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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
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 14, 2013
Last Updated
November 4, 2020
Sponsor
University of Texas at Austin
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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

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