Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry

Tobacco Dependence Clinical Trial

Official title:

Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00968513
• Other study ID #: R01MH083684
• Secondary ID: R01MH083684DAHBR
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 28, 2009
• Last updated: November 19, 2015
• Start date: September 2009
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 956
• Est. completion date: November 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• Brief Intervention
(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
• 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.
• Usual Care
brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization

Locations

Country	Name	City	State
United States	Alta Bates Summit Medical Center	Berkeley	California
United States	UCSF Langley Porter Psychiatric Institute	San Francisco	California
United States	Stanford Hospital and Clinics	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	smoking status		baseline, 3, 6, 12, and 18 months follow-up
Primary	commitment to abstinence		baseline, 3, 6, 12, and 18 months
Primary	quit attempts		3, 6, 12, and 18 months follow-up
Secondary	cost-effectiveness of the extended treatment in terms of cost per expected gain in life year compared to the brief treatment and usual care condition		3, 6, 12, and 18 months
Secondary	Budget Impact Analysis on the incremental cost of adopting the extended and brief smoking cessation treatments in inpatient facilities calculated as a cost per treated person		3, 6, 12, and 18 months follow-up
Secondary	change in psychiatric symptoms and alcohol and illicit drug use		baseline, 3, 6, 12, and 18 months follow-up