Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Treating Tobacco Dependence in Inpatient Psychiatry - 1

This study has been completed.
National Institute on Drug Abuse (NIDA)
University of California, San Francisco
Information provided by (Responsible Party):
Judith Prochaska, Stanford University Identifier:
First received: August 25, 2005
Last updated: April 23, 2016
Last verified: April 2016
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 Intervention Phase
Tobacco Use Cessation
Tobacco Use Disorder
Behavioral: stage-tailored intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treating Tobacco Dependence in Inpatient Psychiatry

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 7 Day Point Prevalence of Cigarette Abstinence [ Time Frame: 3 mo, 6 mo, 12 mo, and 18 mo post-baseline ] [ Designated as safety issue: No ]

Enrollment: 224
Study Start Date: July 2006
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00136812

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
Principal Investigator: Judith Prochaska University of California, San Francisco
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Judith Prochaska, Associate Professor, Stanford University Identifier: NCT00136812     History of Changes
Other Study ID Numbers: NIDA-18691-1  5K23DA018691-05 
Study First Received: August 25, 2005
Results First Received: February 22, 2016
Last Updated: April 23, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No
Plan Description: no plan to make individual participant data available

Keywords provided by Stanford University:

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders processed this record on October 26, 2016