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Coping Skills Treatment for Smoking Cessation

Plain-language guide to NCT01061528: not phased randomized trial of Therapeutic nicotine (patch, non-peptide), 116 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01061528
Phase
not phased
Status
completed
Start
2009-09
Completion (planned or actual)
2013-08
Participants
116 (actual)
Design
randomized, single-blind, treatment
Conditions studied
Nicotine Dependence
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

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

In both treatments, participants will receive one 60-minute individual session, seven 2-hour group sessions and two individual brief telephone contacts over an eight-week period.

Both treatments include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after the treatment sessions have ended.

It had two arms (groups): New Smoking Cessation Counseling (experimental) and Standard Smoking Cessation Counseling (active comparator).

The registry classes the interventions as drug.

More on the Plan

1. 18-65 years of age, 2. a regular smoker for at least one year, 3. currently smoking 10 or more cigarettes per day, 4. report motivation to quit smoking in the next month.

Who Took Part

Enrollment: 116 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: 18-65 years old. Regular smoker for at least one year. Currently smoking 10 or more cigarettes per day.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: current axis i disorder; current suicidal risk; pregnancy or breast feeding.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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.

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

In this single-blind Therapeutic nicotine (patch, non-peptide) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2009-09 with completion listed for 2013-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With Biochemically Verified Smoking Abstinence (time frame: Six months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 116 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.