NCT00136812

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
10 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
5 years until next milestone

Results Posted

Study results publicly available

March 23, 2016

Completed
Last Updated

April 11, 2024

Status Verified

March 1, 2024

Enrollment Period

4.8 years

First QC Date

August 25, 2005

Results QC Date

February 22, 2016

Last Update Submit

March 15, 2024

Conditions

Keywords

tobacco

Outcome Measures

Primary Outcomes (1)

  • 7 Day Point Prevalence of Cigarette Abstinence

    3 mo, 6 mo, 12 mo, and 18 mo post-baseline

Study Arms (2)

enhanced usual care control

NO INTERVENTION

NRT during hospitalization with brief advice to stay quit once discharged

stage-tailored intervention

EXPERIMENTAL

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

Interventions

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.

stage-tailored intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Langley Porter Psychiatric Institute

San Francisco, California, 94143, United States

Location

Related 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/JCP.14m09016.

MeSH Terms

Conditions

Tobacco Use CessationTobacco Use Disorder

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Judith Prochaska, PhD, MPH; Associate Professor
Organization
Stanord University

Study Officials

  • Judith Prochaska

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

July 1, 2006

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 11, 2024

Results First Posted

March 23, 2016

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

no plan to make individual participant data available

Locations