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Treating Tobacco Dependence in Adolescents With Co-occurring Psychiatric Disorders

Treating Tobacco Dependence in Adolescents With Co-occurring Psychiatric Disorders

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00618943
Enrollment
60
Registered
2008-02-20
Start date
2008-04-30
Completion date
2010-04-30
Last updated
2011-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use Cessation, Tobacco Use Disorder

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).

Interventions

BEHAVIORALTobacco 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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
7 day point prevalence of cigarette abstinence3, 6, 12 months post baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026