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N/A N=956 Randomized Treatment

Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry

Tobacco Dependence

Enrolled (actual)
956
Serious AEs
75.6%
Results posted
Jun 2025
Primary outcome: Primary: Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months — 13; 70; 63; 15 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Brief Intervention (Behavioral); Extended Treatment (Behavioral); Usual Care (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Stanford University
Primary completion
Jun 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Who Quit Smoking at 3, 6, 12, and 18 Months
13; 70; 63; 15; 75; 78
PRIMARY
Commitment to Abstinence
5.83; 6.20; 5.85; 6.27; 7.44; 7.09
PRIMARY
Number of Participants With Quit Attempts Lasting 24 Hours or More
42; 181; 162; 40; 169; 149

Summary

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

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00968513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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