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Completed

NCT Number: NCT02565381

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

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.

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Key information

Conditions

Smoking Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Health Care for the Homeless Program

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transdermal Nicotine Patch

Drug
  • ≥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

In-person smoking cessation counseling

Behavioral
  • One-on-one 15-minute counseling sessions once per week for 8 weeks

Contingent financial rewards for smoking abstinence

Behavioral
  • Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm

Other names: Contingency management

Text messages to support smoking abstinence

Behavioral
  • 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

  1. Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks

    Time frame: Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study period

    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)

Secondary outcomes

  1. Percentage of Visits Abstinent of Smoking

    Time frame: 8 weeks

    Percentage of 14 assessment visits at which a participant is abstinent of smoking, defined as an exhaled carbon monoxide level <8ppm.

  2. Smoking Abstinence at End of Study

    Time frame: 8 weeks

    Point-prevalence smoking abstinence, defined as an exhaled carbon monoxide level <8ppm, at the 14th (final) study visit.

  3. Change in Cigarette Consumption

    Time frame: Once per week for 8 weeks

    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.

  4. Change in Behavioral Health

    Time frame: 4 weeks and 8 weeks

    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.

  5. Study Visit Attendance

    Time frame: 8 weeks

    Percentage of 14 assessment visits attended.

  6. Counseling Visit Attendance

    Time frame: 8 weeks

    Percentage of 8 counseling visits attended.

  7. Nicotine Patch Use

    Time frame: 8 weeks

    Days of nicotine replacement therapy use in past week, repeatedly measured at the 8 assessment visits occurring on Fridays.

Other outcomes

  1. Recruitment Time

    Time frame: Until target number of participants is reached; anticipate ~6 months

    Total time to recruit, enroll, and randomize 75 study participants.

  2. Mobile Phone Retention

    Time frame: 8 weeks

    Percentage of participants who still have their mobile phone at the end of the study.

  3. Use of Text Messaging Program

    Time frame: 8 weeks

    Text messaging group only: number who enrolled in SmokefreeTXT, number who replied to query texts sent by SmokefreeTXT.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: QUIT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 1, 2015
Registry last updated
Jul 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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