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

June 15, 2017 updated by: Travis Paul Baggett, Massachusetts General Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Health Care for the Homeless Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control (N=25)
  • Transdermal nicotine patch
  • In-person smoking cessation counseling
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
Other Names:
  • Nicotine
Behavioral: In-person smoking cessation counseling
- One-on-one 15-minute counseling sessions once per week for 8 weeks
Experimental: Financial rewards (N=25)
  • Transdermal nicotine patch
  • In-person smoking cessation counseling
  • Contingent financial rewards for smoking abstinence
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
Other Names:
  • Nicotine
Behavioral: In-person smoking cessation counseling
- One-on-one 15-minute counseling sessions once per week for 8 weeks
Behavioral: Contingent financial rewards for smoking abstinence
- Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm
Other Names:
  • Contingency management
Experimental: Text messaging (N=25)
  • Transdermal nicotine patch
  • In-person smoking cessation counseling
  • Text messages to support smoking abstinence
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
Other Names:
  • Nicotine
Behavioral: In-person smoking cessation counseling
- One-on-one 15-minute counseling sessions once per week for 8 weeks
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
8 weeks
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.
8 weeks
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.
Once per week for 8 weeks
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.
4 weeks and 8 weeks
Study Visit Attendance
Time Frame: 8 weeks
Percentage of 14 assessment visits attended.
8 weeks
Counseling Visit Attendance
Time Frame: 8 weeks
Percentage of 8 counseling visits attended.
8 weeks
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.
8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recruitment Time
Time Frame: Until target number of participants is reached; anticipate ~6 months
Total time to recruit, enroll, and randomize 75 study participants.
Until target number of participants is reached; anticipate ~6 months
Mobile Phone Retention
Time Frame: 8 weeks
Percentage of participants who still have their mobile phone at the end of the study.
8 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Travis P Baggett, MD, MPH, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015P001300
  • K23DA034008 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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