Posttraumatic Stress Disorder, Tobacco Dependence
Conditions
Keywords
posttraumatic stress disorder, tobacco dependence, cognitive behavioral therapy
Brief 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.
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.
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
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered PTSD Scale | end of 6 week PTSD treatment | posttraumatic stress disorder clinician rated symptom ratings; scores range from 0-80 (with higher scores indicating greater PTSD severity) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Abstinent From Tobacco Use | end of treatment | biochemically confirmed abstinence from tobacco using self-report, cotinine, and CO breath samples |
Countries
United States
Participant flow
Recruitment details
19 participants came in for an in-person screening visit. Of those, 9 met inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Tobacco Treatment participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment | 7 |
| Health Education Treatment Participants will be provided education on a variety of health topics and will set health goals around each topic
Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic | 2 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Tobacco Treatment | Health Education Treatment | Total |
|---|---|---|---|
| Age, Continuous | 57.35 years STANDARD_DEVIATION 7.24 | 57.05 years STANDARD_DEVIATION 9.66 | 57.12 years STANDARD_DEVIATION 8.75 |
| Clinical Administered PTSD scale | 40.86 units on a scale STANDARD_DEVIATION 14.51 | 50.0 units on a scale STANDARD_DEVIATION 8.49 | 42.89 units on a scale STANDARD_DEVIATION 13.53 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 1 Participants | 7 Participants |
| Region of Enrollment United States | 7 participants | 2 participants | 9 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 6 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 7 | 0 / 2 |
| serious Total, serious adverse events | 0 / 7 | 1 / 2 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tobacco Treatment | Clinician Administered PTSD Scale | 18.67 units on a scale | Standard Deviation 8.33 |
| Health Education Treatment | Clinician Administered PTSD Scale | 12 units on a scale | Standard Deviation 0 |
Secondary
Percent Abstinent From Tobacco Use
biochemically confirmed abstinence from tobacco using self-report, cotinine, and CO breath samples
Time frame: end of treatment
Population: If participants did not come the follow-up visit they were assumed to be smokers. If they attended a later follow-up visit, tobacco use was retroactively assessed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tobacco Treatment | Percent Abstinent From Tobacco Use | 14.3 percent abstinent |
| Health Education Treatment | Percent Abstinent From Tobacco Use | 0 percent abstinent |