← Human Trials & Peer-Reviewed Studies
Tobacco Treatment Comparison for Cancer Care
Plain-language guide to NCT06218823: phase 4 randomized trial of Therapeutic nicotine (patch, non-peptide), 52 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06218823
- Phase
- phase 4
- Status
- completed
- Start
- 2024-03-01
- Completion (planned or actual)
- 2025-08-04
- Participants
- 52 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Smoking Cessation; Cancer
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Therapeutic nicotine (patch, non-peptide).
Approximately 50 participants will be recruited to generate estimates of the effects, acceptability, costs, and equity of enhanced treatment (vs. standard treatment), with the primary outcome being abstinence from smoking 26 weeks after trying to quit.
It had two arms (groups): Low-Intensity Standard Smoking Cessation Treatment (active comparator) and one (experimental).
The registry classes the interventions as behavioral, drug and other.
Who Took Part
52 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: Alive (per medical record). Received care from a participating oncology clinic in the past year. Has a current tobacco use status. Does not have a preferred language other than English (missing language preference will be included). Valid address that is not a correctional facility or residential treatment/care facility.
The full record lists 12 inclusion and 5 exclusion criteria; among the exclusions: no current suicidal ideation; suicide attempt in the past year; currently receiving treatment for bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.
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 2024-03-01 with completion listed for 2025-08-04.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Biochemically Verified 7-day Point-prevalence Abstinence 26 Weeks After a Target Quit Date (time frame: up to 30 weeks post target quit date).
It also tracked 1 secondary outcome, for example Self-reported 7-day Point-prevalence Abstinence 12 Weeks After a Target Quit Date.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 52 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.
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.