week for 8 weeks
(Experimental)
Transdermal nicotine patch In-person smoking cessation counseling Contingent financial rewards for smoking abstinence
transdermal nicotine patch Nicotine
≥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
in-person smoking cessation counseling
- One-on-one 15-minute counseling sessions once per week for 8 weeks
contingent financial rewards for smoking abstinence Contingency management
- Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm
(Experimental)
Transdermal nicotine patch In-person smoking cessation counseling Text messages to support smoking abstinence
transdermal nicotine patch Nicotine
≥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
in-person smoking cessation counseling
- One-on-one 15-minute counseling sessions once per week for 8 weeks
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

Primary Outcomes

Measure
Repeated measure of biochemically-verified smoking abstinence
time frame: 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
time frame: 8 weeks
Smoking abstinence at end of study
time frame: 8 weeks
Change in cigarette consumption
time frame: Once per week for 8 weeks
Change in behavioral health
time frame: 4 weeks and 8 weeks
Study visit attendance
time frame: 8 weeks
Counseling visit attendance
time frame: 8 weeks
Nicotine patch use
time frame: 8 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Travis P Baggett, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.