Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation

What Was Tested

In this phase 3 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

The primary purpose of this study is to develop a specialized behavioral activation treatment for smoking in youths ages 18-21 with elevated depressive symptoms.

In the first phase the researchers utilize focus groups and pilot testing with 15 youths to develop the behavioral activation smoking treatment for youth.

In Phase II, the researchers will conduct an open-label trial of the new treatment that will include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking.

It had 1 arm (groups): Behavioral Activation for Smoking (experimental).

The registry classes the interventions as drug.

More on the Plan

1. 18-21 years of age, 2. a regular smoker for at least 6 months 3. currently smoking an average of at least 5 cigarettes per day 4. want to quit smoking 5. report current elevated depressive symptoms.

Who Took Part

Enrollment: 39 actual participants took part.

It was open to people of any sex aged from 18 years up to 21 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Between 18 and 21 years of age. A regular smoker for at least 6 months. Currently smoking an average of at least 5 cigarettes per day. Want to quit smoking. Report current elevated depressive symptoms.

The full record lists 5 inclusion and 16 exclusion criteria; among the exclusions: current axis i disorder; psychoactive substance dependence (excluding nicotine dependence) within the past 6 months; current use of psychotropic medication or participation in any form of psychotherapy.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.

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

It started in 2010-04 with completion listed for 2013-05.

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 Smoking-Abstinent for 7 Days, 12 Weeks Post Quit Date (time frame: 12 weeks post quit date).

What This Means in Plain Language

Put simply, this is a phase 3 trial of Therapeutic nicotine (patch, non-peptide) in 39 people.

Its size is small, so on its own it can only give an early look.

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.