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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00118534
First received: July 1, 2005
Last updated: April 18, 2014
Last verified: April 2014
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CSP #519 - Integrating Practice Guidelines for Smoking Cessation Into Mental Health Care for PTSD (SCP)

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization [ Time Frame: between 6 and 18 months ] [ Designated as safety issue: No ]
    The primary outcome measure was 12-month bio-verified prolonged abstinence from tobacco between 6 and 18 months postrandomization. Prolonged abstinence excluded tobacco use before 6 months postrandomization. Prolonged abstinence defined non-abstinence as 1) smoking for 7 consecutive days or at least once a week for 2 consecutive weeks, or 2) using non-cigarette tobacco for 7 consecutive days or at least once a week for 2 consecutive weeks. Self-reported prolonged abstinence was verified by exhaled CO ≤ 8ppm and urine cotinine <100 ng/mL cotinine equivalents at the 9-18 month visits. If CO or cotinine was missing, a single measure was used for verification. If both CO and cotinine were missing at any visit between 9 and 15 months, patients reporting prolonged abstinence were considered abstinent if all other available bioverification data confirmed abstinence. Patients who lacked CO and cotinine readings at 18 months or failed to attend the 18 month visit were considered nonabstinent.


Secondary Outcome Measures:
  • Self-reported 12-month Prolonged Abstinence Between 6 and 18 Months [ Time Frame: between 6 and 18 months ] [ Designated as safety issue: No ]
    A secondary outcome was self-reported 1-year prolonged abstinence between 6 and 18 months post-randomization. Prolonged abstinence excluded tobacco use prior to 6 months post-randomization to allow for initial treatment episode completion and recovery from early relapses. Prolonged abstinence defined non-abstinence as: 1) smoking for 7 consecutive days or at least once a week for 2 consecutive weeks, or 2) using non-cigarette tobacco for 7 consecutive days or at least once a week for 2 consecutive weeks.

  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
    Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was CAPS at 18 months. The range is 0-136; five rationally derived severity score ranges for interpreting CAPS total score have been proposed and are as follows: 0-19 = asymptomatic/few symptoms, 20-39 = mild PTSD/subthreshold, 40-59 = moderate PTSD/threshold, 60-79 = severe PTSD symptomatology, and >80 = extreme PTSD symptomology. A rationally derived 15-point change in CAPS total severity score has been proposed as a marker of clinically significant change. The above severity ranges and 15-point marker are preliminary (Frank W. Weathers et. al., "Clinician-administered PTSD Scale: A Review of the First Ten Years of Research", Depression and Anxiety 13: 132-156 (2001)). The results are reported in mean change from baseline.

  • PTSD Checklist [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 3 month assessment.

  • PTSD Checklist [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 6 month assessment.

  • PTSD Checklist [ Time Frame: Baseline and 9 months ] [ Designated as safety issue: No ]
    Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 9 month assessment.

  • PTSD Checklist [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 12 month assessment.

  • PTSD Checklist [ Time Frame: Baseline and 15 months ] [ Designated as safety issue: No ]
    Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 15 month assessment.

  • PTSD Checklist [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
    Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 18 month assessment.

  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 3 month assessment.

  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 6 month assessment.

  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline and 9 months ] [ Designated as safety issue: No ]
    The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 9 month assessment.

  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 12 month assessment.

  • Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline and 15 months ] [ Designated as safety issue: No ]
    The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 15 month assessment.

  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
    The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 18 month assessment.

  • 7-day Point Prevalence Abstinence - Self Reported [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.

  • 7-day Point Prevalence Abstinence - Self Reported [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.

  • 7-day Point Prevalence Abstinence - Self Reported [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.

  • 7-day Point Prevalence Abstinence - Self Reported [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.

  • 7-day Point Prevalence Abstinence - Self Reported [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.

  • 7-day Point Prevalence Abstinence - Self Reported [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.

  • 7-day Point Prevalence Abstinence - Bio-Verified [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.

  • 7-day Point Prevalence Abstinence - Bio-Verified [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.

  • 7-day Point Prevalence Abstinence - Bio-Verified [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.

  • 7-day Point Prevalence Abstinence - Bio-Verified [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.

  • 7-day Point Prevalence Abstinence - Bio-Verified [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.

  • 7-day Point Prevalence Abstinence - Bio-Verified [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.

  • 30-day Point Prevalence Abstinence - Self Reported [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.

  • 30-day Point Prevalence Abstinence - Self Reported [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.

  • 30-day Point Prevalence Abstinence - Self Reported [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.

  • 30-day Point Prevalence Abstinence - Self Reported [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.

  • 30-day Point Prevalence Abstinence - Self Reported [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.

  • 30-day Point Prevalence Abstinence - Self Reported [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.

  • 30-day Point Prevalence Abstinence - Bio-Verified [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.

  • 30-day Point Prevalence Abstinence - Bio-Verified [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.

  • 30-day Point Prevalence Abstinence - Bio-Verified [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.

  • 30-day Point Prevalence Abstinence - Bio-Verified [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.

  • 30-day Point Prevalence Abstinence - Bio-Verified [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.

  • 30-day Point Prevalence Abstinence - Bio-Verified [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.


Enrollment: 943
Study Start Date: July 2004
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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.
Other Name: Integrated Care (IC)
Active Comparator: Arm 2
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
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: 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
Investigators
Study Chair: Miles E McFall, PhD VA Puget Sound Health Care System, Seattle
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00118534     History of Changes
Other Study ID Numbers: 519
Study First Received: July 1, 2005
Results First Received: August 22, 2013
Last Updated: April 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
clinical trial
multi-site trial
smoking cessation
smoking cessation medications
addictive disorders
cost effectiveness
mental health
military or environmental exposure
nicotine
nicotine replacement
post traumatic stress
post traumatic stress disorder
psychiatric
psychological
PTSD
substance abuse

Additional relevant MeSH terms:
Smoking
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Tobacco Use Disorder
Substance-Related Disorders
Habits
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014