Impact of Alternative Nicotine-Delivery Products on Combustible Cigarette Use

What Was Tested

The trial (phase 2) is built around Therapeutic nicotine (patch, non-peptide).

The investigators will enroll 180 daily adult smokers who are not planning to quit smoking within the next 30 days into this mixed design study.

It had six arms (groups): Juul + Active Patch in Wk 1 and Placebo Patch in Wk 2 (active comparator), Juul + Placebo Patch in Wk 1 and Active Patch in Wk 2 (active comparator), VLNC + Active Patch in Wk 1 and Placebo Patch in Wk 2 (active comparator), VLNC + Placebo Patch in Wk 1 and Active Patch in Wk 2 (active comparator) and No Product + Active Patch in Wk 1 and Placebo Patch in Wk 2 (other).

Participants will be given Juul e-cigarettes for four weeks; in Switch Week 1, participants also will use active nicotine patches; in Switch Week 2, participants will use placebo patches.

Participants will be given Juul e-cigarettes for four weeks; in Switch Week 1, participants also will use placebo patches; in Switch Week 2, participants will use active nicotine patches.

Participants will be given very low nicotine cigarettes (VLNCs) for four weeks; in Switch Week 1, participants also will use active nicotine patches; in Switch Week 2, participants will use placebo patches.

The registry classes the interventions as device, drug and other.

More on the Plan

In addition, the investigators will explore the contexts in which participants are and are not able to switch from their conventional cigarettes.

Such contextual information will provide insight into internal (i.e., withdrawal, expectancies) and external environments (i.e., being around smokers, smoking restrictions) that promote or interfere with switching behavior.

The investigators will also explore person factors and beliefs that may drive alternative product use and substitution success.

Person factors that may influence use behavior include sex (a key biological variable), education level, dependence, instrumental smoking motives (e.g., smoking for affect regulation, taste, or social experiences), and psychiatric comorbidity.

Who Took Part

Enrollment: 209 actual participants took part.

It was open to people of any sex aged from 21 years with no upper age limit.

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

Examples of who could join: Smoking \>4 cigarettes/day for the previous 6 months. Able to read, write, and speak English. No plans to quit smoking in the next 30 days. Not currently taking smoking cessation medication. Willing and medically able to use nicotine patches.

The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: currently in treatment for psychosis or bipolar disorder; e-cigarette use within the last month; currently pregnant or breastfeeding.

How the Study Was Run

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

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

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

It started in 2020-09-09 with completion listed for 2022-05-23.

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

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Mean Number of Conventional Cigarettes Smoked During Each Switch Week (time frame: During the two 1-week switching periods).

It also tracked 1 secondary outcome, for example Mean Number of VLNCs Smoked or Vape Events Per Day Reported During Each Switch Week.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 209 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.