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Text Messaging for Smoking Cessation in College Health Clinics
Plain-language guide to NCT02191033: not phased randomized trial of Therapeutic nicotine (patch, non-peptide), 40 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02191033
- Phase
- not phased
- Status
- completed
- Start
- 2015-01
- Completion (planned or actual)
- 2016-05
- Participants
- 40 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Cigarette Smoking
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).
The primary hypothesis is that smokers receiving physician brief advice, nicotine replacement therapy, and text messaging will have higher quit rates that smokers receiving physician brief advice and nicotine replacement therapy alone.
It had two arms (groups): Text messaging (experimental) and Standard of care (active comparator).
Smoking counseling, nicotine patch, text messaging.
Smoking counseling, nicotine patch.
The registry classes the interventions as behavioral and drug.
Who Took Part
40 actual participants took part.
It was open to people of any sex aged from 18 years up to 24 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Aged 18 through 24 years. Enrolled as a full/part time college student. A current smoker (Have smoked more than 100 cigarettes in their lifetime and now smoke every day or some days). Interested in quitting. Have a cell phone for personal use with an unlimited text messaging plan.
The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: history of hypersensitivity/allergy to nicotine patch;; serious arrhythmias - history of heart disease (myocardial infarction, severe chest pain, or coronary artery disease); current pregnancy/breastfeeding/plan for pregnancy.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.
It started in 2015-01 with completion listed for 2016-05.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Study Enrollment- Number of Participants Who Join the Study (time frame: baseline). Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits (time frame: 6- and 12- weeks).
It also tracked 1 secondary outcome, for example Smoking Abstinence.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 40 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.