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Smoking Cessation for Veterans With Severe and Persistent Mental Illness

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ClinicalTrials.gov Identifier: NCT00960375
Recruitment Status : Completed
First Posted : August 17, 2009
Results First Posted : June 23, 2015
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The investigators have developed an intervention called Behavioral Treatment of Smoking Cessation in SPMI (BTSCS), an innovative intervention that supplements pharmacotherapy and education with contingency management and a multifaceted behavioral group treatment program that lasts for three months (24 group meetings). BTSCS is designed to address the cognitive, motivational, and social support problems characteristic of people with SPMI.

The investigators propose to conduct a randomized trial for persons with SPMI that compares (1) BTSCS: a 6-month manualized smoking cessation program adapted from an effective substance abuse treatment program for this population to (2) StSST: a standard manualized smoking cessation program which reflects current best practices.


Condition or disease Intervention/treatment Phase
Schizoaffective Disorder Schizophrenia Affective Psychosis, Bipolar Affective Disorders, Psychotic Behavioral: BTSCS Behavioral: StSST Phase 2 Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of a Smoking Cessation Program for Persons With SMI
Study Start Date : April 2010
Primary Completion Date : March 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: BTSCS
BTSCS lasts 3 months, includes two 60-minute group meetings per week (24 group meetings total), and is delivered in small groups of 4-8 participants run by a trained interventionist. BTSCS includes: (1) An individual motivational enhancement meeting during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Breath carbon monoxide monitoring and goal-setting at the beginning of each meeting; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
Behavioral: BTSCS
BTSCS lasts 3 months, includes two 60-minute group meetings per week (24 group meetings total), and is delivered in small groups of 4-8 participants run by a trained interventionist. BTSCS includes: (1) An individual motivational enhancement meeting during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Breath carbon monoxide monitoring and goal-setting at the beginning of each meeting; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
Active Comparator: StSST
The StSST program is adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meet twice per week for 3 months (24 sessions total). Participants complete a breath carbon monoxide test at the start of each group meeting. StSST groups provide education about smoking and support for quitting.
Behavioral: StSST
The StSST program is adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meet twice per week for 3 months (24 sessions total). Participants complete a breath carbon monoxide (CO) test at the start of each group. StSST groups provide education about smoking and support for quitting.


Outcome Measures

Primary Outcome Measures :
  1. Number of Cigarettes Smoked Per Day [ Time Frame: day ]
    Number of cigarettes smoked per day for the last 7 days

  2. Abstinence From Tobacco [ Time Frame: 7 days ]
    Self-reported abstinence from tobacco + breath CO < 10 ppm


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV diagnosis of severe and persistent mental illness (SPMI) including a diagnosis of a psychotic disorder in keeping with criteria established by the Serious Mental Illness Treatment Research and Evaluation Center (SMITREC) -Schizophrenic disorders, affective psychoses and other psychotic diagnoses. We also include individuals with a diagnosis of Major Depression with psychotic features and PTSD.
  • Age 18-75
  • Nicotine dependence as defined by a score of 5 or higher on the Fagerstrom Tolerance Scale OR Participants who currently smoke at least 10 cigarettes per day
  • Participants will not meet criteria for current alcohol/substance dependence (other than nicotine)
  • Willingness ability to provide consent to participate.

Exclusion Criteria:

  • Documented history of severe neurological disorder or severe head trauma with loss of consciousness
  • Severe or profound mental retardation by chart review.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960375


Locations
United States, District of Columbia
Washington DC VA Medical Center, Washington, DC
Washington, District of Columbia, United States, 20422
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Melanie E Bennett Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00960375     History of Changes
Other Study ID Numbers: NURA-001-09S
First Posted: August 17, 2009    Key Record Dates
Results First Posted: June 23, 2015
Last Update Posted: August 18, 2015
Last Verified: July 2015

Keywords provided by VA Office of Research and Development:
smoking cessation
serious mental illness

Additional relevant MeSH terms:
Disease
Schizophrenia
Psychotic Disorders
Mood Disorders
Mental Disorders
Affective Disorders, Psychotic
Bipolar Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs