CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 69 enrolled
Drug / intervention
Bupropion +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01901848
NCT01901848Phase 3Completed

Combined Smoking Cessation and Cognitive Processing Therapy for PTSD

VA Office of Research and Development·interventional·Posted Jul 17, 2013·Updated Sep 11, 2018

In Brief

A Phase 3 clinical trial evaluating Cognitive Processing Therapy (CPT), Bupropion, and 3 other interventions for Stress Disorders, Post-Traumatic and Smoking. Completed, enrolled 69 participants across 1 site.

Detailed Summary

Posttraumatic stress disorder (PTSD) and cigarette smoking are both associated with significant impairment in Veterans and cost to the Veterans' Affairs (VA) system. Though research suggests smoking is linked with PTSD symptoms, existing smoking cessation treatments targeting PTSD smokers do not include PTSD treatment. The purpose of this study is to examine a treatment that combines evidence based treatment for PTSD (cognitive processing therapy, or CPT) with smoking cessation treatment for PTSD and a mobile text messaging program. The study objectives are to evaluate feasibility of the treatment and to examine effectiveness of CPT and smoking cessation treatment combined compared to smoking cessation treatment without CPT. Fifty Veteran smokers with PTSD will participate in fourteen study sessions, ending with the final follow-up session six months after the scheduled quit date.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 17, 2013
Enrollment StartDec 11, 2013
Primary CompletionJul 30, 2017
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 13.0 years ago

Interventions

Cognitive Processing Therapy (CPT)behavioral

CPT is based on a social cognitive theory of PTSD that includes primary emotional responses to traumatic events such as fear, anger, and sadness, as well as secondary emotions resulting from a patient's faulty interpretations of the traumatic event. CPT addresses PTSD by facilitating affective expression so that affective components of the trauma memory can be altered. In addition, faulty beliefs about the trauma are challenged and modified using Socratic questioning.

Bupropiondrug

Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.

nicotine replacement therapy (NRT)drug

NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum, lozenge, inhaler) will be prescribed for participants for use on/after quit date.

Integrated Care for Smoking Cessation (ICSC)behavioral

ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.

smokefreeVETbehavioral

SmokefreeVET is a program that was developed by the National Institutes of Health and Department of Veterans Affairs. The program includes a text messaging protocol for reaching out to Veterans who wish to stop smoking.