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Mindfulness-Based Smoking Cessation for Smoking

N/A

Waitlist Available

Led By Claire A Spears, Ph.D

Research Sponsored by Georgia State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Be older than 18 years old

Must not have

Current suicidal ideation

Current use of tobacco cessation medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks after the start of treatment

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial will test if a mindfulness-based text messaging program can help people quit smoking, either on its own or when used with in-person counseling. It will also look at how mindfulness training might impact smoking cessation.

Who is the study for?

This trial is for English-speaking adults in the greater Atlanta area who smoke more than 3 cigarettes a day and want to quit within the next month. They must have a working phone and home address. Pregnant, lactating women, or those with substance abuse issues, suicidal thoughts, or using other cessation aids are excluded.

What is being tested?

The study tests 'iQuit Mindfully', a text messaging program aimed at helping people stop smoking. It's being evaluated alone and alongside in-person counseling to see how effective it is compared to standard methods like self-help materials and nicotine replacement therapy.

What are the potential side effects?

Potential side effects may include skin irritation from nicotine patches, mouth problems from lozenges, and typical withdrawal symptoms such as irritability, cravings, or difficulty concentrating when quitting smoking.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently having thoughts about harming myself.

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I am currently using medication to help me stop smoking.

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I cannot use nicotine patches or lozenges due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks after treatment 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, 12 weeks

Number of participants with confirmed smoking abstinence, 24 weeks

Number of participants with confirmed smoking abstinence, 8 weeks

Secondary study objectives

Craving and withdrawal (Wisconsin Smoking Withdrawal Scale [WSWS])

Mindfulness

Dispositional mindfulness (Mindful Attention Awareness Scale [MAAS])

+8 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: iQuit MindfullyExperimental Treatment3 Interventions

Participants will receive iQuit Mindfully text messages and nicotine replacement therapy (NRT). NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke \>10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute "Clearing the Air" booklet and a referral to the Tobacco Cessation Quitline.

Group II: Mindfulness-based Addiction Treatment (MBAT) + iQuit MindfullyExperimental Treatment4 Interventions

Participants will receive virtual group counseling based on the Mindfulness-Based Addiction Treatment (MBAT) group protocol, iQuit Mindfully text messages, and nicotine replacement therapy (NRT). MBAT consists of 8 weekly 2-hour sessions. NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke \>10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute "Clearing the Air" booklet and a referral to the Tobacco Cessation Quitline.

Group III: Mindfulness-based Addiction Treatment (MBAT)Experimental Treatment3 Interventions

Participants will receive virtual group counseling based on the Mindfulness-Based Addiction Treatment (MBAT) group protocol and nicotine replacement therapy (NRT). MBAT consists of 8 weekly 2-hour sessions. NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke \>10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute "Clearing the Air" booklet and a referral to the Tobacco Cessation Quitline.

Group IV: Usual CareActive Control2 Interventions

Participants in the usual care condition are provided with nicotine replacement therapy (NRT). NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke \>10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute "Clearing the Air" booklet and a referral to the Tobacco Cessation Quitline.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

iQuit Mindfully

2017

N/A

~80

Nicotine

FDA approved

Self-help materials

2000