Combination of Nicotine Replacement Therapy (NRT) and Varenicline to Increase Cessation of Tobacco (CONVICT Study)

What Was Tested

In this phase 3 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

This proof-of-principle placebo-controlled double-blind study will examine whether combining NRT and varenicline provides better withdrawal and craving relief than varenicline alone.

It had two arms (groups): Varenicline + Active Patch (experimental) and Varenicline + Placebo Patch (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 117 actual participants took part.

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

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

Examples of who could join: Smokers seeking treatment. Aged 18 and over. Consenting to take part in the trial.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: pregnant or breastfeeding; end-stage renal disease; unable to fill in questionnaires in english.

How the Study Was Run

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

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.

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

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

It started in 2011-04 with completion listed for 2011-10.

It ran at 2 sites in United Kingdom (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (time frame: 1 week).

It also tracked 4 secondary outcomes, for example Validated abstinence rates over weeks 1-12 post target quit date, Rating of withdrawal symptoms up to 4-weeks post quitting assessed by Mood and Physical Symptoms Scale, Profile of all adverse effects reported up to 12-weeks post quitting and Ratings of urges to smoke 24 hours after the target quit date.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Therapeutic nicotine (patch, non-peptide) in 117 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.