Clinical trial NCT03620708: Tobacco and Socioeconomic Disadvantage
Official title: Addressing Tobacco Use Among Those At Socioeconomic Disadvantage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tobacco Smoking
Keywords: tobacco
smoking
cigarette
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial in which participants are randomized to one of three groups.
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers.

Detailed description: The investigators propose a randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers. Participants will be randomly assigned to receive a) A brief motivational interviewing intervention, b) A nicotine replacement therapy sampling intervention, or c) A referral-only intervention.

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.

Primary outcomes:
measure: Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire'
timeFrame: 30 days
measure: Self-reported Treatment Seeking Measured Via the 'Quitting Preparation and Actions Questionnaire'
timeFrame: 30 days
Secondary outcomes:
measure: Self-reported Cigarettes Per Day
timeFrame: 30 days
measure: Importance, Confidence, & Readiness Questionnaire
timeFrame: 30 days
measure: Readiness to Quit Ladder
timeFrame: 30 days
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Division of Addiction Psychiatry
state: New Jersey
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: Marc L Steinberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: