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Take a Break + NRT for Smoking Cessation (TABR Trial)

N/A
Recruiting
Led By Rajani Sadasivam, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly from initial training to end of referral period year 1 to year 4 longitudinally
Awards & highlights

TABR Trial Summary

This trial aims to improve access to tobacco control services to help reduce smoking in rural areas - even for those not yet ready to quit. #tobaccocontrol #smokefree

Who is the study for?
This trial is for current smokers over 18 years old who speak English, are not ready to quit smoking but can read texts and have a text-enabled phone. It's not for prisoners, those unwilling to consent, actively quitting or planning to quit within a month, or with contraindications to nicotine replacement therapy.Check my eligibility
What is being tested?
The study tests new programs in rural areas aimed at increasing access to tobacco control services for smokers not yet ready to quit. It compares 'Take a Break' plus Nicotine Replacement Therapy sampling against standard community paramedicine programs with varying levels of implementation support.See study design
What are the potential side effects?
Potential side effects from Nicotine Replacement Therapy may include skin irritation from patches, mouth issues from lozenges/gum, sleep problems, headache and nausea. Individual reactions can vary.

TABR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly from initial training to end of referral period year 1 to year 4 longitudinally
This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly from initial training to end of referral period year 1 to year 4 longitudinally for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Follow-up smoking cessation
Number of participants engaged

TABR Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: The Intervention: Take a Break plus Nicotine replacement therapy (NRT) SamplingExperimental Treatment1 Intervention
Motivational text messages, challenge quizzes, goal-setting, coping mini-games, and recognition & rewards. Nicotine lozenges will be given to all participants in both randomized groups.
Group II: The Enhanced Program: Community Paramedicine Standard Plus Enhanced Implementation ProgramExperimental Treatment1 Intervention
The Enhanced Program will include strategies described in the Standard Program plus training of local champions.
Group III: The Comparison: Nicotine replacement therapy (NRT) Sampling without Take a BreakActive Control1 Intervention
Nicotine lozenges will be given to all participants in both randomized groups. The goal of the comparison group is to isolate the effect of the Take a Break experience.
Group IV: The Standard Program: Community Paramedicine Standard Implementation ProgramActive Control1 Intervention
The standard program will include training, resources, and access to the e-refer tool.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,003,926 Total Patients Enrolled
3 Trials studying Smoking
221 Patients Enrolled for Smoking
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,002 Total Patients Enrolled
64 Trials studying Smoking
53,533 Patients Enrolled for Smoking
University of Massachusetts, WorcesterOTHER
343 Previous Clinical Trials
985,810 Total Patients Enrolled
1 Trials studying Smoking
758 Patients Enrolled for Smoking

Media Library

Take a Break plus Nicotine replacement therapy (NRT) Sampling Clinical Trial Eligibility Overview. Trial Name: NCT05790486 — N/A
Smoking Research Study Groups: The Intervention: Take a Break plus Nicotine replacement therapy (NRT) Sampling, The Comparison: Nicotine replacement therapy (NRT) Sampling without Take a Break, The Enhanced Program: Community Paramedicine Standard Plus Enhanced Implementation Program, The Standard Program: Community Paramedicine Standard Implementation Program
Smoking Clinical Trial 2023: Take a Break plus Nicotine replacement therapy (NRT) Sampling Highlights & Side Effects. Trial Name: NCT05790486 — N/A
Take a Break plus Nicotine replacement therapy (NRT) Sampling 2023 Treatment Timeline for Medical Study. Trial Name: NCT05790486 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still open for the current research project?

"Per the information found on clinicaltrials.gov, this trial is not enrolling patients at present. The study was first published on May 1st 2023 and had its last edit made to it on March 17th 2023. As of now, there are 213 other medical trials actively recruiting participants for their studies instead."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Take A Break - Rural
2023. "Take A Break - Rural". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05790486.
~533 spots leftby Dec 2026
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