Mobile Media-Rich Interactive Guideline System (MMRIGS) Pilot Study

What Was Tested

This registered not phased trial tested Therapeutic nicotine (patch, non-peptide).

The goal of this research study is to learn about 2 different interactive methods that are designed to help people with HIV/AIDS stop smoking.

It had two arms (groups): Standard Treatment (ST) (experimental) and Automated Treatment (AT) (experimental).

Participants supplied with a 8-week supply of nicotine patches and a smart phone. Participants also receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone. Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months. Participants complete saliva cotinine test 3 months after intervention.

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

More on the Plan

Baseline Questionnaire: If you agree to take part in this study, you will complete a questionnaire on a laptop about your feelings, mood, health, thoughts about smoking, thoughts about quitting smoking, smoking history, and some demographic information such as age, education level, and income level.

This should take about 15-20 minutes to complete.

Study Groups: After completing the questionnaire, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups.

You will have an equal chance of being placed in either group.

Who Took Part

8 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 of age or older. Smoked at least 100 cigarettes in lifetime. Currently smoking 5 or more cigarettes per day. Willing to make a quit attempt within 1 week of enrollment.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: positive history of a medical condition that precludes use of the nicotine patch; current use of nicotine replacement therapy (nrt); current use of other smoking cessation medications (e.g., chantix or zyban).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Being open-label, the Therapeutic nicotine (patch, non-peptide) study did not mask who received what.

It started in 2015-01 with completion listed for 2016-03.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Smoking Abstinence: 3-month Assessment Via Smart Phone (time frame: 3 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 8 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); 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.