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NRT + Quit Practice Strategies for Smoking Cessation (ON-DEQ Trial)
Phase 1 & 2
Recruiting
Led By Amanda Mathew, PhD
Research Sponsored by Rush University Medical Center
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 at 1-month follow-up assessment
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether giving smokers nicotine replacement therapy (NRT) or motivational interviewing (MI) can help them successfully practice quitting.
Who is the study for?
This trial is for English-speaking adults in the continental U.S. who smoke daily (5+ cigarettes) and aren't planning to quit within 30 days but are considering quitting or reducing smoking within 6 months. They must have a smartphone for study procedures. It's not for those who vape daily, are pregnant/breastfeeding, or have had recent heart attacks or strokes.
What is being tested?
The study tests whether Practice Quitting (PQ) counseling, Motivational Interviewing (MI), or Nicotine Replacement Therapy (NRT) sampling helps smokers practice quitting—trying not to smoke temporarily without pressure to quit permanently.
What are the potential side effects?
Possible side effects from NRT may include skin irritation from patches, mouth issues from lozenges, headaches, sleep problems, nausea, and dizziness. Counseling interventions typically do not have physical side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1-month follow-up assessment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1-month follow-up assessment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Any incidence of a quit attempt
Secondary study objectives
Abstinence status at 1-month follow-up
Abstinence status at 3-month follow-up
Abstinence status at 6-month follow-up
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Condition #4Experimental Treatment1 Intervention
NRT sampling = Off Behavioral counseling = Motivational Interviewing
Group II: Condition #3Experimental Treatment2 Interventions
NRT sampling = On Behavioral counseling = Motivational Interviewing
Group III: Condition #2Experimental Treatment1 Intervention
NRT Sampling = Off Behavioral Counseling = Practice Quitting
Group IV: Condition #1Experimental Treatment2 Interventions
NRT Sampling = On Behavioral Counseling = Practice Quitting
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine Replacement Therapy (NRT) Sampling
2014
N/A
~1280
Find a Location
Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
438 Previous Clinical Trials
249,672 Total Patients Enrolled
2 Trials studying Tobacco Use
84 Patients Enrolled for Tobacco Use
Medical University of South CarolinaOTHER
977 Previous Clinical Trials
7,400,137 Total Patients Enrolled
9 Trials studying Tobacco Use
41,586 Patients Enrolled for Tobacco Use
Amanda Mathew, PhDPrincipal InvestigatorRush University Medical Center
1 Previous Clinical Trials
66 Total Patients Enrolled
1 Trials studying Tobacco Use
66 Patients Enrolled for Tobacco Use
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You smoke at least 5 cigarettes every day.I am 18 years old or older.You cannot be someone who plans to stop smoking within the next month.I haven't had a recent heart attack or similar heart issue.I am motivated to quit or reduce smoking within the next 6 months.I haven't had a stroke in the last 3 months.I am not pregnant or breastfeeding, so I can use nicotine replacement therapy.I am willing to quit smoking or reduce it within the next 6 months.I am either male or female.
Research Study Groups:
This trial has the following groups:- Group 1: Condition #1
- Group 2: Condition #4
- Group 3: Condition #2
- Group 4: Condition #3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Tobacco Use Patient Testimony for trial: Trial Name: NCT05513872 — Phase 1 & 2