N/A
Completed N=75
A Pilot Randomized Controlled Trial of Financial Incentives, Text Messaging, and Usual Care for Homeless Smokers
Source: ClinicalTrials.gov NCT02565381 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks — 3; 10; 3; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks |
3; 10; 3; 0; 9; 1 | — |
| SECONDARY Percentage of Visits Abstinent of Smoking |
12.6; 51.1; 11.7 | — |
| SECONDARY Smoking Abstinence at End of Study |
2; 12; 4 | — |
| SECONDARY Change in Cigarette Consumption |
-5.3; -8.5; -6.0; -6.7; -8.6; -7.5 | — |
| SECONDARY Change in Behavioral Health |
-0.02; -0.04; -0.09; -0.01; 0.01; -0.04 | — |
| SECONDARY Study Visit Attendance |
65.4; 71.1; 65.7 | — |
| SECONDARY Counseling Visit Attendance |
17.0; 10.5; 17.0 | — |
| SECONDARY Nicotine Patch Use |
3.7; 4.1; 4.5; 4.9; 4.5; 4.5 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02565381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.