Smoking Cessation Intervention

What Was Tested

In this phase 4 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

As such, in the context of a Stage-I randomized controlled trial (RCT), this study will examine (1) treatment characteristics and delivery, treatment integrity, dropout, and acceptability, (2) smoking outcomes such as lapse, relapse, and abstinence measures, and (3) changes decision-making that result from a novel intervention informed by behavioral analysis and social cognition.

It had two arms (groups): Spotlight on Smoke-Free Living (experimental) and Standard Informational Treatment (active comparator).

The registry classes the interventions as behavioral and drug.

More on the Plan

Behavioral interventions for smoking cessation have insufficiently integrated the findings from basic research on decision-making processes.

Thus, there is extensive laboratory-based research indicating the potential for laboratory-based manipulations that affect decision making relevant for smoking, the examination of a coherent intervention that capitalizes on this knowledge is limited.

The proposed research is the first step toward synthesizing insights from the research domains of addiction, behavioral analysis, and social cognition into a cohesive formulation with potential impact on smoking cessation.

Who Took Part

Enrollment: 23 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: Current cigarette smoker (verified with an expired carbon monoxide level of at least 4 ppm of expired air),. At least 18 years of age,. With a desire to quit smoking in the next month (at least 5 on a 10-point scale).

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: having uncontrolled serious psychiatric or medical illnesses,; having recent suicide attempts or ideation,; meeting contraindications for use of nicotine replacement products,.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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.

In this single-blind Therapeutic nicotine (patch, non-peptide) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2016-12-13 with completion listed for 2018-08-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 7-day smoking point prevalence (time frame: 13 weeks). Delay Discounting (time frame: 13 weeks).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 23 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); 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.