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Mindfulness-Based Smoking Cessation for Smoking
Phase 4
Recruiting
Led By Taghrid Asfar, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be 18-40 years old (young cancer survivors)
Cancer survivors (based on the NCI definition - "a person is considered to be a survivor from the time of diagnosis until the end of life" National Cancer Institute Dictionary of Cancer Terms, 2014)52
Timeline
Screening 1 day
Treatment 1 months
Follow Up 3 months
Awards & highlights
Summary
This trial will test whether a mindfulness-based smoking cessation program can help cancer survivors quit smoking.
Who is the study for?
This trial is for young adult cancer survivors aged 18-40 who smoke at least 5 cigarettes a day and are interested in quitting within the next month. Participants must own a smartphone, not be pregnant or planning pregnancy soon, and have no plans to move shortly. Those with cognitive impairments, current smoking cessation treatment, or substance abuse issues cannot join.
What is being tested?
The study tests a mindfulness-based program to help stop smoking. It includes an orientation session, group Mindfulness Training (MT) sessions, two follow-up calls, use of the Craving-to-Quit app and Nicoderm C-Q patches for nicotine replacement therapy along with brief advice and self-help materials.
What are the potential side effects?
Possible side effects may include skin irritation from the nicotine patch and typical challenges related to quitting smoking such as increased appetite, mood swings, irritability, difficulty concentrating and cravings.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 40 years old.
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I have been diagnosed with cancer at some point in my life.
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You have smoked at least 5 cigarettes per day in the last year.
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You have an Apple or Android smartphone.
Timeline
Screening ~ 1 day0 visits
Treatment ~ 1 months0 visits
Follow Up ~ 3 months0 visits
Screening ~ 1 day
Treatment ~ 1 months
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with confirmed smoking abstinence
Secondary study objectives
Acceptability
Attrition
Change in number of cigarettes smoked per day
+5 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: In-person Mindfulness TrainingExperimental Treatment3 Interventions
Participants in this group will receive twice weekly group sessions (eight total during 4 weeks) that were manualized and delivered by instructors experienced in Mindfulness Training (MT) (a single therapist with >4 years of training in MT).
Group II: Craving-to-Quit appExperimental Treatment4 Interventions
Participants in this group will receive one in-person orientation session, 6-week supply of NRT, the "Craving-to-Quit" app, and two brief follow-up phone calls.
Group III: Usual CareActive Control3 Interventions
Participants in this group will receive a brief advice to quit smoking, 6-week supplies of nicotine replacement therapy (NRT), and self-help materials to quit smoking.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicoderm C-Q Transdermal Product
2019
Completed Phase 4
~40
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
935 Previous Clinical Trials
422,157 Total Patients Enrolled
Taghrid Asfar, MDPrincipal Investigator - University of Miami
University of Miami
3 Previous Clinical Trials
781 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a mental or cognitive condition that makes it difficult to participate in mindfulness treatment.I am between 18 and 40 years old.You have smoked at least 5 cigarettes per day in the last year.I have been diagnosed with cancer at some point in my life.You have smoked at least 5 cigarettes per day in the last year.I am between 18 and 40 years old.You have an Apple or Android smartphone.I don't have any plans to move in the next three months.You are currently receiving treatment for quitting smoking, alcohol addiction, or drug addiction.I am ready to try quitting smoking within the next month.I am ready to try quitting smoking within the next month.You are pregnant.The patient was able to consent to the surgeryYou have an Apple or Android smartphone.I am under the age of 18.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: In-person Mindfulness Training
- Group 3: Craving-to-Quit app
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 1 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Tobacco Smoking Patient Testimony for trial: Trial Name: NCT04038255 — Phase 4
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