Treating Tobacco Dependence in Inpatient Psychiatry - 1

Not Applicable

Completed

• Conditions: Tobacco Use Cessation; Tobacco Use Disorder
• Interventions: Behavioral: stage-tailored intervention

• Registration Number: NCT00136812
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-29
• Study Start: 2006-07
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2016-02-22
• Results First Submitted QC: 2016-02-22
• Results First Posted: 2016-03-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stage-tailored intervention	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

Primary Outcome Measures

Name	Time	Method
7 Day Point Prevalence of Cigarette Abstinence	3 mo, 6 mo, 12 mo, and 18 mo post-baseline

Trial Locations

Locations (2)

San Francisco General Hospital; 🇺🇸 San Francisco, California, United States

Langley Porter Psychiatric Institute; 🇺🇸 San Francisco, California, United States