Group Therapy for Nicotine Dependence: Mindfulness and Smoking

What Was Tested

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

The goal of this behavioral research study is to create and study a Mindfulness-Based Addiction Treatment (MBAT) for nicotine dependence.

Mindfulness is a method to help focus attention on being in the "here and now." It can be learned through training in how to control one's attention.

It is usually taught through meditation.

It had three arms (groups): Mindfulness-Based Treatment Group (MBAT) (experimental), Standard Care Group (active comparator) and Usual Care Group (active comparator).

MBAT is 6 weeks of nicotine patch therapy; a Self-help guide; and In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence.

Standard Care Group (ST) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline.

Usual Care (UC) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline.

The registry classes the interventions as behavioral and drug.

More on the Plan

This 3-group randomized clinical trial will develop and evaluate a Mindfulness-Based Addiction Treatment (MBAT) for nicotine dependence.

Mindfulness reflects a purposeful control of attention and can be learned through training in attentional control procedures.

Current cigarette smokers (N=550; 400 in formal study; up to 80-150 pilot) will be randomly assigned to Usual Care (UC), Standard Treatment (ST) or MBAT.

UC will be four 5-10 minute counseling sessions following the problem-solving approach in the Treating Tobacco Use and Dependence Clinical Practice Guideline (Guideline).

Who Took Part

Enrollment: 650 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: Age 18 or above. Current smoker with a history of at least five cigarettes/day for the past year. Motivated to quit within the next 30 days (preparation stage). Participants must provide a viable home address and a functioning home telephone number. Can read and write in English.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: contraindication for nicotine patch use; regular use of tobacco products other than cigarettes (cigars, pipes, smokeless tobacco); use of bupropion or nicotine patch replacement products other than the study patches.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2005-04 with completion listed for 2016-09.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Smoking Abstinence (time frame: 4 weeks post quit day (one week following the end of treatment)). Smoking Abstinence (time frame: 26 weeks post quit day). Smoking Abstinence (time frame: 4 weeks post quit day (one week following the end of treatment)).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 650 people.

With 650 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.