Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry

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

Study Overview

• Status: Unknown
• Conditions: Tobacco Dependence
• Intervention / Treatment: Behavioral: Usual Care; Behavioral: Brief Intervention; Behavioral: Extended Treatment

Detailed Description

Using a three group additive design, this randomized clinical trial (N=1100) aims to evaluate tobacco cessation treatments of varying intensities initiated in the acute psychiatric inpatient setting. The three groups are:

1. Usual Care (N=150) consisting of brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization;
2. Brief Treatment (N=475) 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;
3. Extended Treatment (N=475) 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.

This study seeks to determine: (i) whether the initial successes seen in an academic-based psychiatric hospital can be replicated in a larger and more diverse patient population; and (ii) if more extended and intensive treatment combining nicotine replacement therapy (NRT) with individualized, counselor-delivered motivational and manualized cessation-focused cognitive behavioral counseling (CBT) can outperform our current best practices. Ultimately, this research could lead to a model smoking cessation intervention for smokers with severe mental illness and, more generally, may provide a useful model for understanding the nature and complexity of intervening on comorbidities.

We hypothesize that the extended treatment will outperform the brief treatment, and that both treatment groups will be more effective than usual care in producing quit attempts and ultimately abstinence from cigarettes. Secondary specific aims will model the cost-effectiveness and budgetary impacts of the treatment conditions; examine moderators and mediators of treatment outcomes; and prospectively examine the relation between changes in smoking, mental health functioning, and use of other substances over time.

• Study Type: Interventional
• Enrollment (Actual): 956
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94704
      • Alta Bates Summit Medical Center
    • San Francisco, California, United States, 94143
      • UCSF Langley Porter Psychiatric Institute
    • Stanford, California, United States, 94304
      • Stanford Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants (N=1100) will be men and women 18 years of age and older, recruited from four acute inpatient psychiatry units at the Alta Bates Summit Medical Center - Herrick Campus, located in Berkeley, CA, one acute inpatient psychiatry unit at Langley Porter Psychiatric Institute, located in San Francisco, CA, and two acute inpatient psychiatry units at Stanford Hospital, located in Stanford, CA. Inclusion criteria are: smoking 5 or more cigarettes per day and at least 100 cigarettes in one's lifetime, no plan to relocate outside of the greater Bay Area in the next 18 months, and telephone access for scheduling follow-up assessments.

Exclusion Criteria:

• Study exclusion criteria are: dementia or other brain injury precluding ability to participate; non-English speaking; complete homelessness; pregnancy or breastfeeding, and active ulcer disease (PUD). The relationship between nicotine and ulcers is a theoretical concern and our approach to now exclude patients with active ulcer disease is conservative. There is no data to show NRT causes/worsens ulcers. Recruitment of acutely psychotic, manic, or hostile patients will be delayed until there is significant reduction of these symptoms and patients are able to consent to study participation. Threats of violence in particular are taken seriously, and patients will not be recruited if they may be a threat to study staff in the outpatient setting. At this point, non-English measurement and intervention materials are not available. Pregnant smokers will be referred out for more specialized behavioral treatments. Exclusionary criteria are purposefully minimal in order to maximize information about treating tobacco dependence in smokers in inpatient psychiatry. The study sample is anticipated to be diverse with respect to gender and ethnicity, educational and socioeconomic level, and psychiatric diagnoses.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; (N=150) brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization	Behavioral: Usual Care; brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization
Experimental: Brief Treatment; (N=475) 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; (N=475) 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
Experimental: Extended Treatment; (N=475) 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; (N=475) 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
smoking status	baseline, 3, 6, 12, and 18 months follow-up
commitment to abstinence	baseline, 3, 6, 12, and 18 months
quit attempts	3, 6, 12, and 18 months follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
cost-effectiveness of the extended treatment in terms of cost per expected gain in life year compared to the brief treatment and usual care condition	3, 6, 12, and 18 months
Budget Impact Analysis on the incremental cost of adopting the extended and brief smoking cessation treatments in inpatient facilities calculated as a cost per treated person	3, 6, 12, and 18 months follow-up
change in psychiatric symptoms and alcohol and illicit drug use	baseline, 3, 6, 12, and 18 months follow-up

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Judith J. Prochaska, PhD, MPH, Stanford University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): June 1, 2015
• Study Completion (Anticipated): November 1, 2015

Study Registration Dates

• First Submitted: August 28, 2009
• First Submitted That Met QC Criteria: August 28, 2009
• First Posted (Estimate): August 31, 2009

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 19, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Smoking Cessation, Inpatient Psychiatry, Stages of Change
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: R01MH083684 (U.S. NIH Grant/Contract); DAHBR A2-AID (National Institute of Mental Health)