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Integrated PTSD and Smoking Treatment

NCT ID: NCT01988935

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2020-06-30

Brief Summary

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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

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Conditions

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Post-Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Prolonged Exposure + Smoking Cessation

Prolonged Exposure therapy plus smoking cessation intervention

Group Type EXPERIMENTAL

Prolonged Exposure

Intervention Type BEHAVIORAL

Weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders.

Smoking Cessation

Intervention Type BEHAVIORAL

Weekly smoking cessation counseling (cognitive behavioral therapy) plus the nicotine patch to reduce withdrawal symptoms.

Smoking Cessation

Smoking cessation intervention

Group Type ACTIVE_COMPARATOR

Smoking Cessation

Intervention Type BEHAVIORAL

Weekly smoking cessation counseling (cognitive behavioral therapy) plus the nicotine patch to reduce withdrawal symptoms.

Interventions

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Prolonged Exposure

Weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders.

Intervention Type BEHAVIORAL

Smoking Cessation

Weekly smoking cessation counseling (cognitive behavioral therapy) plus the nicotine patch to reduce withdrawal symptoms.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Mark B. Powers

Research Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The University of Texas at Austin

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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1K01DA035930

Identifier Type: NIH

Identifier Source: org_study_id

View Link

NCT01857739

Identifier Type: -

Identifier Source: nct_alias