CPT and Smoking Cessation

NCT01901848 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MHBA-018-12F
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress Disorders, Post-Traumatic; Smoking

Keywords

Smoking Cessation; Stress Disorders, Post-Traumatic; Psychotherapy

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Self-report 7-day Point Prevalence Smoking Abstinence at 6-month Follow-up.

  7-day point prevalence abstinence is defined as participant reporting no smoking occasions in the 7 days preceding the 6-month follow-up appointment. The 6-month follow-up occurs 6 months after the initial scheduled quit date.

  6-month follow-up

• Number of Participants Who Self-reported 7-day Point Prevalence Smoking Abstinence as Bioverified by Breath Carbon Monoxide < 4 Parts Per Million.

  Self-reported 7-day point prevalence smoking abstinence was bioverified by breath carbon monoxide level of \< 4 parts per million at the 6-month follow-up.

  6-month follow-up

Study Arms (2)

CPT+ICSC

EXPERIMENTAL

This arm includes 12 sessions of combined Cognitive Processing Therapy (CPT) and Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.

Behavioral: Cognitive Processing Therapy (CPT); Drug: Bupropion; Drug: nicotine replacement therapy (NRT); Behavioral: Integrated Care for Smoking Cessation (ICSC); Behavioral: smokefreeVET

ICSC only

ACTIVE COMPARATOR

This arm includes 12 sessions of Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.

Drug: Bupropion; Drug: nicotine replacement therapy (NRT); Behavioral: Integrated Care for Smoking Cessation (ICSC); Behavioral: smokefreeVET

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.

CPT+ICSC

Bupropion DRUG

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

Also known as: Zyban

CPT+ICSC; ICSC only

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.

Also known as: Nicoderm, Nicorette

CPT+ICSC; ICSC only

Integrated Care for Smoking Cessation (ICSC) BEHAVIORAL

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

CPT+ICSC; ICSC only

smokefreeVET BEHAVIORAL

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.

CPT+ICSC; ICSC only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• Dedert EA, Resick PA, Dennis PA, Wilson SM, Moore SD, Beckham JC. Pilot Trial of a Combined Cognitive Processing Therapy and Smoking Cessation Treatment. J Addict Med. 2019 Jul/Aug;13(4):322-330. doi: 10.1097/ADM.0000000000000502.

  PMID: 30664539 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Smoking; Smoking Cessation

Interventions

Bupropion; Nicotine Replacement Therapy; Nicotine; Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Drug Therapy; Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Tobacco Use Cessation Devices; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Eric Dedert, Ph.D.
• Organization: Durham Veterans Health Care System

eric.dedert@va.gov

919-384-8582

Study Officials

• Eric A Dedert, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: July 17, 2013
• Study Start: December 11, 2013
• Primary Completion: July 30, 2017
• Study Completion: July 30, 2017
• Last Updated: September 11, 2018
• Results First Posted: September 11, 2018

Record last verified: 2018-08

Locations

US (1)