Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
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 we utilize focus groups and pilot testing with 15 youths to develop the behavioral activation smoking treatment for youth. In Phase II, we 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. Participants will be followed over 26 weeks post-quit date. A subset of participants will also undergo an fMRI session to examine reward sensitivity.

Detailed Description
-----------------
18-21 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

Official Title
-----------------
Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Drug: Transdermal Nicotine Patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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 a history of significant medical condition (e.g., cardiovascular , neurological, gastrointestinal), pregnancy and/or breast feeding, or other systemic illness limited mental competency [Mini Mental State Examination score < 23] and/or the inability to give informed, voluntary, written consent to participate current use of any pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt Additional Exclusion criteria only for the fMRI portion: cerebrovascular disease high blood pressure diabetes use of psychotropic medications in 3 weeks prior to participation in fMRI protocol exposure to extreme trauma lifetime history of mania, psychosis, or pervasive developmental disorder, being ambidextrous or left handed any metal implants, heart pacemaker, permanent retainer tattoos containing metal dyes claustrophobia.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Activation for Smoking<br>Eight 60-minute group sessions over an eight-week period. Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after treatment sessions have ended. Transdermal Nicotine: Participants will use 8 weeks of the nicotine patch at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to participant's initial nicotine level. | Drug: Transdermal Nicotine Patch<br>* Transdermal Nicotine: Participants will use 8 weeks of the nicotine patch at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to participant's initial nicotine level.<br>* Other names: Nicoderm CQ;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Smoking-Abstinent for 7 Days, 12 Weeks Post Quit Date | 7 days of smoking abstinence confirmed via expired carbon monoxide at 12 weeks | 12 weeks post quit date | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Behavioral Activation