An interventional study of Nicotine replacement therapy (NRT) and CS-CBT intervention in Smoking Cessation, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-04.
Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Prevention
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.
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.
4,278 studies on the registry are indexed under Recurrence; 990 are open to participants now.
This study's enrollment of 18 is below the median of 50 across 3,373 interventional studies indexed under Recurrence.
Browse Recurrence studies →Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.
Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.
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Exclusion Criteria:
Participants will receive 4 group sessions of a novel culturally specific, CBT-based intervention. They will also receive Path2Quit, 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). Notably, CS relapse prevention will incorporate surface and deep structure elements,17 including race-matched interventionists, religion/spirituality, discussion of race-related stress, traditional values (e.g., collectivism), culturally specific recipes, etc. All participants will receive 4 weeks of nicotine replacement therapy (NRT; transdermal nicotine patches or nicotine gum).
Other: Nicotine replacement therapy (NRT) · Behavioral: CS-CBT intervention · Behavioral: Path2Quit
Participants will receive 4 group sessions of a standard relapse prevention program, publicly available at smokefree.gov. Participants will also receive SmokefreeTXT, the 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. All participants will receive 4 weeks of nicotine replacement therapy (NRT; transdermal nicotine patches or nicotine gum).
Other: Nicotine replacement therapy (NRT) · Behavioral: Relapse prevention program · Behavioral: SmokefreeTXT
4 weeks of Transdermal nicotine patches or nicotine gum
4 group sessions of a novel culturally specific, CBT-based intervention over 2 weeks
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).
4 group sessions of a standard relapse prevention program, publicly available at smokefree.gov
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
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.
Time frame: at 6-weeks from start of treatment
Time to smoking relapse (TTR)
Time to smoking relapse (TTR) over a 3 month period
Time frame: up to 3 months from start of treatment
Smoking urges
Measured through Weekly the Questionnaire of Smoking Urges (QSU) with scores ranging from 10-70, higher scores indicating greater urges.
Time frame: 20 minutes, 6-weeks follow-up, and 3-months from end of treatment.
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.
Time frame: 20 minutes, 6-weeks follow-up, and 3-months from end of treatment.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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