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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00118534 |
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 |
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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 |
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) |
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 |
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1: Experimental
Integration of smoking cessation therapy with PTSD therapy.
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Behavioral: Integrated Care for Smoking Cessation in PTSD patients
Smoking cessation therapy is integrated with PTSD therapy.
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2: Active Comparator
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
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Behavioral: Standard of Care
Patients interested in quitting smoking are referred to a separate smoking cessation clinic, per standard of care.
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Chair: | Miles E McFall, PhD | VA Puget Sound Health Care System, Seattle |
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 History of Changes |
Health Authority: | United States: Federal Government |
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 |
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 |
Pathologic Processes Disease Anxiety Disorders Mental Disorders Tobacco Use Disorder |
Substance-Related Disorders Disorders of Environmental Origin Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |