NCT03982576

Innovations to Prevent Relapse Among Low-income African American Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
OTHER	Nicotine replacement therapy (NRT)	4 weeks of Transdermal nicotine patches or nicotine gum
BEHAVIORAL	CS-CBT intervention	4 group sessions of a novel culturally specific, CBT-based intervention over 2 weeks
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).
BEHAVIORAL	Relapse prevention program	4 group sessions of a standard relapse prevention program, publicly available at smokefree.gov
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

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-10-31
• Completion: 2019-10-31
• First posted: 2019-06-11
• Last updated: 2021-11-04

Locations

1 site across 1 country: United States