Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry

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.

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.