Innovations to Prevent Relapse Among Low-income African American Smokers

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Smoking Cessation

Treatments: Behavioral: Path2Quit; Behavioral: CS-CBT intervention; Behavioral: Relapse prevention program; Behavioral: SmokefreeTXT; Other: Nicotine replacement therapy (NRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03982576

CASE5Y18

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

CS Relapse Prevention

Experimental group

Description:

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).

Treatment:

Behavioral: CS-CBT intervention

Other: Nicotine replacement therapy (NRT)

Behavioral: Path2Quit

Standard Relapse Prevention

Active Comparator group

Description:

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).

Treatment:

Behavioral: SmokefreeTXT

Other: Nicotine replacement therapy (NRT)

Behavioral: Relapse prevention program