Integrated PTSD and Smoking Treatment

The University of Texas System (UT)

Status: Completed

Conditions: Post-Traumatic Stress Disorder

Treatments: Behavioral: Smoking Cessation; Behavioral: Prolonged Exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT01988935

1K01DA035930

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

70 participants in 2 patient groups

Prolonged Exposure + Smoking Cessation

Experimental group

Description:

Prolonged Exposure therapy plus smoking cessation intervention

Treatment:

Behavioral: Smoking Cessation

Behavioral: Prolonged Exposure

Smoking Cessation

Active Comparator group

Description:

Smoking cessation intervention

Treatment:

Behavioral: Smoking Cessation