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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)

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

STEP3 Trial 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.Check my eligibility

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.See study design

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.

STEP3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been smoking at least 5 cigarettes a day for over a year.

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I am 18 years old or older.

STEP3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ protocol week 54, which is 48 weeks (12 months) after the quit attempt (set at week 6)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

7-day point prevalence abstinence (PPA) at 6-month follow-up

Secondary outcome measures

7-day point prevalence abstinence (PPA) at 12-month follow-up

7-day point prevalence abstinence (PPA) at 9-month follow-up

STEP3 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

~1970

Aerobic Exercise

2013

Completed Early Phase 1

~1310

Nicotine patch

2015

Completed Phase 4

~7450

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of HoustonOTHER

147 Previous Clinical Trials

47,118 Total Patients Enrolled

Oklahoma State UniversityOTHER

46 Previous Clinical Trials

7,912 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,081 Total Patients Enrolled

1 Trials studying Nicotine Addiction

20 Patients Enrolled for Nicotine Addiction

Frequently Asked Questions

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

What has the FDA sanctioned regarding High-Intensity Aerobic Exercise?

"There is prior clinical data supporting the security of High-Intensity Aerobic Exercise, so it earned a score of 3."

Answered by AI

Is there any capacity left to join this medical trial?

"Clinicaltrials.gov has not indicated that this particular trial is actively recruiting participants at present. It was first published on October 1st 2023 and last adjusted on September 13th of the same year; however, there are 115 other studies searching for volunteers currently."

Answered by AI