Smoking Cessation for Veterans With Severe and Persistent Mental Illness

Smoking is the leading cause of preventable death in the United States. Smoking contributes
to increased rates of diseases such as lung cancer and heart disease, and adds dangerous
complications to health problems such as diabetes and obesity. Despite widespread
recognition of the devastating health effects of smoking, over 70% of people with
schizophrenia and other serious and persistent mental illnesses (SPMI) smoke cigarettes, a
rate that is at least double that of the general population and remains high despite
decreases in rates of smoking in the general population. These extraordinary smoking rates
contribute to elevated morbidity and mortality, have other life-threatening health-related
consequences, and increase health care costs for treating smoking related illnesses in this
population. Treating smoking is critical in improving the health of people with SPMI.

The newly revised VA/Department of Defense Clinical Practice Guideline for the Management of
Tobacco Use outlines the VHA's comprehensive program for smoking cessation. Beginning in
1997, the VA central office directed that the Agency for Health Care Policy and Research
(AHCPR) smoking cessation guideline (the 5 A's - Ask, Advise, Assess, Assist, Arrange) be
implemented in all its health care facilities. Reinforcing their commitment to increasing
veterans' access to evidence-based smoking cessation interventions, the VHA recently
released a new policy mandating that smoking cessation treatment be made available without
restriction at all VA sites. Our previous study implementing the 5A's in community mental
health clinics has found reduced smoking and increased use of smoking cessation aids such as
nicotine replacement therapy (NRT), but no only modest increases in abstinence.
Implementation of the 5 A's was limited by inability to adequately assist patients to stop
smoking. Consideration of how best to supplement the "Assist" and "Arrange" phases reveals
the troubling observation that existing "best practice" treatments for smoking cessation
have limited effectiveness for persons with SPMI. The most widely tested treatments consist
generally of adaptations of American Lung Association (ALA) or comparable 10-14 session
weekly groups supplemented by either nicotine replacement therapy (NRT) or Bupropion. Such
programs produce low abstinence rates (0-25%) at end of intervention. Sustained abstinence
is virtually non-existent. Abstinence at 6-month or 1-year follow-up points ranges from
0-10%.

We have developed an intervention the treatment of cocaine and heroin use disorders among
persons with SPMI, called Behavioral Treatment for Substance Abuse in Serious and Persistent
Mental Illness (BTSAS). BTSAS was developed with a series of National Institute on Drug
Abuse (NIDA-funded treatment development grants as a treatment program for substance abuse
that accommodated the cognitive and motivational impairments that characterize SPMI. The
goal was to incorporate strategies that have been found to be effective in reducing drug use
more generally, but to tailor them to meet the needs of people with SPMI. BTSAS provides a
model for this application's test of an innovative smoking cessation treatment. Our basic
premise is that we must first acknowledge nicotine dependence as an addiction with
characteristics common to other substance addictions, and then specify the additional
biological, social, cognitive, psychological and environmental barriers to quitting smoking
for people with SPMI. We must then fully optimize available technologies for addiction in
general and smoking cessation in particular to address these deficits. Existing approaches
to smoking cessation for persons with SPMI do not use the full range of biological,
contingency management, social modeling and behavioral tools that have been shown to work in
treating other addictions in this population. Further, research on treatment of substance
use disorders in persons with SPMI has suggested that, for best outcomes, interventions may
need to be more intensive that what is provided for other groups of substance abusers.
Applied to smoking, this suggests that for people with SPMI, smoking cessation may need to
be more intensive than the 9 weekly sessions typical of conventional smoking cessation
programs.

Based on our work developing BTSAS, and the above features of smoking in SPMI, we have
developed an intervention called Behavioral Treatment of Smoking Cessation in SPMI (BTSCS),
an innovative intervention that supplements pharmacotherapy and education with breath carbon
monoxide monitoring and a multifaceted behavioral group treatment program that lasts for
three months (24 sessions). BTSCS is designed to address the cognitive, motivational, and
social support problems characteristic of people with SPMI. We propose to conduct a
randomized clinical trial comparing BTSCS to a standard smoking cessation treatment.

Specific Aims: To determine if BTSCS is more effective in producing abstinence from smoking
than a manualized smoking cessation program that reflects current best practices (StSST).

Hypothesis 1: BTSCS will result in greater rates of abstinence than StSST as shown by:

1. A higher percentage of negative expired carbon monoxide levels at biweekly treatment
sessions

2. Increased days of abstinence reported at biweekly treatment sessions

3. A higher percentage of negative expired carbon monoxide levels immediately
post-treatment.

4. A higher percentage of participants reporting abstinence in the 7-day interval
preceding the post-treatment assessment.

Secondary Aims: We will assess the effectiveness of BTSCS on a set of intermediate outcomes
including a reduction in smoking severity and improvement in readiness to quit smoking among
smokers who have not been able to quit. We will also assess if increased treatment
attendance and use of NRT's and bupropion moderate the hypothesized increases in abstinence.

Inclusion Criteria:

- DSM-IV diagnosis of severe and persistent mental illness (SPMI) including a diagnosis
of a psychotic disorder in keeping with criteria established by the Serious Mental
Illness Treatment Research and Evaluation Center (SMITREC) -Schizophrenic disorders,
affective psychoses and other psychotic diagnoses. We also include individuals with a
diagnosis of Major Depression with psychotic features and PTSD.

- Age 18-75

- Nicotine dependence as defined by a score of 5 or higher on the Fagerstrom Tolerance
Scale OR Participants who currently smoke at least 10 cigarettes per day

- Participants will not meet criteria for current alcohol/substance dependence (other
than nicotine)

- Willingness ability to provide consent to participate.

Exclusion Criteria:

- Documented history of severe neurological disorder or severe head trauma with loss of
consciousness

- Severe or profound mental retardation by chart review.