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Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation

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ClinicalTrials.gov Identifier: NCT01351766
Recruitment Status : Unknown
Verified June 2011 by University of Maryland.
Recruitment status was:  Recruiting
First Posted : May 11, 2011
Last Update Posted : June 13, 2011
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by:
University of Maryland

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Drug: Transdermal Nicotine Patch Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation
Study Start Date : April 2010
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Behavioral Activation Treatment for Smoking
BATSY includes standard smoking cessation strategies and identifying life areas, values, and daily activities to help manage mood. Participants will complete between group exercises and will also monitor and plan daily activities in line with their values. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period.
Drug: Transdermal Nicotine Patch
8 weeks of the Transdermal Nicotine Patch Nicoderm CQ 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.




Primary Outcome Measures :
  1. Smoking abstinence based on expired carbon monoxide tests, urinary cotinine tests, and self report [ Time Frame: 12 months post quit date ]


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Ages Eligible for Study:   18 Years to 21 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351766


Contacts
Contact: Laura MacPherson, PhD 301-405-7895 lmacpherson@psyc.umd.edu

Locations
United States, Maryland
University of Maryland, College Park Recruiting
College Park, Maryland, United States, 20742
Contact: Laura MacPherson, PhD    301-405-7895    lmacpherson@psyc.umd.edu   
Sponsors and Collaborators
University of Maryland
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Laura MacPherson, PhD University of Maryland

Responsible Party: Dr. Laura MacPherson, University of Maryland
ClinicalTrials.gov Identifier: NCT01351766     History of Changes
Other Study ID Numbers: DA029445
First Posted: May 11, 2011    Key Record Dates
Last Update Posted: June 13, 2011
Last Verified: June 2011

Keywords provided by University of Maryland:
Behavioral Activation

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action