Behavioral Activation Therapy and Nicotine Replacement Therapy in Increasing Smoking Cessation

What Was Tested

The trial (not phased) is built around Therapeutic nicotine (patch, non-peptide).

Behavioral interventions use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction.

Giving behavioral activation therapy and nicotine replacement therapy may help patients quit smoking or change their smoking behavior.

It had two arms (groups): Group I (NRT, SC) (active comparator) and Group II (NRT, BATS) (active comparator).

Patients receive NRT patch daily for 8 weeks. Patients receive individual behavioral treatment sessions consisting of behavioral treatment strategies for smoking cessation and health education information over 45 minutes for 8 sessions.

Patients receive NRT patch daily for 8 weeks. Patients complete individual treatment sessions consisting of SC strategies and BA strategies over 45 minutes for 8 sessions.

The registry classes the interventions as behavioral, drug and other.

More on the Plan

To identify mediators of the BATS plus NRT treatment effect in IRS- smokers.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (STANDARD CESSATION): Patients receive NRT patch daily for 8 weeks.

Patients receive individual behavioral treatment sessions consisting of behavioral treatment strategies for smoking cessation and health education information over 45 minutes for 8 sessions.

Who Took Part

Enrollment: 85 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Interested in treatment that might change smoking behavior. Able to follow verbal and written instructions in English and complete all aspects of the study. Provide informed consent and agree to all assessments and study procedures. Have an address and telephone number where they may be reached. Be the only participant in their household.

The full record lists 6 inclusion and 22 exclusion criteria; among the exclusions: current enrollment or plans to enroll in another smoking cessation program in the next 6 months; plan to use other nicotine substitutes (i.e., over-the-counter \[otc\] or prescription medication for smoking cessation) or smoking cessation treatments in the next 6 months; uncontrolled hypertension (systolic blood pressure \[sbp\] greater than 180 or diastolic blood pressure \[dbp\] greater than 110).

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Therapeutic nicotine (patch, non-peptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2016-08-05 with completion listed for 2027-12-31.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Mediators of the behavioral activation treatment for smoking plus nicotine replacement therapy treatment effect in low reward sensitivity- smokers (time frame: Up to 4 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 85 people.

Its status is active not recruiting; 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.