Treating Tobacco Dependence in Inpatient Psychiatry - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00136812
Recruitment Status : Completed
First Posted : August 29, 2005
Results First Posted : March 23, 2016
Last Update Posted : May 25, 2016
National Institute on Drug Abuse (NIDA)
University of California, San Francisco
Information provided by (Responsible Party):
Judith Prochaska, Stanford University

August 25, 2005
August 29, 2005
February 22, 2016
March 23, 2016
May 25, 2016
July 2006
April 2011   (Final data collection date for primary outcome measure)
7 Day Point Prevalence of Cigarette Abstinence [ Time Frame: 3 mo, 6 mo, 12 mo, and 18 mo post-baseline ]
7 Day Point Prevalence of Cigarette Abstinence
Complete list of historical versions of study NCT00136812 on Archive Site
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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 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 will examine translation of the intervention to a county hospital serving a more diversified patient population.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Tobacco Use Cessation
  • Tobacco Use Disorder
Behavioral: stage-tailored intervention
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: enhanced usual care control
    NRT during hospitalization with brief advice to stay quit once discharged
  • Experimental: stage-tailored intervention
    NRT during hospitalization with brief advice to stay quit once discharged plus a computer-delivered stage-tailored smoking cessation intervention with manual and counseling plus 10-weeks of nicotine patch available post-hospitalization
    Intervention: Behavioral: stage-tailored intervention
Barnett PG, Wong W, Jeffers A, Hall SM, Prochaska JJ. Cost-effectiveness of smoking cessation treatment initiated during psychiatric hospitalization: analysis from a randomized, controlled trial. J Clin Psychiatry. 2015 Oct;76(10):e1285-91. doi: 10.4088/JCP.14m09016.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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; 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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
5K23DA018691-05 ( U.S. NIH Grant/Contract )
Not Provided
Plan to Share IPD: No
Plan Description: no plan to make individual participant data available
Judith Prochaska, Stanford University
Stanford University
  • National Institute on Drug Abuse (NIDA)
  • University of California, San Francisco
Principal Investigator: Judith Prochaska University of California, San Francisco
Stanford University
April 2016

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