Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation

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City:		College Park
State:		Maryland
Zip Code:		20742

Conditions:		Smoking
Purpose:		Evidence suggests a significant percentage of adolescent regular smokers are interested in trying to quit smoking and frequently make attempts to quit, yet are unsuccessful in maintaining abstinence on their own. Despite a genuine desire to quit on the part of many adolescents, there is an increasing incidence of smoking among older adolescents that runs counter to the overall trends of smoking reduction seen in the general population. Unfortunately, psychosocial and pharmacological smoking interventions have yet to indicate clear effectiveness with youth. Moreover, depression-related vulnerabilities, particularly currently elevated depressive symptoms, are highly comorbid with smoking behavior and dramatically reduce cessation rates. As a result, new approaches to smoking cessation are needed for adolescent smokers with currently elevated depressive symptoms. Thus the objective of the present 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 (BATSY). In Phase II, we will conduct an open-label trial of BATSY plus nicotine replacement therapy with 30 youths who will also take part in a neuroimaging protocol examining reward sensitivity. Participants will be followed over 26 weeks post-quit date.
Study Summary:		This will be a Open-label trial to examine the efficacy of behavioral activation treatment for smoking-youths (BATSY). After completing a focus group phase and pilot study phase of BATSY with 15 youths, we will recruit 30 adolescent smokers with elevated depressive symptoms between the ages of 18-21 into the open-label trial of the the BATSY treatment. All participants in the open-label trial will receive 8 weeks of transdermal nicotine patch in addition to the BATSY intervention. Participants will also undergo an fMRI session including a behavioral task assessing reward sensitivity prior to commencement of the BATSY intervention. We intend to examine both abstinence and relapse outcomes. In addition we will examine to what extent depressive symptoms and reward sensitivity prior to quit date will correspond with improved smoking cessation outcomes over time.
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 fMRI Exclusion criteria: - 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.
NCT ID:		NCT01351766
Primary Contact:		Principal Investigator Laura MacPherson, PhD University of Maryland Laura MacPherson, PhD Phone: 301-405-7895 Email: lmacpherson@psyc.umd.edu
Backup Contact:		N/A
Location Contact:		College Park, Maryland 20742 United States Laura MacPherson, PhD Phone: 301-405-7895 Email: lmacpherson@psyc.umd.edu Site Status: Recruiting

Data Source:		ClinicalTrials.gov
Date Processed:		May 21, 2013
Modifications to this listing:		Only selected fields are shown, please use the link below to view all information about this clinical trial.
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