Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00968513
First received: August 28, 2009
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Tobacco Dependence
Behavioral: Brief Intervention
Behavioral: Extended Treatment
Behavioral: Usual Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • smoking status [ Time Frame: baseline, 3, 6, 12, and 18 months follow-up ] [ Designated as safety issue: No ]
  • commitment to abstinence [ Time Frame: baseline, 3, 6, 12, and 18 months ] [ Designated as safety issue: No ]
  • quit attempts [ Time Frame: 3, 6, 12, and 18 months follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 3, 6, 12, and 18 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 3, 6, 12, and 18 months follow-up ] [ Designated as safety issue: No ]
  • change in psychiatric symptoms and alcohol and illicit drug use [ Time Frame: baseline, 3, 6, 12, and 18 months follow-up ] [ Designated as safety issue: No ]

Enrollment: 956
Study Start Date: September 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual Care
(N=150) brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization
Behavioral: Usual Care
brief cessation advice, a quit smoking guide, and nicotine replacement provided during hospitalization
Experimental: 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
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
Experimental: 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.
Behavioral: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968513

Locations
United States, California
Alta Bates Summit Medical Center
Berkeley, California, United States, 94704
UCSF Langley Porter Psychiatric Institute
San Francisco, California, United States, 94143
Stanford Hospital and Clinics
Stanford, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Judith J. Prochaska, PhD, MPH Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00968513     History of Changes
Other Study ID Numbers: R01MH083684, R01MH083684, DAHBR A2-AID
Study First Received: August 28, 2009
Last Updated: December 12, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Stanford University:
Smoking Cessation, Inpatient Psychiatry, Stages of Change

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014