Applying mHealth to Tobacco-related Health Disparities

What Was Tested

This registered early phase 1 trial tested Therapeutic nicotine (patch, non-peptide).

The purpose of this study is to better understand what happens when someone attempts to quit smoking.

It had 1 arm (groups): Smoking Cessation Therapy (experimental).

Participants will receive 6 weeks of the nicotine patch therapy and brief counseling sessions. Participants will also receive mindfulness strategies for 10 days during both the pre- and post-quit periods via smartphone to aid in their cessation attempt. AutoSense will be worn to detect stress and lapse throughout the 10 day period.

The registry classes the interventions as behavioral, drug and other.

More on the Plan

Investigators will provide participants with nicotine patches, smoking cessation treatment that will include brief counseling sessions (10-15 minutes each), and text messages sent to their provided study phone throughout the day.

These messages will be short (1-3 minutes long) and will ask participants to do things like focus on the present moment, pay attention to their breathing, and be aware of their current thoughts.

Participants will be asked to wear equipment throughout the day that will measure their physiology and smoking behavior.

The key outcome and hypothesized mechanisms (i.e., lapse and stress) will be measured objectively and automatically using AutoSense.

Who Took Part

The registry lists 50 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Smoked a minimum of 3 cigarettes per day over the past year. Expired carbon monoxide reading ≥ 6. Motivated to quit within the next 30 days. Valid home address. Functioning telephone number.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: contraindication for the nicotine patch (e.g., heart attack, angina, skin allergies) unless a doctor's note is provided; endorse current psychosis; have a pacemaker or implanted device.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2018-07-16 with completion listed for 2020-12-14.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Rate of Smoking Lapse (time frame: Up to 36 months). Rate of Stress (time frame: Up to 36 months).

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Therapeutic nicotine (patch, non-peptide) in 50 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.