Stress Disorders, Post-TraumaticPhase 2/3NCT01901848
CPT and Smoking Cessation
A Phase 2/3 study testing Cognitive Processing Therapy (CPT), Bupropion and nicotine replacement therapy (NRT) in people with Stress Disorders, Post-Traumatic and Smoking, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Smoking
- What is being tested?
- Cognitive Processing Therapy (CPT), Bupropion and nicotine replacement therapy (NRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2013to 30 Jul 2017
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
About this study
Official title: Combined Smoking Cessation and Cognitive Processing Therapy for PTSD
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.
Read the 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. The investigators 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:
- Compared to the smoking cessation alone protocol, the smoking cessation + concurrent CPT-C protocol will result in reduced frequency and intensity of PTSD symptoms.
- Compared to the smoking cessation alone protocol, the smoking cessation + concurrent CPT-C protocol will result in reduced depressive symptoms.
- The smoking cessation + concurrent CPT-C protocol will result in decreased smoking rates, relative to published data on VA smoking cessation usual care.
- Greater PTSD symptom reduction during the smoking cessation + concurrent CPT-C treatment will result in longer duration to smoking lapse and relapse.
- Exploratory research question: Will candidate genes described earlier predict treatment response in smokers with PTSD?
- 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.
- Conditions
- Stress Disorders, Post-Traumatic, Smoking
- Being tested
- Cognitive Processing Therapy (CPT), Bupropion, nicotine replacement therapy (NRT), Integrated Care for Smoking Cessation (ICSC), smokefreeVET
- Keywords
- Smoking Cessation, Stress Disorders, Post-Traumatic, Psychotherapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing Therapy (CPT)Behavioural
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
Also called Zyban
Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.
nicotine replacement therapy (NRT)Drug
Also called Nicoderm, Nicorette
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)Behavioural
ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.
smokefreeVETBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Bupropion; Drug: nicotine replacement therapy (NRT); Behavioral: Integrated Care for Smoking Cessation (ICSC); Behavioral: smokefreeVET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study start11 Dec 2013
- Primary completion30 Jul 2017
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Eric A Dedert, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901848
- Sponsor's protocol ID
- MHBA-018-12F
- Status last verified
- Aug 2018
- First submitted
- 12 Jul 2013
- Last updated
- 11 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30664539
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Smoking Cessation and Cognitive Processing Therapy for PTSD
- ClinicalTrials.gov ID
- NCT01901848
- Acronym / sponsor ID
- MHBA-018-12F
- Conditions
- Stress Disorders, Post-Traumatic, Smoking
- Keywords
- Smoking Cessation, Stress Disorders, Post-Traumatic, Psychotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 11 Dec 2013 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Posted 11 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. The investigators 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:
- Compared to the smoking cessation alone protocol, the smoking cessation + concurrent CPT-C protocol will result in reduced frequency and intensity of PTSD symptoms.
- Compared to the smoking cessation alone protocol, the smoking cessation + concurrent CPT-C protocol will result in reduced depressive symptoms.
- The smoking cessation + concurrent CPT-C protocol will result in decreased smoking rates, relative to published data on VA smoking cessation usual care.
- Greater PTSD symptom reduction during the smoking cessation + concurrent CPT-C treatment will result in longer duration to smoking lapse and relapse.
- Exploratory research question: Will candidate genes described earlier predict treatment response in smokers with PTSD?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPT+ICSC | Experimental | Behavioral: Cognitive Processing Therapy (CPT), Drug: Bupropion, Drug: nicotine replacement therapy (NRT), Behavioral: Integrated Care for Smoking Cessation (ICSC), Behavioral: smokefreeVETThis 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. |
| ICSC only | Active comparator | Drug: Bupropion, Drug: nicotine replacement therapy (NRT), Behavioral: Integrated Care for Smoking Cessation (ICSC), Behavioral: smokefreeVETThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CPT+ICSC |
| BupropionAlso: ZybanBupropion is an anti-depressant medication that is commonly used in smoking cessation treatment. | Drug | CPT+ICSC, ICSC only |
| nicotine replacement therapy (NRT)Also: Nicoderm, NicoretteNRT 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. | Drug | CPT+ICSC, ICSC only |
| Integrated Care for Smoking Cessation (ICSC)ICSC is a manualized treatment for smoking cessation involving six sessions of counseling. | Behavioural | CPT+ICSC, ICSC only |
| smokefreeVETSmokefreeVET 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. | Behavioural | CPT+ICSC, ICSC only |
Primary outcome
Number of Participants Who Self-report 7-day Point Prevalence Smoking Abstinence at 6-month Follow-up.
Time frame: 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.
Number of Participants Who Self-reported 7-day Point Prevalence Smoking Abstinence as Bioverified by Breath Carbon Monoxide < 4 Parts Per Million.
Time frame: 6-month follow-up
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30664539Dedert 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric A Dedert, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cognitive Processing Therapy (CPT), Bupropion and nicotine replacement therapy (NRT) in people with Stress Disorders, Post-Traumatic and Smoking, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Self-report 7-day Point Prevalence Smoking Abstinence at 6-month Follow-up. (time frame: 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01901848, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.