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Health Behavior Change Intervention for Smoking Cessation

N/A
Waitlist Available
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
current use of medications known to interact with smoking cessation
weight loss of 20 lbs or more within the past 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2, 3 months post-quit
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether an 8-week intervention of self-regulation strategies + large changes for weight gain prevention can help people who are overweight or obese to quit smoking cigarettes, and whether this is more effective than an 8-week intervention of healthy lifestyle education.

Who is the study for?
This trial is for overweight or obese individuals who smoke at least 5 cigarettes a day, want to quit smoking without gaining weight, and are motivated to stop. They must have a BMI of 25 or higher and be able to use a smartphone or tablet. People with severe psychiatric disorders, recent substance abuse treatment, current smoking cessation or weight loss treatments are excluded.
What is being tested?
The study tests if teaching self-regulation strategies for preventing weight gain before quitting smoking helps more than just healthy lifestyle education. Participants will get either an 8-week course on these strategies followed by an 8-week smoking cessation program, or the same duration of lifestyle education then quitting help.
What are the potential side effects?
Possible side effects may include discomfort from nicotine replacement therapy (like skin irritation from patches or mouth issues from lozenges), stress due to behavior change efforts, and potential withdrawal symptoms associated with quitting smoking.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking medication that affects smoking cessation.
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I have lost 20 lbs or more in the last 6 months.
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My mental health medications are not yet stable.
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I use tobacco or nicotine products more than once a week, but not including e-cigarettes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 2, 3 months post-quit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 2, 3 months post-quit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment attendance
Weight Change
Secondary study objectives
7-day point-prevalence abstinence from smoking
Achievement of ≥50% reduction in cigarettes per day smoked
Duration of longest period of abstinence from smoking
+1 more
Other study objectives
Delay discounting
Negative affect
Self-efficacy for quitting smoking
+3 more

Awards & Highlights

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: Self-Regulation strategies + large changes (SR)Experimental Treatment2 Interventions
This arm will receive the Self-Regulation strategies + large changes (SR) intervention followed by smoking cessation treatment
Group II: Healthy Lifestyle Education (LE)Active Control2 Interventions
This arm will receive the healthy Lifestyle Education (LE) intervention followed by smoking cessation treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Self-Regulation strategies + large changes (SR)
2021
N/A
~60

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor
465 Previous Clinical Trials
698,975 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,579 Previous Clinical Trials
3,316,870 Total Patients Enrolled

Media Library

Healthy Lifestyle Education (LE) Clinical Trial Eligibility Overview. Trial Name: NCT05136430 — N/A
Smoking Cessation Research Study Groups: Self-Regulation strategies + large changes (SR), Healthy Lifestyle Education (LE)
Smoking Cessation Clinical Trial 2023: Healthy Lifestyle Education (LE) Highlights & Side Effects. Trial Name: NCT05136430 — N/A
Healthy Lifestyle Education (LE) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05136430 — N/A
~14 spots leftby Nov 2025