Treating Tobacco Dependence in Adolescents With Co-occurring Psychiatric Disorders
Primary Purpose
Tobacco Use Cessation, Tobacco Use Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tobacco Use Cessation
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Use Cessation
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
Sites / Locations
- Edgewood Center for Children and Families
- UCSF Langley Porter Psychiatric Institute
- San Mateo County Mental Health
Outcomes
Primary Outcome Measures
7 day point prevalence of cigarette abstinence
Secondary Outcome Measures
Full Information
NCT ID
NCT00618943
First Posted
February 15, 2008
Last Updated
December 7, 2011
Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00618943
Brief Title
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
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Cessation, Tobacco Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Tobacco Use Cessation
Intervention Description
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.
Primary Outcome Measure Information:
Title
7 day point prevalence of cigarette abstinence
Time Frame
3, 6, 12 months post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith J Prochaska, PhD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edgewood Center for Children and Families
City
San Bruno
State/Province
California
ZIP/Postal Code
94066
Country
United States
Facility Name
UCSF Langley Porter Psychiatric Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
San Mateo County Mental Health
City
San Mateo
State/Province
California
ZIP/Postal Code
94403
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treating Tobacco Dependence in Adolescents With Co-occurring Psychiatric Disorders
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