Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry

Stanford University

Status: Completed

Conditions: Tobacco Dependence

Treatments: Behavioral: Brief Intervention; Behavioral: Usual Care; Behavioral: Extended Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00968513

DAHBR A2-AID (Other Grant/Funding Number)

R01MH083684 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

Using a three group additive design, this randomized clinical trial (N=956) aims to evaluate tobacco cessation treatments of varying intensities initiated in the acute psychiatric inpatient setting. The three groups are:

1. Usual Care (N=132) consisting of brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization;
2. Brief Treatment (N=416) 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=408) 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.

Enrollment: 956 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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956 participants in 3 patient groups

Usual Care

Active Comparator group

Description:

(N=132) brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization

Treatment:

Behavioral: Usual Care

Brief Treatment

Experimental group

Description:

(N=416) 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.

Treatment:

Behavioral: Brief Intervention

Extended Treatment

Experimental group

Description:

(N=408) 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.

Treatment:

Behavioral: Extended Treatment