Development of a mHealth Intervention for Ambivalent Smokers

What Was Tested

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

The current pilot study will assess the feasibility and acceptability of a novel mHealth app designed for people who are ambivalent about quitting smoking.

It had two arms (groups): Control (active comparator) and Experimental (experimental).

The registry classes the interventions as device and drug.

Who Took Part

57 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: 18 years or older;. Can speak/read English;. Own and regularly use an eligible smartphone;. No vision impairments;. Willing to install and use the study program;.

The full record lists 9 inclusion and 6 exclusion criteria; among the exclusions: smoke less than 10 cigarettes per day; self-report a lifetime history of dementia, manic depression, bipolar disorder, or schizophrenia;; have medical contraindications for nicotine replacement therapy;.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

As a double-blind Therapeutic nicotine (patch, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2020-12-16 with completion listed for 2021-09-27.

It ran at 1 site in United States.

Its stated primary purpose is device feasibility.

What Was Measured

Primary outcome: Program Engagement (time frame: Assessed at 3-month follow-up). Quit Attempt Lasting at Least 24 Hours (time frame: Assessed at 3-month follow-up). Not Smoking (Even a Puff) in the Last 7 Days (time frame: Assessed at 3-month follow-up).

It also tracked 16 secondary outcomes, for example Satisfaction With Assigned App, Satisfaction With Assigned App, Helpfulness of Assigned App, Helpfulness of Assigned App, Program Engagement - Earned Badges and Program Engagement - Earned Badges.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Therapeutic nicotine (patch, non-peptide) in 57 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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