Integrated PTSD and Smoking Treatment

Post-Traumatic Stress Disorder Clinical Trial

Official title:

Integrated PTSD and Smoking Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988935
• Other study ID #: 1K01DA035930
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: June 2020

Study information

• Verified date: November 2020
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT01857739

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Prolonged Exposure
Weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders.
• Smoking Cessation
Weekly smoking cessation counseling (cognitive behavioral therapy) plus the nicotine patch to reduce withdrawal symptoms.

Locations

Country	Name	City	State
United States	The University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Status		3 months
Secondary	PTSD Symptoms		3 months
Secondary	General Mood and Anxiety Symptoms		3 months
Secondary	Side Effects		3 months