Treatment of Smoking Lapses and Relapses

What Was Tested

The trial (phase 4) is built around Therapeutic nicotine (patch, non-peptide).

Many smokers who try to stop smoking with nicotine medications (NM) such as gum, lozenge and patch, go back to smoking (i.e., a slip or lapse).

Currently, labeling on many NM products tells smokers who lapse while using NM to stop NM.

It had two arms (groups): nicotine patch, experimental use (experimental) and nicotine patch, labeled use (active comparator).

Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.

The registry classes the interventions as drug.

More on the Plan

To test whether the incidence of adverse events (AEs) during post-lapse patch use is minimal.

Purpose: Over the counter (OTC) NRT is, by far, the most common treatment for smoking cessation in the United States (Cokkinides, Ward, Jemel, \& Thun, 2005).

Study design: The investigators are proposing a parallel groups randomized controlled trial (RCT) in which all treatment and monitoring occur via phone, and medication via mail.

The investigators will recruit about 770 smokers to receive phone counseling before and after the quit date and nicotine patches for 10 weeks after the quit date.

Who Took Part

701 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: At least 18 years old. Daily smoker of 10 or more cigarettes per day for at least 1 year. State they plan to probably or definitely quit smoking in the next month. Have a home or cell phone. Willing to use nicotine patch.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: use of non-cigarette tobacco in the last month; use of a smoking cessation medication or smoking cessation counseling in the last month; medical contraindication to use of patch.

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.

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

It started in 2013-03 with completion listed for 2016-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Point-prevalent Abstinence at 4 Months (time frame: 4 months after the quit date).

It also tracked 2 secondary outcomes, for example Mediators of Effect of Post-lapse Nicotine Replacement Therapy Use on Abstinence and Adverse Drug Effects.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 701 people.

With 701 participants it is a large trial for this field.

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.