Treating Tobacco Dependence in Adolescents With Co-occurring Psychiatric Disorders
2 other identifiers
interventional
60
1 country
3
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2008
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2008
CompletedFirst Posted
Study publicly available on registry
February 20, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedDecember 8, 2011
December 1, 2011
2 years
February 15, 2008
December 7, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
7 day point prevalence of cigarette abstinence
3, 6, 12 months post baseline
Interventions
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 Criteria
You may qualify if:
- receiving active outpatient psychiatric care
- report smoking at least 1 cigarette in the previous 30 days and at least 100 cigarettes in their lifetime
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Edgewood Center for Children and Families
San Bruno, California, 94066, United States
UCSF Langley Porter Psychiatric Institute
San Francisco, California, 94114, United States
San Mateo County Mental Health
San Mateo, California, 94403, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Judith J Prochaska, PhD, MPH
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor in Residence
Study Record Dates
First Submitted
February 15, 2008
First Posted
February 20, 2008
Study Start
April 1, 2008
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
December 8, 2011
Record last verified: 2011-12