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NCT00118534 · ClinicalTrials.gov registry record · NA

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

A NA study of Tobacco Use Disorder and Stress Disorders, Post-Traumatic, sponsored by US Department of Veterans Affairs.

Completed
Registry status
NA
Development phase
943
Enrollment target
11
Study locations

NCT00118534: Completed NA study of Tobacco Use Disorder and Stress Disorders, Post-Traumatic, sponsored by US Department of Veterans Affairs.

NCT00118534 is a NA study of Tobacco Use Disorder and Stress Disorders, Post-Traumatic that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 943 participants, above the 226-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (317% higher). The trial reports 11 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00118534, a NA study of Tobacco Use Disorder and Stress Disorders, Post-Traumatic, has completed, sponsored by US Department of Veterans Affairs.

COMPLETED
Registry status
NA
Development phase
943 participants
Enrollment target
11
Study locations

Study Summary

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.

Primary Outcome

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 exhal

Interventions

  • BEHAVIORAL Standard of Care
  • BEHAVIORAL Integrated Care for Smoking Cessation in PTSD patients

Study Locations (11)

Alabama

  • VA Medical Center, Tuscaloosa - Tuscaloosa

California

  • VA San Diego Healthcare System, San Diego - San Diego

District of Columbia

  • VA Medical Center, DC - Washington D.C.

Louisiana

  • Southeast Veterans Healthcare System, New Orleans - New Orleans

Minnesota

  • VA Medical Center, Minneapolis - Minneapolis

Oregon

  • VA Medical Center, Portland - Portland

Pennsylvania

  • VA Medical Center, Philadelphia - Philadelphia

Rhode Island

  • VA Medical Center, Providence - Providence

Trial Details

FieldValue
Enrollment Target 943 participants
Start Date 2004-07
Est. Completion 2009-06
Phase NA
US Department of Veterans Affairs

632 total trials

What the finished NCT00118534 record still lists

NCT00118534 is an interventional study that assigns participants to a tested intervention. The registered 943 participants enrollment target is mid-sized for trials with a published cap, above the 226-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (317% higher).

The record links to 4 conditions, with Tobacco Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.

NCT00118534 lists 11 locations in 11 states (Alabama, California, District of Columbia).

Frequently Asked Questions

What is clinical trial NCT00118534 about?

NCT00118534 is a clinical study titled "Integrating Clinical Practice Guidelines for Smoking Cessation Into Mental Health Care for Veterans With Posttraumatic Stress Disorder". 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 integrat...

What is the current status of trial NCT00118534?

This trial is currently completed. It is a NA study. The enrollment target is 943 participants. The study started on 2004-07. Estimated completion is 2009-06.

What conditions does trial NCT00118534 study?

This clinical trial studies the following conditions: Tobacco Use Disorder, Stress Disorders, Post-Traumatic, Substance-Related Disorders, Mental Health.

What interventions are being tested in trial NCT00118534?

The interventions under investigation include: Standard of Care (BEHAVIORAL), Integrated Care for Smoking Cessation in PTSD patients (BEHAVIORAL).

Who is sponsoring clinical trial NCT00118534?

This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00118534 being conducted?

This trial has 11 study locations across Alabama, California, District of Columbia, Louisiana, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Tobacco Use Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00118534's enrollment target sits among peer trials

943 3rd of 70 higher than 68 of 70 other Tobacco Use Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Tobacco Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00118534, the US trial registry maintained by the National Library of Medicine. NCT00118534 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.