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NCT02576899 · ClinicalTrials.gov registry record · Phase 1

Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence

A Phase 1 study of Post Traumatic Stress Disorder and Tobacco, sponsored by VA Office of Research and Development.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target
1
Study location

NCT02576899: Completed Phase 1 study of Post Traumatic Stress Disorder and Tobacco, sponsored by VA Office of Research and Development.

NCT02576899 is a Phase 1 study of Post Traumatic Stress Disorder and Tobacco that has completed, run by VA Office of Research and Development. The registered enrollment target is 36 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02576899, a Phase 1 study of Post Traumatic Stress Disorder and Tobacco, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target
1
Study location

Study Summary

Veterans with PTSD have high rates of smoking (34%-86% vs. 18% in the general population) and have substantial difficulties with quitting tobacco. Despite the significant morbidity and mortality associated with smoking, no smoking cessation treatments exist that intensively target PTSD symptoms as an obstacle to quit smoking, although this is a significant barrier to quitting for many Veterans. In addition, no smoking cessation treatments have a large emphasis on improving the functioning of Veterans with PTSD and tobacco dependence, although both PTSD and tobacco use negatively affect functioning across physical, mental health, and social domains. The goal of this SPiRE project is to evaluate Acceptance and Commitment Therapy for Veterans with PTSD and Tobacco Use (ACT-PT), which is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence. ACT-PT specifically targets smoking cravings related to PTSD symptoms and memories of trauma, in addition to difficulties managing PTSD symptoms. negative affect and nicotine withdrawal symptoms during quit attempts. ACT-PT includes structured intervention components that guide Veterans to replace smoking as a coping strategy for PTSD symptoms and memories with alternative coping strategies (e.g., mindfulness, acceptance). And healthy living activities (e.g., engaging in work, expanding social networks, engaging in physical exercise) that are consistent with Veterans' values. This project involves a small randomized clinical trial study of Veteran smokers with PTSD and tobacco dependence randomized to one of two different types of psychosocial treatment: ACT-PT versus the American Lung Association's Freedom From Smoking Program \[FFS\]. This study has two primary aims: 1) evaluate the relative feasibility and acceptability of the two interventions (including ease of recruitment, randomization proportion, staff and Veteran acceptance of the treatment, retention rates, treatmen

Primary Outcome

Smoking outcomes will include a self-report of the number of cigarettes smoked at end of treatment, 1-month follow-up, and the 3-month follow-up, verified by carbon monoxide (CO) breath tests (\< 8 ppm).

Conditions Studied

Post Traumatic Stress Disorder Tobacco

Interventions

  • BEHAVIORAL Acceptance and Commitment Therapy for PTSD and Tobacco Use
  • BEHAVIORAL Freedom From Smoking

Study Locations (1)

Massachusetts

  • Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA - Bedford

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2015-09-01
Est. Completion 2019-12-31
Phase Phase 1
VA Office of Research and Development

1,668 total trials

What the finished NCT02576899 record still lists

NCT02576899 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (95% lower).

The record links to 2 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Acceptance and Commitment Therapy for PTSD and Tobacco Use is the first listed.

NCT02576899 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT02576899 about?

NCT02576899 is a clinical study titled "Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence". Veterans with PTSD have high rates of smoking (34%-86% vs. 18% in the general population) and have substantial difficulties with quitting tobacco. Despite the significant morbidity and mortality associated with smoking, no smoking cessation treatments exist that intensively target PTSD symptoms as a...

What is the current status of trial NCT02576899?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2015-09-01. Estimated completion is 2019-12-31.

What conditions does trial NCT02576899 study?

This clinical trial studies the following conditions: Post Traumatic Stress Disorder, Tobacco.

What interventions are being tested in trial NCT02576899?

The interventions under investigation include: Acceptance and Commitment Therapy for PTSD and Tobacco Use (BEHAVIORAL), Freedom From Smoking (BEHAVIORAL).

Who is sponsoring clinical trial NCT02576899?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02576899 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Post Traumatic Stress 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 NCT02576899's enrollment target sits among peer trials

36 201st of 262 higher than 62 of 262 other Post Traumatic Stress Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Post Traumatic Stress 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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Related registry views

Source: ClinicalTrials.gov NCT02576899, the US trial registry maintained by the National Library of Medicine. NCT02576899 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.