Smoking Cessation
Conditions
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.
Interventions
OTHERNicotine replacement therapy (NRT)
4 weeks of Transdermal nicotine patches or nicotine gum
BEHAVIORALCS-CBT intervention
4 group sessions of a novel culturally specific, CBT-based intervention over 2 weeks
BEHAVIORALPath2Quit
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).
BEHAVIORALRelapse prevention program
4 group sessions of a standard relapse prevention program, publicly available at smokefree.gov
BEHAVIORALSmokefreeTXT
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
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically verified point prevalence abstinence (ppa) | 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) | up to 3 months from start of treatment | Time to smoking relapse (TTR) over a 3 month period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Smoking urges | 20 minutes, 6-weeks follow-up, and 3-months from end of treatment. | Measured through Weekly the Questionnaire of Smoking Urges (QSU) with scores ranging from 10-70, higher scores indicating greater urges. |
| Percent of participants adhering to nicotine replacement therapy (NRT) | 20 minutes, 6-weeks follow-up, and 3-months from end of treatment. | 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. |
Countries
United States
Outcome results
None listed