TerminatedNCT02012452Updated Oct 27, 2016Results posted

Tobacco Treatment as Augmentation for Cognitive Processing Therapy for PTSD

An interventional study of Tobacco treatment and Health Education in Posttraumatic Stress Disorder and Tobacco Dependence, sponsored by VA Office of Research and Development. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-27.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

Why this study was terminated

PI moving outside VA- grant not transferable

Phase: Not applicable
Study type: Interventional
Enrollment: 19
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to examine whether tobacco affects recovery from PTSD. There are 3 goals of the study; (1) to test if quitting tobacco prior to PTSD treatment affects treatment success, (2) to test how PTSD symptoms change in those who have quit tobacco compared to those who continue to use and (3) to explore how tobacco use and tobacco withdrawal symptoms change during PTSD treatment.

Read the detailed description

The proposed research aims to examine the effect of tobacco on PTSD symptoms and PTSD recovery as well as the effect of PTSD recovery on tobacco use. This study has 3 aims: (1) to evaluate whether tobacco use interferes with recovery from PTSD during empirically based, trauma focused PTSD treatment. (2) To gather preliminary data about whether tobacco use alleviates PTSD symptoms among continued tobacco users vs. recent quitters. (3) To explore the impact of recovery from PTSD treatment on tobacco use quantity and frequency, tobacco withdrawal symptoms, and craving for tobacco. To test these aims, the investigators propose a randomized two group design where 75 participants are assigned to receive either tobacco treatment (Contingency Management plus Cognitive Behavioral Therapy) or control treatment (Health Education) before completing Cognitive Processing Therapy (CPT) for PTSD. Study outcome variables will be PTSD symptom severity following CPT, PTSD symptom severity during tobacco cessation treatment, and tobacco use and tobacco withdrawal during CPT.

Conditions studied

Posttraumatic Stress Disorder
Tobacco Dependence

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Keywords

posttraumatic stress disorder
tobacco dependence
cognitive behavioral therapy

In context

Tobacco Use Disorder

968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.

This study's enrollment of 19 is below the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.

Browse Tobacco Use Disorder studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

current tobacco use (a urine cotinine level 200ng/ml),
motivation to quit (measured by the 7 on the Biener Contemplation ladder)
and a current diagnosis of PTSD [as diagnosed by the Clinician Administered PTSD Scale for DSM-5]

Exclusion criteria

Exclusion Criteria:

Exclusion criteria will include current participation in another research study, history of bipolar I disorder,
schizophreniform disorders except for psychosis NOS due to presence of trauma-related sensory hallucinations,
cognitive impairment (\<25 of the Mini Mental State Exam),
current suicidality/homicidality requiring clinical intervention or a suicide attempt in the past year,
inability to provide reliable study data (e.g., provide an adulterated urine sample,
provide misinformation to study staff including stating differing information to two or more staff members,
attempt to misrepresent self in order to avoid being excluded from the study,
inability to answer study questions which are used to determine eligibility),
current non-tobacco substance use disorder (abuse or dependence or a positive drug screen; participants who have been abstinent for greater than 3 months will be allowed to participate),
participation within the past 6 months in trauma-focused therapy (e.g., Prolonged Exposure, Cognitive Processing Therapy),
current use of tobacco cessation pharmacotherapy (i.e., nicotine replacement therapy or varenicline),
current use of benzodiazepines
serious or uncontrolled medical condition precluding unaided tobacco cessation attempts,
pregnancy,
a recent change in psychiatric medications (change occurred \<2 months prior to entering the study),
current participation in another research study.
In addition, participants must agree to keep psychiatric medication doses stable for the duration of the study (except for dose adjustments for changes in medication blood levels due to tobacco cessation), unless there is a concern for participant safety.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 19 participants (actual)

Study arms

Experimental
tobacco treatment
participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
Behavioral: Tobacco treatment
Sham comparator
health education treatment
Participants will be provided education on a variety of health topics and will set health goals around each topic
Behavioral: Health Education

Interventions

BehavioralTobacco treatment
participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
BehavioralHealth Education
Participants will be provided education on a variety of health topics and will set health goals around each topic

What researchers measure

Primary outcomes

Clinician Administered PTSD Scale
posttraumatic stress disorder clinician rated symptom ratings; scores range from 0-80 (with higher scores indicating greater PTSD severity)
Time frame: end of 6 week PTSD treatment

Secondary outcomes

Percent Abstinent From Tobacco Use
biochemically confirmed abstinence from tobacco using self-report, cotinine, and CO breath samples
Time frame: end of treatment

Results

Posted Oct 27, 2016

Participant flow

19 participants came in for an in-person screening visit. Of those, 9 met inclusion criteria.

Participant flow — Overall Study
Milestone	Tobacco Treatment	Health Education Treatment
Started	7	2
Completed	1	1
Not completed	6	1
Withdrew: Lost to follow-up	2	1
Withdrew: Withdrawal by subject	4	0

Outcome measures

PrimaryClinician Administered PTSD Scale

posttraumatic stress disorder clinician rated symptom ratings; scores range from 0-80 (with higher scores indicating greater PTSD severity)

Time frame:: end of 6 week PTSD treatment
Reported as:: Mean · units on a scale

Clinician Administered PTSD Scale
units on a scale	Tobacco Treatment	Health Education Treatment
Clinician Administered PTSD Scale	18.67 ± 8.33	12 ± 0

SecondaryPercent Abstinent From Tobacco Use

biochemically confirmed abstinence from tobacco using self-report, cotinine, and CO breath samples

Time frame:: end of treatment
Reported as:: Number · percent abstinent

Percent Abstinent From Tobacco Use
percent abstinent	Tobacco Treatment	Health Education Treatment
Percent Abstinent From Tobacco Use	14.3	0

Adverse events

Collected over 25 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Tobacco Treatment	—	0/7 (0%)	1/7 (14.3%)
Health Education Treatment	—	1/2 (50%)	0/2 (0%)

Most frequent serious events

Most frequent serious events
Event	Tobacco Treatment	Health Education Treatment
hospitalizationGastrointestinal disorders	0/7	1/2

Most frequent other events

Most frequent other events
Event	Tobacco Treatment	Health Education Treatment
psychosisPsychiatric disorders	1/7	0/2

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Tobacco Treatment	Health Education Treatment	Total
Mean	57.35 ± 7.24	57.05 ± 9.66	57.12 ± 8.75

Sex: Female, Male
Sex: Female, Male(Participants)	Tobacco Treatment	Health Education Treatment	Total
Female	1	0	1
Male	6	2	8

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Tobacco Treatment	Health Education Treatment	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	1	1	2
White	6	1	7
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Tobacco Treatment	Health Education Treatment	Total
United States	7	2	9

Clinical Administered PTSD scale
Clinical Administered PTSD scale(units on a scale)	Tobacco Treatment	Health Education Treatment	Total
Mean	40.86 ± 14.51	50.0 ± 8.49	42.89 ± 13.53

Study locations

1 site

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts 02130, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02012452
Lead sponsor: VA Office of Research and Development
Responsible party: Sponsor
First posted: Dec 16, 2013
Start date: Dec 2014
Primary completion: Jan 2016
Completion: Jan 2016
Results posted: Oct 27, 2016
Last update: Oct 27, 2016

Study contacts

Sandra Japuntich, PhD

principal investigator · VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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