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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 month

Follow Up 3 months

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

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 below

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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 month0 visits

Follow Up ~ 3 months0 visits

Screening ~ 1 day

Treatment ~ 1 month

Follow Up ~3 months

This trial's timeline: 1 day for screening, 1 month for treatment, and 3 months for reporting.

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 more

Awards & Highlights

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.

Trial 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

0 / 6Eligibility criteria met