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Behavioral Intervention

Smoking Cessation Program for Smoking (STEP3 Trial)

Phase 3
Recruiting
Led By Jasper Smits, PhD
Research Sponsored by Jasper A. Smits
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Daily smoker, ≥5 cigarettes (including e-cigarettes, little cigars/cigarillos) for ≥1 year
Adult (age ≥ 18)
Must not have
Receiving current intervention for smoking cessation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up protocol week 54, which is 48 weeks (12 months) after the quit attempt (set at week 6)
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is researching if a YMCA smoking cessation program can be personalized to help people with anxiety-related smoking relapse.

Who is the study for?
This trial is for adults who smoke at least 5 cigarettes daily for over a year, have high anxiety sensitivity, and want to quit smoking. They must be medically cleared to participate and not already exercising regularly or receiving other smoking cessation help.
What is being tested?
The study tests if personalized smoking cessation programs that include aerobic exercise, counseling, and nicotine patches are effective for smokers with high stress sensitivity when implemented by the YMCA in diverse communities.
What are the potential side effects?
Possible side effects from the interventions could include skin irritation from nicotine patches, muscle soreness from exercise, and emotional discomfort during counseling sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been smoking at least 5 cigarettes a day for over a year.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently getting help to stop smoking.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~protocol week 54, which is 48 weeks (12 months) after the quit attempt (set at week 6)
This trial's timeline: 3 weeks for screening, Varies for treatment, and protocol week 54, which is 48 weeks (12 months) after the quit attempt (set at week 6) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
7-day point prevalence abstinence (PPA) at 6-month follow-up
Secondary study objectives
7-day point prevalence abstinence (PPA) at 12-month follow-up
7-day point prevalence abstinence (PPA) at 9-month follow-up

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: High-Intensity Aerobic ExerciseExperimental Treatment3 Interventions
Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 60-85% of the their heart rate reserve.
Group II: Low-Intensity Aerobic ExerciseActive Control3 Interventions
Participants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 20-40% of the their heart rate reserve.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Counseling
2017
Completed Phase 4
~1830
Aerobic Exercise
2013
Completed Early Phase 1
~1350
Nicotine patch
2015
Completed Phase 4
~6130

Find a Location

Who is running the clinical trial?

University of HoustonOTHER
150 Previous Clinical Trials
47,559 Total Patients Enrolled
Oklahoma State UniversityOTHER
48 Previous Clinical Trials
7,881 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,107 Total Patients Enrolled
~240 spots leftby Jun 2027
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