Clinical trial NCT03982576: Innovations to Prevent Relapse Among Low-income African American Smokers
Official title: Innovations to Prevent Relapse Among Low-income African American Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm semi-pragmatic randomized design among recently quit smokers (N = 100). Random assignment (1:1 ratio, stratified by building and sex).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Biochemically verified point prevalence abstinence (ppa)
timeFrame: at 6-weeks from start of treatment
measure: Time to smoking relapse (TTR)
timeFrame: up to 3 months from start of treatment
Secondary outcomes:
measure: Smoking urges
timeFrame: 20 minutes, 6-weeks follow-up, and 3-months from end of treatment.
measure: Percent of participants adhering to nicotine replacement therapy (NRT)
timeFrame: 20 minutes, 6-weeks follow-up, and 3-months from end of treatment.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University, Case Comprehensive Cancer Center
name: Monica Webb Hooper, PhD
role: PRINCIPAL_INVESTIGATOR
References: