Trial record 3 of 229 for:    smoking AND heart disease OR smoking | Open Studies | NIH, U.S. Fed

CPT and Smoking Cessation

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01901848
First received: July 12, 2013
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Stress Disorders, Post-Traumatic
Smoking
Behavioral: Cognitive Processing Therapy (CPT)
Drug: Bupropion
Drug: nicotine replacement therapy (NRT)
Behavioral: Integrated Care for Smoking Cessation (ICSC)
Behavioral: smokefreeVET
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Smoking Cessation and Cognitive Processing Therapy for PTSD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • smoking abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Primary study outcome will be smoking abstinence, which will be measured at several time points. The particular time point of interest is six months initial post-quit attempt. Abstinence will be self-reported and bio-verified with carbon monoxide monitoring and saliva sample for cotinine assays.


Estimated Enrollment: 50
Study Start Date: December 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CPT+ICSC
This arm includes 12 sessions of Cognitive Processing Therapy, or CPT, 6 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.
Behavioral: Cognitive Processing Therapy (CPT)
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.
Drug: Bupropion
Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.
Other Name: Zyban
Drug: nicotine replacement therapy (NRT)
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.
Other Name: Nicoderm, Nicorette
Behavioral: Integrated Care for Smoking Cessation (ICSC)
ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.
Behavioral: smokefreeVET
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.
Active Comparator: ICSC only
This arm includes 6 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
Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.
Other Name: Zyban
Drug: nicotine replacement therapy (NRT)
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.
Other Name: Nicoderm, Nicorette
Behavioral: Integrated Care for Smoking Cessation (ICSC)
ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.
Behavioral: smokefreeVET
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.

Detailed Description:

Posttraumatic stress disorder (PTSD) and cigarette smoking are both associated with significant impairment in Veterans and cost to the Veterans' Affairs (VA) system. Though naturalistic and laboratory studies suggest smoking is linked with PTSD symptoms, existing smoking cessation treatments targeting PTSD smokers have not utilized standardized, evidence-based PTSD treatment. The most effective smoking cessation approach to date for PTSD smokers, Integrated Care for Smoking Cessation (ICSC), relies on delivery of smoking cessation treatment by the individual's PTSD treatment provider. In a recent trial comparing ICSC to VA specialty Smoking Cessation Clinic care, ICSC produced significantly better prolonged smoking abstinence. However, ICSC was associated with only modest improvements in PTSD symptoms, with no difference between ICSC and smoking cessation treatment alone, suggesting a likely avenue for improving ICSC. We have developed an intervention that combines evidence based treatment for PTSD [cognitive processing therapy (CPT-C)] with evidence based smoking cessation for PTSD [Integrated Care for Smoking Cessation (ICSC)] and a mobile text messaging program. The primary aim of the proposed study is to evaluate the integration of CPT-C and smoking cessation treatment in an individual 12-session PTSD protocol as compared to a protocol including the same smoking cessation treatment for individuals with PTSD, but without CPT-C. This intervention will be evaluated with the following hypotheses:

  1. Compared to the smoking cessation alone protocol, the smoking cessation + concurrent CPT-C protocol will result in reduced frequency and intensity of PTSD symptoms.
  2. Compared to the smoking cessation alone protocol, the smoking cessation + concurrent CPT-C protocol will result in reduced depressive symptoms.
  3. The smoking cessation + concurrent CPT-C protocol will result in decreased smoking rates, relative to published data on VA smoking cessation usual care.
  4. Greater PTSD symptom reduction during the smoking cessation + concurrent CPT-C treatment will result in longer duration to smoking lapse and relapse.
  5. Exploratory research question: Will candidate genes described earlier predict treatment response in smokers with PTSD?
  6. Exploratory research question: Will use of automated text messaging as an adjunct to smoking cessation be feasible, and will it impact quit rates?

The development of a combined CPT-C/ICSC intervention with established empirical support would benefit the many Veterans with PTSD who smoke by providing them with treatment of two pervasive problems with significant associated impairment. In addition, this treatment could substantially reduce the cost of administering two individual treatments separately by administering them in combination.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01901848

Contacts
Contact: Angela C Kirby, MS (919) 286-0411 ext 7456 angela.kirby@va.gov
Contact: Eric Dedert, PhD (919) 286-0411 ext 5526 Eric.Dedert@va.gov

Locations
United States, North Carolina
VA Medical Center, Durham Recruiting
Durham, North Carolina, United States, 27705
Contact: Angela C Kirby, MS    919-286-0411 ext 7456    angela.kirby@va.gov   
Contact: Eric Dedert, PhD    (919) 286-0411 ext 5526    Eric.Dedert@va.gov   
Principal Investigator: Eric Dedert, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Eric Dedert, PhD VA Medical Center, Durham
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01901848     History of Changes
Other Study ID Numbers: MHBA-018-12F
Study First Received: July 12, 2013
Last Updated: May 22, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Smoking Cessation
Stress Disorders, Post-Traumatic
Psychotherapy

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Nicotine
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014