NCT01988935

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

6.7 years

First QC Date

November 14, 2013

Last Update Submit

November 4, 2020

Conditions

Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

  • Smoking Status

    3 months

Secondary Outcomes (3)

  • PTSD Symptoms

    3 months

  • General Mood and Anxiety Symptoms

    3 months

  • Side Effects

    3 months

Study Arms (2)

Prolonged Exposure + Smoking Cessation

EXPERIMENTAL

Prolonged Exposure therapy plus smoking cessation intervention

Behavioral: Prolonged ExposureBehavioral: Smoking Cessation

Smoking Cessation

ACTIVE COMPARATOR

Smoking cessation intervention

Behavioral: Smoking Cessation

Interventions

Prolonged ExposureBEHAVIORAL

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

Prolonged Exposure + Smoking Cessation
Smoking CessationBEHAVIORAL

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

Prolonged Exposure + Smoking CessationSmoking Cessation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

November 14, 2013

First Posted

November 20, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

US(1)