DOSE-UP: Dose Optimization for Smoking and E-Cigarette Use Pharmacotherapy

What Was Tested

In this phase 2 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

All groups receive evidence-based behavioral support through the EX Program.

It had three arms (groups): Behavioral Support (active comparator), one (experimental) and one (experimental).

Participants will receive behavioral support only.

The registry classes the interventions as behavioral and drug.

Who Took Part

The registry lists 321 planned participants were the target.

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: Report nicotine-containing e-cigarette use 5+ times per day, \>5 days per week, for \> 6 months;. Smoking \>1 cigarette per day, \>5 days per week, for \>6 months;. Interest in quitting cigarettes and e-cigarettes within the next month (\>6 on 10-point scale);. Willing to try nicotine replacement therapy;. Access to text/internet/email.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: report use of other tobacco or nicotine products (i.e., pouches, smokeless tobacco, hookah) \>1 time per week in the past 3 months;; report current use of smoking cessation medications (varenicline, bupropion, other nicotine replacement therapies);; endorse symptoms of cannabis use disorder (using the cudit assessment);.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2026-11-01 with completion listed for 2030-04-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Dual use abstinence (time frame: Week 12, Week 24). Cigarette abstinence (time frame: Weeks 12, Week 24).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 321 people.

Its status is not yet recruiting; 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.