Tobacco and Socioeconomic Disadvantage

NCT ID: NCT03620708

Last Updated: 2019-11-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-30

Study Completion Date

2018-10-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Tobacco Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial in which participants are randomized to one of three groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The individual conducting the outcomes assessment is blind to study condition.

Study Groups

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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

Group Type EXPERIMENTAL

Motivational Interviewing

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Nicotine Replacement Therapy Sampling

Intervention Type DRUG

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.

Referral Only

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

Group Type OTHER

Referral Only

Intervention Type BEHAVIORAL

Participants are provided with a written referral for tobacco dependence treatment.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type DRUG

Referral Only

Participants are provided with a written referral for tobacco dependence treatment.

Intervention Type BEHAVIORAL

Other Intervention Names

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Nicotine Replacement Therapy Referral

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Marc L. Steinberg, Ph.D.

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marc L Steinberg, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rutgers Robert Wood Johnson Medical School

Locations

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Division of Addiction Psychiatry

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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Pro20170000679

Identifier Type: -

Identifier Source: org_study_id

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