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Determinants of Smoking Cessation Among Latinos

Plain-language guide to NCT01008748: not phased interventional trial of Therapeutic nicotine (patch, non-peptide), 200 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01008748
Phase
not phased
Status
completed
Start
2009-09
Completion (planned or actual)
2016-09
Participants
200 (actual)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Smoking Cessation
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 goal of this study is to learn how neighborhood and individual factors affect the ability to stop smoking among Spanish-speaking Mexican American (MA) smokers who want to quit smoking.

It had 1 arm (groups): Smoking Cessation Treatment (experimental).

Nicotine replacement therapy (NRT), self-help materials, + brief in-person and telephone counseling, all conducted in Spanish. Computerized questionnaires at each of 5 visits and will take 1 1/2 hours to complete each time.

The registry classes the interventions as behavioral and drug.

More on the Plan

If you agree to take part in this study, you will receive treatment to help you quit smoking, including written self-help materials, counseling, and a supply of the nicotine patch for 4 weeks.

Over the next 6 months, you will visit M.

You will also be called 3 times for smoking cessation counseling during this study.

Study Visits: First (Orientation) Visit You will be asked about your feelings and moods, as well as how many cigarettes you smoke.

Who Took Part

Enrollment: 200 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Current daily smoker who average \>/= 5 cigarettes/day for the last year. Mexican-American (MA) Adults from the Houston-based MA Cohort Study and/or from the community. Age 18 to 65 years. Motivated to quit smoking in the next 30 days. Viable (working) telephone number and home address.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: contraindication for nicotine patch use; regular use of tobacco products other than cigarettes (cigars, pipes, smokeless tobacco); use of nicotine replacement therapy products or other smoking cessation medications, other than the nicotine patches supplied during the study.

How the Study Was Run

Design: single-group and open-label.

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2009-09 with completion listed for 2016-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants With 24-Hour Smoking Abstinence (Week 3 Post Quit Day) (time frame: Week 3 post quit day). 24-Hour Smoking Abstinence (Week 26 Post Quit Day) (time frame: Week 26 post quit day). 7-Day Smoking Abstinence (Week 3 Post Quit Day) (time frame: Week 3 post quit day).

What This Means in Plain Language

Put simply, this is a not phased trial of Therapeutic nicotine (patch, non-peptide) in 200 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.