Integrated PTSD and Smoking Treatment
Primary Purpose
Post-Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolonged Exposure
Smoking Cessation
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorder
Eligibility Criteria
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)
Sites / Locations
- The University of Texas at Austin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prolonged Exposure + Smoking Cessation
Smoking Cessation
Arm Description
Prolonged Exposure therapy plus smoking cessation intervention
Smoking cessation intervention
Outcomes
Primary Outcome Measures
Smoking Status
Secondary Outcome Measures
PTSD Symptoms
General Mood and Anxiety Symptoms
Side Effects
Full Information
NCT ID
NCT01988935
First Posted
November 14, 2013
Last Updated
November 4, 2020
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT01988935
Brief Title
Integrated PTSD and Smoking Treatment
Official Title
Integrated PTSD and Smoking Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prolonged Exposure + Smoking Cessation
Arm Type
Experimental
Arm Description
Prolonged Exposure therapy plus smoking cessation intervention
Arm Title
Smoking Cessation
Arm Type
Active Comparator
Arm Description
Smoking cessation intervention
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure
Intervention Description
Weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders.
Intervention Type
Behavioral
Intervention Name(s)
Smoking Cessation
Intervention Description
Weekly smoking cessation counseling (cognitive behavioral therapy) plus the nicotine patch to reduce withdrawal symptoms.
Primary Outcome Measure Information:
Title
Smoking Status
Time Frame
3 months
Secondary Outcome Measure Information:
Title
PTSD Symptoms
Time Frame
3 months
Title
General Mood and Anxiety Symptoms
Time Frame
3 months
Title
Side Effects
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Integrated PTSD and Smoking Treatment
We'll reach out to this number within 24 hrs