Innovations to Prevent Relapse Among Low-income African American Smokers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Biochemically verified point prevalence abstinence (ppa)
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Biochemically verified point prevalence abstinence (ppa)
Time Frame: at 6-weeks from start of treatment
Biochemically verified point prevalence abstinence (ppa) confirmed by breath carbon monoxide and saliva cotinine will confirm self-reported cessation at each follow-up.
Time to smoking relapse (TTR)
Time Frame: up to 3 months from start of treatment
Time to smoking relapse (TTR) over a 3 month period
Secondary Outcomes
- 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.)