Clinical trial NCT00968513: Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry
Official title: Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: Smoking Cessation, Inpatient Psychiatry, Stages of Change
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-08-31
Enrollment: 956
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: NRT
Primary purpose: TREATMENT

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.

Detailed description: Using a three group additive design, this randomized clinical trial (N=956) aims to evaluate tobacco cessation treatments of varying intensities initiated in the acute psychiatric inpatient setting. The three groups are:

1. Usual Care (N=132) consisting of brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization;
2. Brief Treatment (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;
3. Extended Treatment (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.

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.

Eligibility criteria: Inclusion Criteria:

* Participants 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.

Primary outcomes:
measure: Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months
timeFrame: 3, 6, 12, and 18 Month Follow-up
measure: Commitment to Abstinence
timeFrame: baseline, 3, 6, 12, and 18 months
measure: Number of Participants With Quit Attempts Lasting 24 Hours or More
timeFrame: 3, 6, 12, and 18 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF Langley Porter Psychiatric Institute
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
affiliation: Stanford University
name: Judith J. Prochaska, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.