Niccine®, a nicotine vaccine, for relapse prevention: a phase II, randomized, placebo-controlled, multicenter clinical trial.

What Was Tested

This randomized controlled trial looks at Therapeutic nicotine (patch, non-peptide).

Niccine® is a nicotine hapten tetanus-toxoid conjugate vaccine.

Who Took Part

The study group was 98, subjects.

The age groups tagged for this paper are adults and middle-aged adults, both men and women.

Cigarette smokers (n = 355) aged 25-50 years were enrolled in a randomized, double-blind, parallel group 1-year trial encompassing 16 visits and 16 telephone calls.

Between Days 56-98, subjects were treated with varenicline to aid cessation, targeted for Day 70.

How the Study Was Run

The design is described as randomized, double-blind, placebo-controlled and parallel-group.

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.

Neither the subjects nor the staff measuring them knew who was on Therapeutic nicotine (patch, non-peptide), so expectations could not easily colour the readings.

A placebo (an inactive look-alike) gave the Therapeutic nicotine (patch, non-peptide) group a baseline to be compared against.

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

Only individuals abstinent between Days 90-98 (n = 265) were allowed to continue to 1 year (n = 219).

What Was Measured

Topics PubMed links to this paper include Nicotine, Smoking Cessation and Vaccines.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Therapeutic nicotine (patch, non-peptide) in 98, subjects.

The abstract goes on to report its results in about 5 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2013 (Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco), a journal based in England.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.