Integrated PTSD and Smoking Treatment

Not Applicable

Completed

• Conditions: Post-Traumatic Stress Disorder
• Interventions: Behavioral: Prolonged Exposure; Behavioral: Smoking Cessation

• Registration Number: NCT01988935
• Lead Sponsor: University of Texas at Austin

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-14
• Study First Submitted QC: 2013-11-14
• Study First Posted: 2013-11-20
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prolonged Exposure + Smoking Cessation	Prolonged Exposure	Prolonged Exposure therapy plus smoking cessation intervention
Smoking Cessation	Smoking Cessation	Smoking cessation intervention
Prolonged Exposure + Smoking Cessation	Smoking Cessation	Prolonged Exposure therapy plus smoking cessation intervention

Primary Outcome Measures

Name	Time	Method
Smoking Status	3 months

Secondary Outcome Measures

Name	Time	Method
PTSD Symptoms	3 months
General Mood and Anxiety Symptoms	3 months
Side Effects	3 months

Trial Locations

Locations (1)

The University of Texas at Austin; 🇺🇸 Austin, Texas, United States