Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue)

What Was Tested

This registered not phased trial tested Therapeutic nicotine (patch, non-peptide).

The central objective of the project is to evaluate the effect of incorporating smoking related contexts into very low nicotine content (VLNC) cigarette extinction trials on clinically relevant, smoking-related outcomes.

Adult smokers interested in quitting smoking (N=80) will be interviewed and trained to take pictures where they smoke cigarettes.

It had two arms (groups): MCE+ (experimental) and MCE- (Control) (other).

The registry classes the interventions as behavioral and drug.

Who Took Part

Enrollment: 87 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Interest in quitting smoking. An expired carbon monoxide concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine \> 1000 ng/mL to confirm daily smoking (NicAlert=6).

The full record lists 4 inclusion and 19 exclusion criteria; among the exclusions: inability to attend all required experimental sessions; desire to quit smoking prior to the study quit date; a quit attempt resulting in greater than 3 days of abstinence in the past 30 days.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

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

Being open-label, the Therapeutic nicotine (patch, non-peptide) study did not mask who received what.

It started in 2015-10-08 with completion listed for 2017-09-08.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Change in Fagerstrom Test of Nicotine Dependence Score (time frame: baseline - week 6). Number of Participants Who Met Relapse Criteria (time frame: week 16).

It also tracked 4 secondary outcomes, for example Change From Baseline in Number of Usual Brand Cigarettes Smoked (EXT Engagement), Change in Number of Cigarettes Smoked Per Day (EXT Response), Change in Craving Score During MCE Task (MCE Response) and Change in Post-quit Cue-reactivity.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 87 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.