Clinical trial NCT00618943: Treating Tobacco Dependence in Adolescents With Co-occurring Psychiatric Disorders
Official title: Treating Tobacco Dependence in Adolescents With Co-occurring Psychiatric Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tobacco Use Cessation
Tobacco Use Disorder
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: 7 day point prevalence of cigarette abstinence
timeFrame: 3, 6, 12 months post baseline
Secondary outcomes:
Other outcomes:
Locations:
city: San Bruno
country: United States
facility: Edgewood Center for Children and Families
state: California
city: San Francisco
country: United States
facility: UCSF Langley Porter Psychiatric Institute
state: California
city: San Mateo
country: United States
facility: San Mateo County Mental Health
state: California
Study officials:
affiliation: University of California, San Francisco
name: Judith J Prochaska, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: