Pager-Assisted Smoking Cessation Treatment

What Was Tested

The trial (not phased) is built around Therapeutic nicotine (patch, non-peptide).

The hypothesis is that the proportion of biochemically-verified quitters at 3 and 12 months in the study arm randomized to receive therapeutic messages on alphanumeric pagers for 3 months along with individual smoking cessation counseling and nicotine patches will be greater that the proportion of biochemically-verified quitters who receive only individual smoking cessation counseling and nicotine patches.

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

Participants in the Pager Arm will be provided with alphanumeric pagers and will receive therapeutic messages on these pagers for 3 months in addition to individual smoking cessation counseling and nicotine patches.

Participants in the Control Arm will receive individual smoking cessation counseling and nicotine patches.

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

More on the Plan

A total of 224 current smokers were enrolled in a randomized controlled smoking cessation trial.

Participants were community-living adult smokers of ≥10 cigarettes per day during the pre-enrollment week who were interested in quitting and recruited from the local area by means of print, media, and online advertisements.

To be eligible, they needed to be smoking 10 or more cigarettes per day, aged 18 or older, motivated to quit smoking, prepared to set a quit date, willing to use nicotine patches, and able to come to therapy sessions and be followed by telephone.

Participants in the pager treatment were provided with alpha-numeric pagers free of charge for three months.

Who Took Part

Enrollment: 224 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Smoking 10 or more cigarettes per day. Aged 18 or older. Motivated to quit smoking and prepared to set a quit date. Willing to use nicotine patches. Ability to come to therapy sessions and be followed by telephone.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: individuals who are psychotic; severely depressed; organically brain impaired.

How the Study Was Run

Design: 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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.

It started in 2003-05 with completion listed for 2005-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): biologically-validated point prevalence smoking cessation (time frame: 12 months after enrollment).

It also tracked 1 secondary outcome, for example continuous abstinence from cigarettes "even a puff", tobacco products and nicotine replacement.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 224 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.