Integrated PTSD and Smoking Treatment

Study Overview
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Brief Summary
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Research shows that people with PTSD are more likely to smoke than people without PTSD. It also shows that people with PTSD have more difficulty at attempts to quit smoking. This study is part of a program aimed at finding out how best to help smokers quit who also have PTSD. One option is to give patients standard smoking cessation treatment including nicotine replacement and cognitive behavioral therapy. Another option is to give patients the standard smoking cessation treatment in addition to treatment for their PTSD symptoms (called prolonged exposure). However, it is not known which method works better. In order to answer this question, patients will be assigned by chance to one of two groups. One group will be given standard smoking cessation treatment to help quit smoking. A second group will be given the standard smoking cessation intervention to help quit smoking in addition to a form of psychotherapy called Prolonged Exposure to reduce symptoms of PTSD. The patients will be randomly assigned (by chance) to one of these groups. If the patient is assigned to the smoking cessation only condition and the patient still has PTSD symptoms after the last study visit (week 30) the patient will be offered treatment for your PTSD symptoms (Prolonged Exposure) at no cost. The patient's participation will help the investigators determine if treating PTSD symptoms enhances the ability of standard smoking cessation to help people quit smoking.

Official Title
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Integrated PTSD and Smoking Treatment

Conditions
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Post-Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Prolonged Exposure
* Behavioral: Smoking Cessation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: You have PTSD You currently smoke more than 8 cigarettes per day You have a motivation to quit smoking You are between the age of 18 and 65. Exclusion Criteria: You are currently using other tobacco products (other than cigarettes) You have any history of a suicide attempt, or are at significant risk of self-harm or harm to others You have severe depression You have any history of bipolar disorder, psychotic disorder You have a diagnosis of eating disorder, or substance abuse or dependence (excluding nicotine) within the past six months You are currently receiving other treatment specifically for PTSD or smoking cessation You are unable to read and speak English (as the materials are provided in English)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prolonged Exposure + Smoking Cessation<br>Prolonged Exposure therapy plus smoking cessation intervention | Behavioral: Prolonged Exposure<br>* Weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders.<br>Behavioral: Smoking Cessation<br>* Weekly smoking cessation counseling (cognitive behavioral therapy) plus the nicotine patch to reduce withdrawal symptoms.<br>|
| Active Comparator: Smoking Cessation<br>Smoking cessation intervention | Behavioral: Smoking Cessation<br>* Weekly smoking cessation counseling (cognitive behavioral therapy) plus the nicotine patch to reduce withdrawal symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Status |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Symptoms |  | 3 months | 
| General Mood and Anxiety Symptoms |  | 3 months | 
| Side Effects |  | 3 months |