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Treating Tobacco Dependence in Inpatient Psychiatry - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00136812
First received: August 25, 2005
Last updated: April 25, 2011
Last verified: April 2011

August 25, 2005
April 25, 2011
July 2006
April 2011   (final data collection date for primary outcome measure)
7 day point prevalence of cigarette abstinence [ Time Frame: 1 week, 3 mo, 6 mo, 12 mo, and 18 mo post-baseline ] [ Designated as safety issue: No ]
7 day point prevalence of cigarette abstinence
Complete list of historical versions of study NCT00136812 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Treating Tobacco Dependence in Inpatient Psychiatry - 1
Treating Tobacco Dependence in Inpatient Psychiatry

The purpose of this study is to test in a randomized clinical trial (N=300) a series of hypotheses concerning the efficacy of an extended expert-system intervention plus nicotine replacement therapy (NRT) for treating tobacco dependence among patients hospitalized on a smoke-free psychiatric unit. It is hypothesized that the intervention will be more effective than the enhanced standard care control condition (on-unit NRT with self-help brochure) in producing biochemically verified abstinence from cigarettes at 3-, 6-, 12-, and 18-months follow up. Additionally, intervention participants will exhibit greater stage progression, commitment to abstinence, and delay in relapse to smoking following hospital discharge, factors predictive of future success with quitting smoking. Smoking cessation treatments have been shown to be highly cost-effective with the general population of smokers, and cost is likely to be a consideration in efforts to incorporate additional services into an inpatient psychiatric setting. Therefore, a secondary specific aim is to model the cost-effectiveness of the smoking cessation intervention. Intervention efficacy will be examined in a university-based psychiatric inpatient unit. A smaller pilot study (N=48) will examine translation of the intervention to a county hospital serving a more diversified patient population.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Tobacco Use Cessation
  • Tobacco Use Disorder
Behavioral: Tobacco Use Cessation
This intervention consists of nicotine patch therapy during hospitalization; a stage-based self-help manual; an individualized, expert-system, feedback report at intake, 3 months and 6 months post-hospitalization with carbon copies sent to participants' outpatient clinicians; and an individual 30-min smoking cessation counseling sessions during hospitalization. Additionally, up to 10 weeks of nicotine patch is provided to intervention participants intending to stay quit following hospital discharge.
  • No Intervention: 1
    enhanced standard care control
  • Experimental: 2
    intervention
    Intervention: Behavioral: Tobacco Use Cessation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Men and women over 18 years of age hospitalized on an inpatient psychiatric unit who report smoking at least 5 cigarettes per day. Other inclusion criteria include: smoking at least 100 cigarettes in one's lifetime, residing in the San Francisco Bay Area with no plan to relocate outside of the area in the next 18 months, and access to a telephone for scheduling follow up assessments.

Exclusion Criteria:

Dementia or other brain injury precluding ability to participate; non-English speaking; severe agitation, psychosis, or hostility; and medical contraindications to nicotine replacement therapy (NRT). Recruitment of acutely psychotic, manic, or hostile patients will be delayed until there is significant reduction of these symptoms. Medical contraindications are: myocardial infarction in the preceding 3 months, unstable angina pectoris, liver or kidney disease, current pregnancy or breast feeding, allergies to adhesives, or other medical conditions that the medical team deems incompatible with NRT use.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00136812
NIDA-18691-1, 5K23DA018691-05, K23-18691-1
Not Provided
Judith Prochaska, PhD, MPH / Assistant Professor, UCSF
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Principal Investigator: Judith Prochaska University of California, San Francisco
University of California, San Francisco
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP