Evaluation of Learning-Theory-Based Smoking Cessation Strategies

What Was Tested

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

This clinical trial tested whether a new treatment designed to help smokers prepare to quit smoking by practicing quitting several times helped more smokers quit and stay quit than standard treatment with nicotine patch and smoking cessation counseling.

The practice quitting treatment tested involved quitting for progressively longer periods of time tailored to individual patterns of smoking.

This clinical trial also tested whether non-nicotine cigarettes can help smokers become smoke free after slipping during a stop smoking attempt.

It had four arms (groups): Standard treatment (active comparator), Standard treatment+practice quitting (experimental), Very low nicotine cigarettes (experimental) and Advice and encouragement only (no intervention).

In this arm, smokers receive a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking.

In this arm, participants receive standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.

The registry classes the interventions as behavioral and drug.

More on the Plan

Compensation will be provided for completing these cellular telephone phone reports.

Who Took Part

Enrollment: 93 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. Smoke cigarettes daily. Motivated to quit smoking. Able to read and write English. Willing and able to complete study visits and cell phone calls.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: pregnancy, breastfeeding, planning on becoming pregnant during the study; recent heart attack or heart surgery, heart disease, unstable angina; allergy to adhesives.

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.

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 2012-06 with completion listed for 2013-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 4-week Abstinence (time frame: 4 weeks).

It also tracked 3 secondary outcomes, for example 10-week Abstinence, Mediators of Treatment Effects: Confidence in Quitting in the Weeks Leading up to the Target Quit Date and Prolonged Abstinence.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 93 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.