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Treating Tobacco Dependence in Adolescents With Co-Occurring Psychiatric Disorders
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), October 2008
Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00618943
  Purpose

This research aims to identify efficacious strategies for treating tobacco dependence among adolescent smokers with co-occurring psychiatric disorders. Adolescent smoking remains a significant public health issue with 23% of high school students reporting smoking a cigarette in the past month1. Smoking rates are two to four times higher among adolescents with psychiatric disorders such as attention deficit disorders, conduct disorder, depression, anxiety disorders, and alcohol and illicit drug dependencies2-4.

Empirical investigations of adolescent tobacco treatment interventions number less than 50 with many of the studies criticized for methodological problems (i.e., follow up < 6 months, poor retention, lack of control or comparison groups)2,5, 6. There have been no unequivocal successes; however, promising interventions include stage-based, cognitive behavioral (CBT), and multicomponent treatments2, 7. Additionally, the nicotine patch is well tolerated and safe among adolescents8 and rarely abused9. Less than a third of adolescent tobacco users report intention to quit in the near future2, 10, 11; thus, it seems critical that cessation interventions for this complex group be designed to assist smokers at all stages of readiness through the quitting process. A stepped care approach has the potential of matching more intensive services to those ready for and in need of greater treatment. Interventions delivered in health care settings have the appeal of broad reach.

The primary specific aims of this research are to evaluate, in a randomized clinical trial (N=160), the efficacy of a stepped care intervention for treating smoking among adolescents recruited from outpatient psychiatry settings. To our knowledge, this would be the first study to examine outpatient psychiatry settings for treating tobacco dependence in adolescents. The stepped care intervention combines expert-system contacts, individual CBT sessions, and 12-weeks of nicotine replacement therapy (NRT).


Condition Intervention Phase
Tobacco Use Cessation
Tobacco Use Disorder
Behavioral: Tobacco Use Cessation
Phase III

MedlinePlus related topics: Child Mental Health Mental Health Smoking Smoking and Youth
Drug Information available for: Nicotine polacrilex Nicotine tartrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Treating Tobacco Dependence in Adolescents With Co-Occurring Psychiatric Disorders

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 7 day point prevalence of cigarette abstinence [ Time Frame: 3, 6, 12 months post baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: April 2008
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Tobacco Use Cessation
    The proposed intervention will proceed in three steps. Step 1, provided to all intervention participants, includes multimedia, stage-based, expert-system contacts at intake, 3- and 6-months follow-up supported with brief (15-min) motivational counseling sessions. Step 2, reserved for intervention participants interested in quitting, consists of 12-weeks of individual CBT sessions for smoking cessation. Step 3, a 12-week course of nicotine patch, will be offered to adolescents who enter the CBT Cessation Treatment, who do not have any medical contraindications, and who smoke an average of 5 cigarettes or more per day in the past month.
  Eligibility

Ages Eligible for Study:   13 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • receiving active outpatient psychiatric care
  • report smoking at least 1 cigarette in the previous 30 days and at least 100 cigarettes in their lifetime
  • Other inclusion criteria are: no plan to relocate outside of the greater San Francisco Bay Area in the next 12 months and telephone access for scheduling follow up assessments.

Exclusion Criteria:

  • cognitive impairment precluding ability to participate
  • non-English speaking
  • currently engaged in tobacco treatment
  • Recruitment of acutely psychotic, manic, or hostile patients will be delayed until there is significant reduction of these symptoms and patients are able to assent to study participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618943

Contacts
Contact: Judith J Prochaska, PhD, MPH (415) 476-7695 JProchaska@lppi.ucsf.edu

Locations
United States, California
UCSF Langley Porter Psychiatric Institute Recruiting
San Francisco, California, United States, 94114
Contact: Anayansi Lombardero     415-476-8336        
San Mateo County Mental Health Recruiting
San Mateo, California, United States, 94403
Contact: Anayansi Lombardero     415-476-8336        
Edgewood Center for Children and Families Recruiting
San Bruno, California, United States, 94066
Contact: Anayansi Lombardero     415-476-8336        
Sponsors and Collaborators
Investigators
Principal Investigator: Judith J Prochaska, PhD, MPH University of California, San Francisco
  More Information

Responsible Party: University of California, San Francisco, Department of Psychiatry ( Judith J. Prochaska, PhD, MPH )
Study ID Numbers: NIDA-09253, P50-DA09253
Study First Received: February 15, 2008
Last Updated: October 30, 2008
ClinicalTrials.gov Identifier: NCT00618943  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Nicotine polacrilex
Nicotine
Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009