Effects of Smoking Environments on Craving and Smoking (CameraCue2.0)

What Was Tested

The trial (not phased) is built around Therapeutic nicotine (patch, non-peptide).

The goal of this study is to evaluate the effects of varenicline versus nicotine replacement versus placebo on personal smoking environment cue (PSE) reactivity.

The investigators propose to identify 120 regular cigarette smokers who will complete 10 visits (1 screening visit, 1 training visit, 1 camera turn-in 2 cue exposure sessions and 4 post-quit medication check sessions).

It had three arms (groups): NRT (placebo comparator), VAR (placebo comparator) and PLAC (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 125 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Between the ages of 18 and 60. An expired CO concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine \>1000 ng/mL (NicAlert = 6). Interest in quitting smoking within the timeframe of the experiment. Ability to identify 4 personal smoking and 4 personal non-smoking places.

The full record lists 6 inclusion and 23 exclusion criteria; among the exclusions: immediate or no desire to quit smoking;; inability to attend all required experimental sessions;; use of psychoactive medications;.

How the Study Was Run

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

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 and investigator.

It started in 2016-01 with completion listed for 2019-01-07.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Change in Craving Score During Cue Exposure Task (time frame: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)). Change in Latency to Smoke During Cue Exposure Task (time frame: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)). Change in Smoke Intake During Cue Exposure Task (time frame: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 125 people.

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.