Innovations to Prevent Relapse Among Low-income African American Smokers

NCT03982576 | Completed DMC

• 1 other identifier: CASE5Y18
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• Biochemically verified point prevalence abstinence (ppa)

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

  at 6-weeks from start of treatment

• Time to smoking relapse (TTR)

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

  up to 3 months from start of treatment

Secondary Outcomes (2)

• Smoking urges

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

• Percent of participants adhering to nicotine replacement therapy (NRT)

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

Study Arms (2)

CS Relapse Prevention

EXPERIMENTAL

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).

Other: Nicotine replacement therapy (NRT); Behavioral: CS-CBT intervention; Behavioral: Path2Quit

Standard Relapse Prevention

ACTIVE COMPARATOR

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).

Other: Nicotine replacement therapy (NRT); Behavioral: Relapse prevention program; Behavioral: SmokefreeTXT

Interventions

Nicotine replacement therapy (NRT) OTHER

4 weeks of Transdermal nicotine patches or nicotine gum

CS Relapse Prevention; Standard Relapse Prevention

CS-CBT intervention BEHAVIORAL

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

CS Relapse Prevention

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).

CS Relapse Prevention

Relapse prevention program BEHAVIORAL

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

Standard Relapse Prevention

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

Standard Relapse Prevention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Case Western Reserve University, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Monica Webb Hooper, PhD

  Case Western Reserve University, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 11, 2019
• Study Start: January 1, 2019
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: November 4, 2021

Record last verified: 2021-11

Locations

US (1)