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Innovations to Prevent Relapse Among Low-income African American Smokers

NCT ID: NCT03982576

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2-arm semi-pragmatic randomized design among recently quit smokers (N = 100). Random assignment (1:1 ratio, stratified by building and sex).
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CS Relapse Prevention

Participants will receive 4 group sessions of a novel culturally specific, CBT-based intervention. They will also receive Path2Quit, 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). Notably, CS relapse prevention will incorporate surface and deep structure elements,17 including race-matched interventionists, religion/spirituality, discussion of race-related stress, traditional values (e.g., collectivism), culturally specific recipes, etc.

All participants will receive 4 weeks of nicotine replacement therapy (NRT; transdermal nicotine patches or nicotine gum).

Group Type EXPERIMENTAL

Nicotine replacement therapy (NRT)

Intervention Type OTHER

4 weeks of Transdermal nicotine patches or nicotine gum

CS-CBT intervention

Intervention Type BEHAVIORAL

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

Path2Quit

Intervention Type 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).

Standard Relapse Prevention

Participants will receive 4 group sessions of a standard relapse prevention program, publicly available at smokefree.gov. Participants will also receive SmokefreeTXT, the 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.

All participants will receive 4 weeks of nicotine replacement therapy (NRT; transdermal nicotine patches or nicotine gum).

Group Type ACTIVE_COMPARATOR

Nicotine replacement therapy (NRT)

Intervention Type OTHER

4 weeks of Transdermal nicotine patches or nicotine gum

Relapse prevention program

Intervention Type BEHAVIORAL

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

SmokefreeTXT

Intervention Type 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

Interventions

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Nicotine replacement therapy (NRT)

4 weeks of Transdermal nicotine patches or nicotine gum

Intervention Type OTHER

CS-CBT intervention

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

Intervention Type BEHAVIORAL

Path2Quit

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).

Intervention Type BEHAVIORAL

Relapse prevention program

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

Intervention Type BEHAVIORAL

SmokefreeTXT

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Monica Webb Hooper, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University, Case Comprehensive Cancer Center

Locations

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Case Western Reserve University, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CASE5Y18

Identifier Type: -

Identifier Source: org_study_id