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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:Select...
I am taking medication that affects smoking cessation.
Select...
I have lost 20 lbs or more in the last 6 months.
Select...
My mental health medications are not yet stable.
Select...
I use tobacco or nicotine products more than once a week, but not including e-cigarettes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 2, 3 months post-quit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 2, 3 months post-quit
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 moreOther study objectives
Delay discounting
Negative affect
Self-efficacy for quitting smoking
+3 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to fully understand the information provided in the consent form.You have recently shown signs of an eating disorder, alcohol or drug addiction, severe depression, or thoughts of harming yourself.I am taking medication that affects smoking cessation.You have a body mass index (BMI) of 25 or higher.I have been diagnosed or treated for an eating disorder or severe psychiatric disorder.I am motivated to quit smoking.I have lost 20 lbs or more in the last 6 months.I am currently trying to quit smoking or lose weight with medication.I want to avoid gaining weight while I quit smoking.You need to have a smartphone or tablet.You have smoked at least five cigarettes a day within the past year.You have reported being diagnosed or treated for drug or alcohol addiction within the past 6 months (except if you are undergoing maintenance treatment).My mental health medications are not yet stable.I have a serious health condition.I use tobacco or nicotine products more than once a week, but not including e-cigarettes.
Research Study Groups:
This trial has the following groups:- Group 1: Self-Regulation strategies + large changes (SR)
- Group 2: Healthy Lifestyle Education (LE)
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.
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