Tobacco and Socioeconomic Disadvantage

Addressing Tobacco Use Among Those At Socioeconomic Disadvantage

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

Study Overview

• Status: Completed
• Conditions: Tobacco Smoking
• Intervention / Treatment: Behavioral: Motivational Interviewing; Drug: Nicotine Replacement Therapy Sampling; Behavioral: Referral Only

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Division of Addiction Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motivational Interviewing; 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	Behavioral: Motivational Interviewing; Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.
Active Comparator: Nicotine Replacement Therapy Sampling; 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.	Drug: Nicotine Replacement Therapy Sampling; Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.; Other Names: Nicotine Replacement Therapy
Other: Referral Only; Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.	Behavioral: Referral Only; Participants are provided with a written referral for tobacco dependence treatment.; Other Names: Referral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire'	A self-described "serious" attempt to quit smoking cigarettes since the initial study appointment, measured by the "Quitting Preparation and Actions Questionnaire."	30 days
Self-reported Treatment Seeking Measured Via the 'Quitting Preparation and Actions Questionnaire'	Self-reported contact with one of two treatment referrals provided at intervention since the time of the initial study appointment	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Cigarettes Per Day	Self-reported cigarettes smoked per day; abstinence to be biochemically verified with carbon monoxide < 5ppm	30 days
Importance, Confidence, & Readiness Questionnaire	Motivation and Self-efficacy for quitting smoking measured via Importance, Confidence, & Readiness Questionnaire" (rated on a 0 to 10 scale with higher numbers indicating greater importance, confidence, or readiness to quit)	30 days
Readiness to Quit Ladder	"Readiness to Quit Ladder" (with 10 non-numbered choices, ranging from 0 to 10 reflecting varying degrees of readiness to quit smoking; higher numbers reflect greater readiness to quit smoking)	30 days

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Marc L Steinberg, Ph.D., Rutgers Robert Wood Johnson Medical School

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2018
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): November 15, 2019
• Last Update Submitted That Met QC Criteria: November 13, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: smoking; tobacco; cigarette
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: Pro20170000679

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes