Mindful Smoking + Wearable Device for Smoking Cessation

FL
Overseen ByFang Lei, PhD, MSN, MPH, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This pilot randomized controlled trial will test the feasibility of a smoking cessation intervention using mindful smoking practice and a smartphone-based sensor-band among adults who regularly smoke cigarettes.

Participants will be randomized to either an intervention group or a control group. Participants in the intervention group will receive a one-on-one mindful smoking guidance session, instructions for using a smartphone-based sensor-band, a mindfulness practice video, and smoking cessation information. Participants in the control group will receive smoking cessation information. The intervention period will last 8 weeks, with assessments at baseline, 8 weeks, and 4 months after completion of the intervention.

The study will evaluate feasibility, preliminary smoking cessation outcomes, and physiologic parameters including heart rate variation, skin temperature, resting heart rate, respiratory rate, and real-time heart rate during craving and mindful smoking practice.

Who Is on the Research Team?

FL

Fang Lei, PhD, MSN, MPH, RN

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults 18+ who smoke at least 5 cigarettes daily, want to quit in the next month, have a working smartphone and phone number. People can't join if they recently changed medications, have unstable health, use other tobacco products often, are in another quit program, or live with someone else in this study.

Inclusion Criteria

I am 18 years old or older.
Smoking at least 5 cigarettes per day on average over the past 3 months
I want to quit smoking within the next 30 days.
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Exclusion Criteria

I have not changed my medications or had unstable health in the past 3 months.
Active substance dependence other than nicotine
Use of other non-cigarette tobacco products, including e-cigarettes, more than 15 days per month
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a one-on-one mindful smoking guidance session, use a smartphone-based sensor-band, and practice mindful smoking for 8 weeks

8 weeks
1 visit (in-person) for guidance session, ongoing self-management

Follow-up

Participants are monitored for smoking cessation outcomes and physiologic parameters 4 months after intervention completion

4 months
Assessments at 8 weeks and 4 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

  • Mindful Smoking and Sensor-Band Intervention

Trial Overview

The study compares two ways to help people quit smoking: one group gets mindful smoking guidance plus a sensor-band that connects to their smartphone and mindfulness resources; the other group just receives standard information about quitting. Participants are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Mindful Smoking and Sensor-Band InterventionExperimental Treatment1 Intervention
Group II: Smoking Cessation Information ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+