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

What Was Tested

In this not phased trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

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.

It had three arms (groups): Control (N=25) (active comparator), Financial rewards (N=25) (experimental) and Text messaging (N=25) (experimental).

* Transdermal nicotine patch * In-person smoking cessation counseling.

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

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

The registry classes the interventions as behavioral and drug.

Who Took Part

Enrollment: 83 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: heart attack or chest pain within the past 2 weeks; inability to read a sentence written at a flesch-kincaid grade level of 4.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Therapeutic nicotine (patch, non-peptide) study did not mask who received what.

It started in 2015-10 with completion listed for 2016-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 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).

It also tracked 7 secondary outcomes, for example Percentage of Visits Abstinent of Smoking, Smoking Abstinence at End of Study, Change in Cigarette Consumption, Change in Behavioral Health, Study Visit Attendance and Counseling Visit Attendance.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 83 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.