Integrating Clinical Practice Guidelines for Smoking Cessation Into Mental Health Care for Veterans With Posttraumatic Stress Disorder - Full Text View

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00118534

Purpose

The primary study objective is to conduct a prospective, randomized controlled clinical trial that compares the effectiveness of two approaches for delivering smoking cessation treatment for veterans with posttraumatic stress disorder (PTSD). An approach where smoking cessation treatment is integrated into mental health care for PTSD and delivered by mental health providers (experimental condition) will be compared to specialized smoking cessation clinic referral (VA's usual standard of care).

Secondary study objectives are to (a) compare the cost outcomes and cost-effectiveness of IC versus USC, (b) identify treatment process variables that explain (mediate) observed differences in smoking abstinence rates for the two study conditions, and (c) determine whether cessation from smoking is associated with worsening of symptoms of PTSD and/or depression.

Condition	Intervention
Mental Health Stress Disorders, Post-Traumatic Substance-Related Disorders Tobacco Use Disorder	Behavioral: Integrated Care for Smoking Cessation in PTSD patients Behavioral: Standard of Care

MedlinePlus related topics: Mental Health Post-Traumatic Stress Disorder Quitting Smoking Smoking

Drug Information available for: Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	CSP # - 519, Integrating Practice Guidelines for Smoking Cessation Into Mental Health Care for PTSD (SCP)

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Prolonged smoking cessation [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment:	945
Study Start Date:	July 2004
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Integration of smoking cessation therapy with PTSD therapy.	Behavioral: Integrated Care for Smoking Cessation in PTSD patients Smoking cessation therapy is integrated with PTSD therapy.
2: Active Comparator Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.	Behavioral: Standard of Care Patients interested in quitting smoking are referred to a separate smoking cessation clinic, per standard of care.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Receive a minimum of four mental health treatment sessions from the SOPP that span at least a 1-month interval
SOPP treatment plan must indicate intent to deliver ongoing PTSD care for at least 1 year, including visits at least once per month
Diagnosis of PTSD resulting from military trauma using DSM-IV criteria
Current nicotine use, smoking greater at least 10 cigarettes per day for at least 16 of the past 30 days prior to randomization
Demonstrated motivation to quit smoking

Exclusion Criteria:

Use of smokeless tobacco or smoke pipes or cigars
Any psychotic disorder that is not in remission
Bipolar disorder that is not in remission
Any substance dependence disorder that is not in remission (current substance abuse disorder and substance dependence disorder in remission for more than 1 month are not exclusions)
Imminent risk for suicide or violence, as determined during routine assessment by SOPP clinical staff
Severe psychiatric symptoms or psychosocial instability likely to prevent participation in the study protocol (i.e., attendance at scheduled sessions, ability to read study materials, and/or ability to comprehend interventions), as determined during routine assessment by SOPP clinical staff
Gross impairment from organic mental disorder, as determined during routine assessment by SOPP clinical staff

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118534

Locations

United States, Alabama
VA Medical Center, Tuscaloosa
Tuscaloosa, Alabama, United States, 35404
United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
United States, District of Columbia
VA Medical Center, DC
Washington, District of Columbia, United States, 20422
United States, Louisiana
Southeast Veterans Healthcare System, New Orleans
New Orleans, Louisiana, United States, 70112
United States, Minnesota
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201
United States, Pennsylvania
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
VA Medical Center, Providence
Providence, Rhode Island, United States, 02908
United States, Texas
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
United States, Virginia
VA Medical Center, Hampton
Hampton, Virginia, United States, 23667
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Study Chair:

Miles E McFall, PhD

VA Puget Sound Health Care System, Seattle

More Information

Responsible Party:	Department of Veterans Affairs ( McFall, Miles - Study Chair )
Study ID Numbers:	519
Study First Received:	July 1, 2005
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00118534
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

addictive disorders
clinical trial
cost effectiveness
mental health
military or environmental exposure
multi-site trial
nicotine
nicotine replacement

post traumatic stress
post traumatic stress disorder
psychiatric
psychological
PTSD
smoking cessation
smoking cessation medications
substance abuse

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Anxiety Disorders
Nicotine
Mental Disorders
Tobacco Use Disorder

Substance-Related Disorders
Disorders of Environmental Origin
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009