Tobacco and Socioeconomic Disadvantage

Rutgers The State University of New Jersey

Status and phase: Completed; Phase 4

Conditions: Tobacco Smoking

Treatments: Behavioral: Motivational Interviewing; Drug: Nicotine Replacement Therapy Sampling; Behavioral: Referral Only

Study type: Interventional

Funder types: Other

Identifiers

NCT03620708

Pro20170000679

Details and patient eligibility

About

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

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 3 patient groups

Motivational Interviewing

Experimental group

Description:

35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line

Treatment:

Behavioral: Motivational Interviewing

Nicotine Replacement Therapy Sampling

Active Comparator group

Description:

Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.

Treatment:

Drug: Nicotine Replacement Therapy Sampling

Referral Only

Other group

Description:

Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.

Treatment:

Behavioral: Referral Only