Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

What Was Tested

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

RATIONALE: Stop-smoking plans, including counseling and nicotine replacement therapy, may help smokers quit smoking.

PURPOSE: This randomized phase III trial is studying counseling and the nicotine lozenge to see how well they work compared to counseling and the nicotine patch in helping smokers quit smoking.

It had two arms (groups): Arm I (experimental) and Arm II (experimental).

Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).

The registry classes the interventions as drug.

More on the Plan

Participants are randomized to 1 of 2 intervention arms.

All participants undergo smoking cessation counseling in weeks 1, 3, 5, 7, and 9.

Continuous abstinence will be measured at week 27.

PROJECTED ACCRUAL: A total of 700 participants will be accrued for this study.

Who Took Part

Enrollment: 642 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Smokes at least 10 cigarettes a day on average for the past year. Able to use nicotine replacement therapy. Able to communicate in English. Must reside in the geographic area for ≥ 6 months. Current asthma, ulcer, or diabetes allowed provided medical clearance from the participant's physician is obtained.

The full record lists 32 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a randomized, factorial 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.

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

It started in 2006-02 with completion listed for 2009-08.

It ran at 10 sites in United States (10).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 24-hour Point Prevalence Abstinence at the 6-month Follow up (time frame: 6-months).

It also tracked 1 secondary outcome, for example Rate of Compliance During the First 2 Weeks.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 642 people.

With 642 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.