Innovations to Prevent Relapse Among Low-income African American Smokers

Smoking Cessation Clinical Trial

Official title:

Innovations to Prevent Relapse Among Low-income African American Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03982576
• Other study ID #: CASE5Y18
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: November 2021
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Recurrence
• Smoking Cessation

Intervention

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

Locations

Country	Name	City	State
United States	Case Western Reserve University, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Time to smoking relapse (TTR)	Time to smoking relapse (TTR) over a 3 month period	up to 3 months from start of treatment
Secondary	Smoking urges	Measured through Weekly the Questionnaire of Smoking Urges (QSU) with scores ranging from 10-70, higher scores indicating greater urges.	20 minutes, 6-weeks follow-up, and 3-months from end of treatment.
Secondary	Percent of participants adhering to nicotine replacement therapy (NRT)	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.	20 minutes, 6-weeks follow-up, and 3-months from end of treatment.