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Plain-language guide to NCT05014282: not phased randomized trial of Therapeutic nicotine (patch, non-peptide), 512 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05014282
Phase
not phased
Status
active, not recruiting
Start
2021-12-15
Completion (planned or actual)
2025-09-23
Participants
512 (actual)
Design
randomized, open label (everyone knows who gets what), prevention
Conditions studied
Smoking Cessation
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

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

This study evaluates whether Automated Treatment performed better, in terms of facilitating long-term smoking abstinence, than the more resource-intensive Standard Treatment.

It had two arms (groups): Standard Treatment (active comparator) and Automated Treatment (experimental).

Participants randomized to Standard Treatment (ST) were provided with a 10-week supply of nicotine patches and lozenges. ST participants were connected with their state's Quitline services to receive smoking cessation treatment.

Participants randomized to Automated Treatment (AT) were given a 10-week supply of nicotine patches and lozenges. AT comprised: 1) 12 proactive video-based treatment sessions, delivered weekly, that were tailored on smoking status, motivation, agency, and negative affect/stress; 2) 26 weeks of on-demand access to treatment content tailored on smoking status, motivation, agency, and negative affect/stress; 3) 26 weeks of text content.

The registry classes the interventions as behavioral and drug.

Who Took Part

512 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: Smoked \>/=100 cigarettes in lifetime. English or Spanish speaking. Currently smoke \> 5 cigarettes/day. Willing to make a quit attempt within 1 week of enrollment. Process a smartphone compatible with the project app.

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: currently pregnant or breastfeeding; current use of smoking cessation medications; enrolled in a smoking cessation study.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

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

It started in 2021-12-15 with completion listed for 2025-09-23.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Self-Reported 7-Day Point-Prevalence Smoking Abstinence (time frame: 12 Month Follow-Up).

It also tracked 3 secondary outcomes, for example Biochemical Verification Via Salivary Cotinine, Self Reported 24 Hours Smoking Abstinence and Self-Reported 30-Day Point-Prevalence Smoking Abstinence.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 512 people.

With 512 participants it is a large trial for this field.

Its status is active not recruiting; 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.

Our Notes on the Compound

Therapeutic nicotine (patch, non-peptide): Pure nicotine as a signaling tool, separated from smoking and vaping.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.