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Completed

NCT Number: NCT03982576

Innovations to Prevent Relapse Among Low-income African American Smokers

The purpose of this research is to study a relapse prevention program for adult former smokers in Northeast Ohio. The study will also look at how different people respond to the program. Participants asked to take part in this study because they contacted the team for help remaining tobacco-free or otherwise expressed interest in the program. The study includes completing surveys and receiving text messages to help stay tobacco free.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

About this study

The main objective of this study is to conduct a pilot study to assess the feasibility, acceptability, and initial efficacy/clinical significance of a tobacco relapse prevention intervention designed for low-income African Americans.

In this study, the team will estimate effect sizes for a culturally specific (CS) relapse prevention intervention compared to standard relapse prevention in a sample of low-income African American smokers and examine predictors of time to smoking relapse.

In a community-based clinical trial, adults who recently quit smoking (N=100) will be randomly assigned to one of two experimental conditions: (1) CS Relapse Prevention or (2) Standard Relapse Prevention. The primary outcome variables collected will include biochemically verified point prevalence abstinence (ppa) at 6-weeks and time to smoking relapse (TTR) over 3-months. This study will test daily hassles, cessation self-efficacy, coping strategies, and adherence to NRT as individual difference factors that may affect response to CS relapse prevention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult smokers recruited from the community by study community navigator and flyers
  • Self-identify as African American
  • Report no tobacco smoking within the past 3-90 days and have a carbon monoxide (CO) reading of ≤ 3 ppm
  • Have access to SMS texting
  • Meet federal definitions of low-income

Exclusion criteria

  • Study team will offer to enroll ineligible smokers in the publicly available smokefreeTXT (if applicable) or refer them to the Ohio state quitline

Treatment and study plan

Nicotine replacement therapy (NRT)

Other

4 weeks of Transdermal nicotine patches or nicotine gum

CS-CBT intervention

Behavioral

4 group sessions of a novel culturally specific, CBT-based intervention over 2 weeks

Path2Quit

Behavioral

Path2Quit is a newly developed video-text program, which delivers 6 weeks of CS video messages (1-2 times/day) and provides 24/7 access to messages pulled from 3 keywords (HELP1, JONES, SLIP).

Relapse prevention program

Behavioral

4 group sessions of a standard relapse prevention program, publicly available at smokefree.gov

SmokefreeTXT

Behavioral

NCI's 6-week fully automated text-based cessation program that is free to U.S. subscribers, and is available on smokefree.gov. Users can text one of 3 keywords (MOOD, CRAVE, or SLIP) to receive a relevant message from the system 24/7

Primary outcomes

  1. Biochemically verified point prevalence abstinence (ppa)

    Time frame: at 6-weeks from start of treatment

    Biochemically verified point prevalence abstinence (ppa) confirmed by breath carbon monoxide and saliva cotinine will confirm self-reported cessation at each follow-up.

  2. Time to smoking relapse (TTR)

    Time frame: up to 3 months from start of treatment

    Time to smoking relapse (TTR) over a 3 month period

Secondary outcomes

  1. Smoking urges

    Time frame: 20 minutes, 6-weeks follow-up, and 3-months from end of treatment.

    Measured through Weekly the Questionnaire of Smoking Urges (QSU) with scores ranging from 10-70, higher scores indicating greater urges.

  2. Percent of participants adhering to nicotine replacement therapy (NRT)

    Time frame: 20 minutes, 6-weeks follow-up, and 3-months from end of treatment.

    Timeline follow-back (TLFB) instrument used to record daily use of NRT per day. The TLFB is a calendar that assesses daily smoking and NRT use. Based on participants' reconstruction of their smoking history, abstinence variables will be determined. For instance, if there has been no smoking in the 7 days preceding the assessment, the criterion for 7-day point prevalence abstinence (ppa) will be met.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 11, 2019
Registry last updated
Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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