A Comparative Effectiveness RCT of Optimized Cessation Treatments

What Was Tested

In this phase 4 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

This study is a 2-arm randomized clinical trial (RCT).

Participants motivated to quit smoking will be randomized to one of two treatments: 1) a Modern Usual Care (M-UC) vs. 2) Abstinence-Optimized Cessation Treatment (AOCT).

The components for the optimized treatment have strong theoretical and empirical support from the investigators previous screening studies.

It had two arms (groups): Modern Usual Care (active comparator) and Abstinence-Optimized Cessation Treatment (experimental).

There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.

The registry classes the interventions as behavioral and drug.

More on the Plan

The ultimate goal of this research is to develop a chronic care treatment package for smokers that will address the challenges and opportunities of each phase of the cessation process - motivation, preparation, cessation, maintenance, and relapse recovery.

That is, to develop treatments for smokers not yet ready to quit, those who are preparing to quit, those actively engaged in the quitting process and those who have tried to quit but relapsed.

To achieve this goal, this research comprises three distinct research studies, each of which represent a phase in a comprehensive chronic care treatment model for clinical intervention with smokers in the primary care setting: the Motivation Study, the Cessation Study, and the Long-term Quitting Study.

Who Took Part

The registry lists 623 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 if currently using NRT, agreeing to use only study medication for the duration of the study.

The full record lists 9 inclusion and 4 exclusion criteria; among the exclusions: currently taking bupropion or varenicline; diagnosis of or treatment for schizophrenia, a psychotic disorder or bipolar disorder in the last 10 years.

How the Study Was Run

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

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.

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 2015-01 with completion listed for 2017-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Abstinence From Smoking (time frame: 6 months post treatment).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 623 people.

With 623 participants it is a large trial for this field.

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.