Tobacco and Socioeconomic Disadvantage

NCT03620708 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro20170000679
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tobacco Smoking

Keywords

tobacco; smoking; cigarette

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Self-reported Cigarettes Per Day

  30 days

• Importance, Confidence, & Readiness Questionnaire

  30 days

• Readiness to Quit Ladder

  30 days

Study Arms (3)

Motivational Interviewing

EXPERIMENTAL

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

Nicotine Replacement Therapy Sampling

ACTIVE COMPARATOR

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

Referral Only

OTHER

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

Behavioral: Referral Only

Interventions

Motivational Interviewing 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.

Motivational Interviewing

Nicotine Replacement Therapy Sampling 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.

Also known as: Nicotine Replacement Therapy

Nicotine Replacement Therapy Sampling

Referral Only BEHAVIORAL

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

Also known as: Referral

Referral Only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Division of Addiction Psychiatry

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Tobacco Smoking; Smoking

Interventions

Motivational Interviewing; Nicotine Replacement Therapy; Referral and Consultation

Condition Hierarchy (Ancestors)

Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Drug Therapy; Therapeutics; Professional Practice; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Marc L. Steinberg, Ph.D.
• Organization: Rutgers Robert Wood Johnson Medical School

marc.steinberg@rutgers.edu

732-235-4341

Study Officials

• Marc L Steinberg, Ph.D.

  Rutgers Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The individual conducting the outcomes assessment is blind to study condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized clinical trial in which participants are randomized to one of three groups.

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: August 8, 2018
• Study Start: May 30, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 15, 2019
• Results First Posted: November 15, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)