- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03982576
Innovations to Prevent Relapse Among Low-income African American Smokers
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ohio
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Cleveland, Ohio, United States, 44106
- Case Western Reserve University, Case Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CS Relapse Prevention
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). |
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).
|
Active Comparator: Standard Relapse Prevention
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). |
4 weeks of Transdermal nicotine patches or nicotine gum
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemically verified point prevalence abstinence (ppa)
Time Frame: at 6-weeks from start of treatment
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Biochemically verified point prevalence abstinence (ppa) confirmed by breath carbon monoxide and saliva cotinine will confirm self-reported cessation at each follow-up.
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at 6-weeks from start of treatment
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Time to smoking relapse (TTR)
Time Frame: up to 3 months from start of treatment
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Time to smoking relapse (TTR) over a 3 month period
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up to 3 months from start of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking urges
Time Frame: 20 minutes, 6-weeks follow-up, and 3-months from end of treatment.
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Measured through Weekly the Questionnaire of Smoking Urges (QSU) with scores ranging from 10-70, higher scores indicating greater urges.
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20 minutes, 6-weeks follow-up, and 3-months from end of treatment.
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Percent of participants adhering to nicotine replacement therapy (NRT)
Time Frame: 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.
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20 minutes, 6-weeks follow-up, and 3-months from end of treatment.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Monica Webb Hooper, PhD, Case Western Reserve University, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASE5Y18
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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