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Tobacco and Socioeconomic Disadvantage

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ClinicalTrials.gov Identifier: NCT03620708
Recruitment Status : Completed
First Posted : August 8, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Marc L. Steinberg, Ph.D., Rutgers, The State University of New Jersey

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

Condition or disease Intervention/treatment Phase
Tobacco Smoking Behavioral: Motivational Interviewing Drug: Nicotine Replacement Therapy Sampling Behavioral: Referral Only Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial in which participants are randomized to one of three groups.
Masking: Single (Outcomes Assessor)
Masking Description: The individual conducting the outcomes assessment is blind to study condition.
Primary Purpose: Treatment
Official Title: Addressing Tobacco Use Among Those At Socioeconomic Disadvantage
Actual Study Start Date : May 30, 2018
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

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 Name: Nicotine Replacement Therapy

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 Name: Referral




Primary Outcome Measures :
  1. Self-reported serious Quit Attempt measured via the 'Quitting Preparation and Actions Questionnaire' [ Time Frame: 30 days ]
    A self-described "serious" attempt to quit smoking cigarettes since the initial study appointment.

  2. Self-reported Treatment Seeking measured via the 'Quitting Preparation and Actions Questionnaire' [ Time Frame: 30 days ]
    Self-reported contact with one of two treatment referrals provided at intervention since the time of the initial study appointment


Secondary Outcome Measures :
  1. Self-reported Cigarettes per day [ Time Frame: 30 days ]
    Self-reported cigarettes smoked per day; abstinence to be biochemically verified with carbon monoxide < 5ppm

  2. Importance, Confidence, & Readiness Questionnaire [ Time Frame: 30 days ]
    Motivation and Self-efficacy for quitting smoking measured via Importance, Confidence, & Readiness Questionnaire" (rated on a 0 to 10 scale)

  3. Readiness to Quit Ladder [ Time Frame: 30 days ]
    "Readiness to Quit Ladder" (with 10 non-numbered choices reflecting varying degrees of readiness to quit smoking)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620708


Locations
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United States, New Jersey
Division of Addiction Psychiatry
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Marc L Steinberg, Ph.D. Rutgers Robert Wood Johnson Medical School

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Responsible Party: Marc L. Steinberg, Ph.D., Associate Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03620708     History of Changes
Other Study ID Numbers: Pro20170000679
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Marc L. Steinberg, Ph.D., Rutgers, The State University of New Jersey:
tobacco
smoking
cigarette

Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action