The Long-Term Quitting (Smoking Cessation) Study

What Was Tested

The trial (phase 4) is built around Therapeutic nicotine (patch, non-peptide).

This study utilizes a sequential, multiple assignment, randomized trial (SMART) design - - an innovative multi-phase approach - - to test post-relapse treatments designed to assist smokers to make a new, successful quit attempt.

This study will test Relapse Recovery (RR) treatments that are applied at two stages following relapse: 1) RR Preparation Phase treatments for smokers who relapse after an initial quit attempt, and 2) RR Cessation Phase treatments for relapsed smokers who decide to make a new quit attempt.

It had nine arms (groups): one (active comparator), one (active comparator), one (active comparator), one (active comparator) and Recycling/Supportive+Skill Counseling (active comparator).

The registry classes the interventions as behavioral and drug.

More on the Plan

The study will use a sequential, multiple assignment, randomized trial (SMART) design with three phases.

In a SMART design, randomization occurs at more than one stage, with randomization at a later stage based on response to treatment at an earlier stage.

The three phases in this SMART study are as follows: 1.

Phase 1 consists of the Quit Phase in which all participants (smokers motivated to quit smoking) will be offered evidence-based cessation treatment (cessation medication plus counseling).

Who Took Part

1154 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: Age \>=18 years,. Smoking \>4 cigarettes/day for the previous 6 months,. Able to read, write, and speak English,. Have reliable phone access and agree to respond to Interactive Voice Response (IVR) phone prompts, and. Motivation to quit smoking, and.

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: currently taking bupropion or varenicline,; unwillingness to cease other forms of nicotine replacement or chantix (also called varenicline),; diagnosis of or treatment for schizophrenia, a psychotic disorder or bipolar disorder in the last 10 years and,.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

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

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

It started in 2015-10-30 with completion listed for 2019-11-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Biochemically-confirmed 7-Day Point Prevalence Abstinence (time frame: 14 Months after randomization to Phase 2 Preparation treatment).

It also tracked 1 secondary outcome, for example Self-Reported 7-Day Point Prevalence Abstinence.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 1154 people.

With 1154 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.