Phase 3
N=50
CPT and Smoking Cessation
Stress Disorders, Post-Traumatic · Smoking
Bottom Line
View on ClinicalTrials.gov: NCT01901848 ↗Enrolled (actual)
50
Serious AEs
5.0%
Results posted
Sep 2018
Primary outcome: Primary: Number of Participants Who Self-report 7-day Point Prevalence Smoking Abstinence at 6-month Follow-up. — 2; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cognitive Processing Therapy (CPT) (Behavioral); Bupropion (Drug); nicotine replacement therapy (NRT) (Drug); Integrated Care for Smoking Cessation (ICSC) (Behavioral); smokefreeVET (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Self-report 7-day Point Prevalence Smoking Abstinence at 6-month Follow-up. |
2; 8 | — |
| PRIMARY Number of Participants Who Self-reported 7-day Point Prevalence Smoking Abstinence as Bioverified by Breath Carbon Monoxide < 4 Parts Per Million. |
2; 4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Must be U.S. Veteran
- Smoke at least ten cigarettes a day
- Meet criteria for current PTSD
- Speak and write fluent conversational English
- Be between 18 and 65 years of age
- Be willing to attempt smoking cessation
- Must have access to a phone capable of receiving text messages
Exclusion Criteria
- Not stable on medications for the study period
- History of myocardial infarction in the past 6 months
- Contraindication to NRT and inability to get medical clearance from primary care provider
- Use of other forms of nicotine such as cigars, pipes, or chewing tobacco.
- Pregnancy
- Inability to complete study measures and tasks independently
- Dementia or other brain disorder, schizophrenia, current manic syndrome, or substance abuse/dependence in the preceding 3 months.
- Currently receiving trauma-focused psychotherapy.
- Currently living in court-ordered residential substance abuse treatment.
Data sourced from ClinicalTrials.gov (NCT01901848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.