Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry

Trial ID: NCT00968513

Purpose

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

Official Title

Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry

Stanford Investigator(s)

Judith Prochaska

Senior Associate Vice Provost, Clinical Research Governance and Professor of Medicine (Stanford Prevention Research Center)

Eligibility


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.

Intervention(s):

behavioral: Brief Intervention

behavioral: Extended Treatment

behavioral: Usual Care

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305