Integrated PTSD and Smoking Treatment | NCT01988935

Studies
Integrated PTSD and Smoking Treatment

NCT01988935

Sponsor

University of Texas at Austin

Status

Completed

Last Update Posted

Nov 5, 2020Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Post-Traumatic Stress Disorder

Interventions

Prolonged Exposure
Smoking Cessation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013Actual

Primary Completion Date

Jun 2020Actual

Completion Date

Jun 2020Actual

First Submitted Date

Nov 14, 2013

First Submission Date that Met QC Criteria

Nov 14, 2013

First Posted Date

Nov 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2020

Last Update Posted Date

Nov 5, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mark B. Powers, Research Associate Professor, University of Texas at AustinPrincipal Investigator

Lead Sponsor

University of Texas at AustinOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prolonged Exposure + Smoking Cessation	Experimental	Prolonged Exposure therapy plus smoking cessation intervention	Behavioral: Prolonged Exposure Behavioral: Smoking Cessation
Smoking Cessation	Active Comparator	Smoking cessation intervention	Behavioral: Smoking Cessation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prolonged Exposure	Behavioral	Weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders.	Prolonged Exposure + Smoking Cessation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Smoking Status		3 months

Secondary Outcomes

Measure	Description	Time Frame
PTSD Symptoms		3 months
General Mood and Anxiety Symptoms		3 months
Side Effects

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas at Austin		Austin	Texas	78712	United States

Condition Browse Module

MeSH Terms

ID	Term
D013313	Stress Disorders, Post-Traumatic

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided