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Mindfulness-Based Smoking Cessation for Smoking

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks after the start of treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am 18 years old or older.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Craving and withdrawal (Wisconsin Smoking Withdrawal Scale [WSWS])
Mindfulness
Dispositional mindfulness (Mindful Attention Awareness Scale [MAAS])
+8 more

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
Self-help materials
2000
Completed Phase 4
~1220
Nicotine
FDA approved
iQuit Mindfully
2017
N/A
~80

Find a Location

Who is running the clinical trial?

George Washington UniversityOTHER
243 Previous Clinical Trials
453,214 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,626 Previous Clinical Trials
40,927,158 Total Patients Enrolled
Georgia State UniversityLead Sponsor
56 Previous Clinical Trials
24,572 Total Patients Enrolled

Media Library

Smoking/Cigarette Smoking Research Study Groups: Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully, iQuit Mindfully, Mindfulness-based Addiction Treatment (MBAT), Usual Care

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What have been the findings of prior investigations into Self-help materials?

"At present, there are 71 clinical trials underway investigating Self-help materials. 5 of those active experiments have progressed to Phase 3. Most studies on this treatment take place in Greenville, South carolina; however, it is being tested across 204 different sites globally."

Answered by AI

Is enrollment still available for this research endeavor?

"According to clinicaltrials.gov, this research project is actively recruiting participants and was first shared on July 1st 2021 with the most recent edit made on July 26th 2022."

Answered by AI

To what extent is this experiment being populated by participants?

"Affirmative. According to the information publicly accessible on clinicaltrials.gov, this medical study is looking for participants at present time. This trial commenced its recruitment process on July 1st 2021 and was most recently modified on July 26th 2022 with a goal of enrolling 485 patients from one site."

Answered by AI

What goals are being sought after by this research project?

"This 24 week trial is associated with the primary outcome of ascertaining how many participants are able to refrain from smoking. Secondary outcomes include Self-efficacy (Self-Efficacy Scale), Home mindfulness practice (number of days per week), and Dispositional mindfulness (Mindful Attention Awareness Scale [MAAS]). These will be evaluated based on questionnaires, where higher scores denote greater success in each measure."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
Georgia
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Georgia State University
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I really want to stop smoking cigarettes and help others who might be battling stress related addiction.
PatientReceived no prior treatments
~85 spots leftby Nov 2024