CAN-DOSE Study: Cessation With Augmented Nicotine for Dual Use Of Smoking and E-cigarettes

What Was Tested

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

Many people smoke cigarettes and use e-cigarettes, and have a hard time stopping.

It had three arms (groups): Arm A (active comparator), Arm B (active comparator) and Arm C (active comparator).

The registry classes the interventions as drug.

More on the Plan

Alternative tobacco products have grown popular in the past decade, including electronic cigarettes (e-cigarettes; vaping).

E-cigarettes were initially marketed as an alternative to or means for smoking cessation and became popular amongst those currently smoking.

Despite this, there is a lack of empirically tested interventions for dual use cessation among the general adult population.

However, dual users (individuals who smoke cigarettes and use e-cigarettes) did not respond similarly.

Who Took Part

The registry lists 46 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18yrs +. Daily nicotine-containing e-cigarette user (25+ days per previous month). E-cigarette use 5+ times/day. E-cigarette use \> 1year. Smoking \>1 cigarette on 5-7 days per week.

The full record lists 9 inclusion and 4 exclusion criteria; among the exclusions: individuals reporting current use of other nicotine-containing products and/or smoking cessation medications; those who vape non-nicotine substances.

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.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-12-05 with completion listed for 2024-11-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Days of Dual Use Abstinence (time frame: Day 28, Day 56).

It also tracked 3 secondary outcomes, for example Safety (Adverse Events) and Feasibility/Acceptability.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 46 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.