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Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University of Maryland.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT01351766
First received: May 9, 2011
Last updated: June 10, 2011
Last verified: June 2011
  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.


Condition Intervention Phase
Smoking
Drug: Transdermal Nicotine Patch
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Smoking abstinence based on expired carbon monoxide tests, urinary cotinine tests, and self report [ Time Frame: 12 months post quit date ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 21 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Laura MacPherson, PhD University of Maryland
  More Information

No publications provided

Responsible Party: Dr. Laura MacPherson, University of Maryland
ClinicalTrials.gov Identifier: NCT01351766     History of Changes
Other Study ID Numbers: DA029445
Study First Received: May 9, 2011
Last Updated: June 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Behavioral Activation

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

ClinicalTrials.gov processed this record on November 27, 2014