Phase 4
N=58
Tobacco and Socioeconomic Disadvantage
Tobacco Smoking
Bottom Line
View on ClinicalTrials.gov: NCT03620708 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire' — 5; 10; 6 Participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Motivational Interviewing (Behavioral); Nicotine Replacement Therapy Sampling (Drug); Referral Only (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire' |
5; 10; 6 | <0.05 sig |
| PRIMARY Self-reported Treatment Seeking Measured Via the 'Quitting Preparation and Actions Questionnaire' |
0; 1; 3 | .113 |
| SECONDARY Self-reported Cigarettes Per Day |
13.0; 7.6; 10.3 | .032 sig |
| SECONDARY Importance, Confidence, & Readiness Questionnaire |
4.8; 5.5; 6.5; 7.6; 7.3; 8.1 | .227 |
| SECONDARY Readiness to Quit Ladder |
5.7; 6.6; 6.4 | .188 |
Summary
Randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers.
Eligibility Criteria
Inclusion Criteria
- Participants must be between the age of 19 and 65
- Participants must self-report being a daily smoker and provide biochemical verification of smoking status (expired breath carbon monoxide reading >5)
- Participants must be at socioeconomic disadvantage, defined as receiving services at a New Brunswick, New Jersey based social services agency (i.e., living in New Brunswick Housing Authority-run public housing units or requesting social services from the community social service agency, "Elijah's Promise")
- Participants must be able to speak and read English.
Exclusion Criteria
- Participants may not be taking FDA approved smoking cessation or anti-psychotic medications
- Participants may not reported medical issues of potential concern to nicotine replacement users (e.g., unstable angina pectoris, myocardial infarction, or significant cardiac arrythmia (including atrial fibrillation) in the past 30 days)
- Participants may not report pending legal issues with potential to result in incarceration.
- Participants may not be pregnant or nursing, planning on becoming pregnant in the next two months, and must be using effective birth control.
Data sourced from ClinicalTrials.gov (NCT03620708). 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.