Treating Tobacco Dependence in Inpatient Psychiatry - 1

Tobacco Use Disorder Clinical Trial

Official title:

Treating Tobacco Dependence in Inpatient Psychiatry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136812
• Other study ID #: NIDA-18691-1
• Secondary ID: 5K23DA018691-05
• Status: Completed
• Phase: N/A
• Start date: July 2006
• Est. completion date: April 2011

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tobacco Use Cessation
• Tobacco Use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Langley Porter Psychiatric Institute	San Francisco	California
United States	San Francisco General Hospital	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	National Institute on Drug Abuse (NIDA), University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (1)

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/J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7 Day Point Prevalence of Cigarette Abstinence		3 mo, 6 mo, 12 mo, and 18 mo post-baseline