We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov 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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Tobacco Use Disorder Behavioral: stage-tailored intervention Phase 2

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treating Tobacco Dependence in Inpatient Psychiatry
Study Start Date : July 2006
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Arm Intervention/treatment
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
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.

Primary Outcome Measures :
  1. 7 Day Point Prevalence of Cigarette Abstinence [ Time Frame: 3 mo, 6 mo, 12 mo, and 18 mo post-baseline ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136812

Layout table for location information
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Langley Porter Psychiatric Institute
San Francisco, California, United States, 94143
Sponsors and Collaborators
Stanford University
National Institute on Drug Abuse (NIDA)
University of California, San Francisco
Layout table for investigator information
Principal Investigator: Judith Prochaska University of California, San Francisco
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Judith Prochaska, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00136812    
Other Study ID Numbers: NIDA-18691-1
5K23DA018691-05 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2005    Key Record Dates
Results First Posted: March 23, 2016
Last Update Posted: May 25, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to make individual participant data available
Keywords provided by Judith Prochaska, Stanford University:
Additional relevant MeSH terms:
Layout table for MeSH terms
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders