Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation

What Was Tested

In this phase 2 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): Varenicline and Placebo Patch (placebo comparator) and Varenicline and Nicotine Patch (active comparator).

Varenicline and Nicotine Patch (placebo).

The registry classes the interventions as drug.

More on the Plan

This is a phase-II multicenter study involving 438 smokers, to be conducted at 7 sites in South Africa, over 6 months.

The nicotine patch (active and placebo) will be provided by McNeil.

The patch will be given 2 weeks prior TQD.

Treatment duration from TQD is 12 weeks with varenicline being tapered off during week 13.

Who Took Part

The registry lists 446 actual participants took part.

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

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

Examples of who could join: Current cigarette smokers, male and female, aged between 18-75 years (both limits inclusive), and who are motivated to stop smoking. Women of child-bearing potential (WCBP) may be included provided they are not pregnant, not nursing, and meet all of the following criteria:. Negative screening test (beta-HCG) at screening. Patients must have no serious or unstable disease in the past 6 months. Only one subject per household may participate.

The full record lists 9 inclusion and 20 exclusion criteria; among the exclusions: patients currently suffering from depression or who have been diagnosed with depression or treated with anti-depressants within the past 12 months; patients with a past of present history of psychosis, panic disorder, or bipolar disorder; patients with severe chronic obstructive pulmonary disease (copd).

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind 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.

As a double-blind Therapeutic nicotine (patch, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2011-04 with completion listed for 2013-04.

It ran at 7 sites in South Africa (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: continuous abstinence (CAR) from weeks 9 to 12 of treatment (time frame: 3 months).

It also tracked 1 secondary outcome, for example CAR from weeks 9 to 24.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 446 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.