Tobacco Treatment as Augmentation for Cognitive Processing Therapy for PTSD



Status:Terminated
Conditions:Smoking Cessation, Psychiatric, Psychiatric, Tobacco Consumers
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2014
End Date:January 2016

Use our guide to learn which trials are right for you!

Tobacco Treatment as Augmentation to Cognitive Processing Therapy for PTSD

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.

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.

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 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.
We found this trial at
1
site
?
mi
from
Boston, MA
Click here to add this to my saved trials