Computer-Assisted Counseling in Helping African American Smokers Stop Smoking

What Was Tested

In this not phased trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

RATIONALE: Stop-smoking plans using a nicotine patch, in-person counseling, and computer-assisted counseling may help people stop smoking.

PURPOSE: This randomized clinical trial is studying how well computer-assisted counseling helps African American smokers stop smoking.

It had three arms (groups): Standard Care Group (active comparator), Computer Treatment Group (CDT) (active comparator) and CDT Pilot (experimental).

Written self-help materials, counseling, and 6-week nicotine patch supply.

Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment.

Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment.

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

More on the Plan

OUTLINE: This is a randomized study.

A subset of 20 participants are assigned to arm II for pilot testing.

All other participants are randomized to 1 of 2 intervention arms. * Arm I (standard care \[SC\]): Participants receive nicotine patch therapy on days -5 to 31.

Participants also receive a Pathways to Freedom self-help guide and undergo 5 in-person counseling sessions based on the Treating Tobacco Use and Dependence Clinical Practice Guideline.

Who Took Part

The registry lists 462 actual participants took part.

It was open to people of any sex aged from 21 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 21 to 65 years. Current Smoker (history of at least 5 cigarettes/day for the last year). Motivated to quit within the next 14 days. Participants must provide a viable home address and functioning home telephone number. Can speak, read, write in English at a sixth-grade literacy level.

The full record lists 8 inclusion and 7 exclusion criteria; among the exclusions: contraindication for nicotine patch use; active substance dependence (exclusive of nicotine dependence); regular use of tobacco products other than cigarettes (cigars, pipes, smokeless).

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2002-04-08 with completion listed for 2006-08-17.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Smoking status by SRNT Smoking Status Questionnaire 6 months after treatment (time frame: 6 months after treatment).

It also tracked 1 secondary outcome, for example Contemplating smoking by Contemplation Ladder 6 months after treatment.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 462 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.