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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control (N=25)

* Transdermal nicotine patch
* In-person smoking cessation counseling

Group Type ACTIVE_COMPARATOR

Transdermal nicotine patch

Intervention Type 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

In-person smoking cessation counseling

Intervention Type BEHAVIORAL

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

Financial rewards (N=25)

* Transdermal nicotine patch
* In-person smoking cessation counseling
* Contingent financial rewards for smoking abstinence

Group Type EXPERIMENTAL

Transdermal nicotine patch

Intervention Type 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

In-person smoking cessation counseling

Intervention Type BEHAVIORAL

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

Contingent financial rewards for smoking abstinence

Intervention Type BEHAVIORAL

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

Text messaging (N=25)

* Transdermal nicotine patch
* In-person smoking cessation counseling
* Text messages to support smoking abstinence

Group Type EXPERIMENTAL

Transdermal nicotine patch

Intervention Type 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

In-person smoking cessation counseling

Intervention Type BEHAVIORAL

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

Text messages to support smoking abstinence

Intervention Type 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

Interventions

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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

Intervention Type DRUG

In-person smoking cessation counseling

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

Intervention Type BEHAVIORAL

Contingent financial rewards for smoking abstinence

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

Intervention Type 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

Intervention Type BEHAVIORAL

Other Intervention Names

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Nicotine Contingency management

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No