Treating Tobacco Dependence in Adolescents With Co-occurring Psychiatric Disorders

Study Overview
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Brief Summary
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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).

Official Title
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Treating Tobacco Dependence in Adolescents With Co-occurring Psychiatric Disorders

Conditions
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Tobacco Use Cessation, Tobacco Use Disorder

Intervention / Treatment
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* Behavioral: Tobacco Use Cessation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7 day point prevalence of cigarette abstinence |  | 3, 6, 12 months post baseline |