Varenicline and Combined NRT for Smoking Cessation

What Was Tested

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

This randomized pilot phase IV trial studies the side effects and how well varenicline works compared to nicotine replacement therapy in helping patients that smoke to quit.

Varenicline is a drug that acts the same way as nicotine in the brain but is not habit-forming.

Nicotine replacement therapy consists of nicotine patches and lozenges.

It had two arms (groups): Group I (varenicline and placebo) (experimental) and Group II (placebo, nicotine patch and lozenge) (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive varenicline orally (PO) once daily (QD) or twice daily (BID), placebo patches QD, and placebo lozenges PO QD beginning on day 9 and continue for 6 weeks.

Patients who are abstinent at week 6 will continue treatment for an additional 6 weeks.

Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment.

Who Took Part

The registry lists 631 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Interested in treatment that might change smoking behavior. Able to follow verbal and written instructions in English and complete all aspects of the study. Provide informed consent and agree to all assessments and study procedures. Have an address and telephone number where he/she may be reached. Be the only participant in his/her household.

The full record lists 6 inclusion and 18 exclusion criteria; among the exclusions: current enrollment or plans to enroll in another smoking cessation program in the next 12 months; plan to use other nicotine substitutes (i.e., over-the-counter \[otc\] or prescription medication for smoking cessation) or smoking cessation treatments in the next 12 months; uncontrolled hypertension (systolic blood pressure; \[sbp\] greater than 180 or diastolic blood pressure; \[dbp\] greater than 110).

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

Those kept unaware of assignments: participant and investigator.

It started in 2015-05-14 with completion listed for 2025-06-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Smoking Abstinence (time frame: 12 weeks).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 631 people.

With 631 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.