Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry

NCT00968513 | Completed Results DMC

• 2 other identifiers: R01MH083684DAHBR A2-AID
• Study Type: interventional
• Target: 956
• Locations: 1 country
• Sites: 3

Brief Summary

This study aims to evaluate, in a randomized controlled trial, tobacco treatments of varying intensities for smokers hospitalized on acute psychiatric inpatient units.

Conditions

Tobacco Dependence

Keywords

Smoking Cessation, Inpatient Psychiatry, Stages of Change

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months

  Number of Participants who Quit Smoking at 3, 6, 12, and 18 Months

  3, 6, 12, and 18 Month Follow-up

• Commitment to Abstinence

  Changes from one assessment point to the next in a Likert scale (1 to 10) measure of desire to quit smoking. 10 = strongest desire to quit.

  baseline, 3, 6, 12, and 18 months

• Number of Participants With Quit Attempts Lasting 24 Hours or More

  Number of participants with quit attempts lasting 24 hours or more at each follow up timepoint.

  3, 6, 12, and 18 months follow-up

Study Arms (3)

Usual Care

ACTIVE COMPARATOR

(N=132) brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization

Behavioral: Usual Care

Brief Treatment

EXPERIMENTAL

(N=416) adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization.

Behavioral: Brief Intervention

Extended Treatment

EXPERIMENTAL

(N=408) builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment.

Behavioral: Extended Treatment

Interventions

Brief Intervention BEHAVIORAL

(N=416) adds a stage-based manual, computer-delivered stage-tailored individualized feedback and brief cessation counseling sessions during hospitalization and repeated at months 3 and 6, and access to 12 weeks of nicotine replacement following hospitalization

Brief Treatment

Extended Treatment BEHAVIORAL

(N=408) builds upon our current brief treatment and provides 12 additional weeks of nicotine replacement (24 weeks total) with individualized, counselor-delivered motivational and manualized cognitive behavioral cessation treatment.

Extended Treatment

Usual Care BEHAVIORAL

(N=132) brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Alta Bates Summit Medical Center

Berkeley, California, 94704, United States

Location

UCSF Langley Porter Psychiatric Institute

San Francisco, California, 94143, United States

Location

Stanford Hospital and Clinics

Stanford, California, 94304, United States

Location

Related Publications (3)

• Prochaska JJ, Grana RA. E-cigarette use among smokers with serious mental illness. PLoS One. 2014 Nov 24;9(11):e113013. doi: 10.1371/journal.pone.0113013. eCollection 2014.

  PMID: 25419703 DERIVED

• Schuck RK, Dahl A, Hall SM, Delucchi K, Fromont SC, Hall SE, Bonas T, Prochaska JJ. Smokers with serious mental illness and requests for nicotine replacement therapy post-hospitalisation. Tob Control. 2016 Jan;25(1):27-32. doi: 10.1136/tobaccocontrol-2014-051712. Epub 2014 Sep 10.

  PMID: 25209524 DERIVED

• Prochaska JJ, Fromont SC, Delucchi K, Young-Wolff KC, Benowitz NL, Hall S, Bonas T, Hall SM. Multiple risk-behavior profiles of smokers with serious mental illness and motivation for change. Health Psychol. 2014 Dec;33(12):1518-29. doi: 10.1037/a0035164. Epub 2014 Jan 27.

  PMID: 24467257 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Judith Prochaska
• Organization: Stanford University

jodi.prochaska@stanford.edu

6507243608

Study Officials

• Judith J. Prochaska, PhD, MPH

  Stanford University

  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 in Residence

Model Details: NRT

Study Record Dates

• First Submitted: August 28, 2009
• First Posted: August 31, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 11, 2025
• Results First Posted: June 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)