Tobacco and Socioeconomic Disadvantage

Tobacco Smoking Clinical Trial

Official title:

Addressing Tobacco Use Among Those At Socioeconomic Disadvantage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620708
• Other study ID #: Pro20170000679
• Status: Completed
• Phase: Phase 4
• Start date: May 30, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: November 2019
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tobacco Smoking

Intervention

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.

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.

Behavioral:
• Referral Only
Participants are provided with a written referral for tobacco dependence treatment.

Locations

Country	Name	City	State
United States	Division of Addiction Psychiatry	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Self-reported Cigarettes Per Day	Self-reported cigarettes smoked per day; abstinence to be biochemically verified with carbon monoxide < 5ppm	30 days
Secondary	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
Secondary	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