Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry
Trial ID or NCT#
NCT00968513
Status
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Investigator(s)
Judith Prochaska
Senior Associate Vice Provost, Clinical Research Governance and Professor of Medicine (Stanford Prevention Research Center)
View on ClinicalTrials.gov
