Posttraumatic Stress DisorderNCT02012452
Tobacco Treatment as Augmentation for Cognitive Processing Therapy for PTSD
A study testing Tobacco treatment and Health Education in people with Posttraumatic Stress Disorder and Tobacco Dependence, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to examine whether tobacco affects recovery from PTSD. There are 3 goals of the study; (1) to test if quitting tobacco prior to PTSD treatment affects treatment success, (2) to test how PTSD symptoms change in those who have quit tobacco compared to those who continue to use and (3) to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Tobacco Dependence
- What is being tested?
- Tobacco treatment and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jan 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- current tobacco use (a urine cotinine level 200ng/ml),
- motivation to quit (measured by the 7 on the Biener Contemplation ladder)
- and a current diagnosis of PTSD [as diagnosed by the Clinician Administered PTSD Scale for DSM-5]
Who cannot join
- Exclusion criteria will include current participation in another research study, history of bipolar I disorder,
- schizophreniform disorders except for psychosis NOS due to presence of trauma-related sensory hallucinations,
- cognitive impairment (<25 of the Mini Mental State Exam),
- current suicidality/homicidality requiring clinical intervention or a suicide attempt in the past year,
- inability to provide reliable study data (e.g., provide an adulterated urine sample,
- provide misinformation to study staff including stating differing information to two or more staff members,
Show all 17Show fewer
- attempt to misrepresent self in order to avoid being excluded from the study,
- inability to answer study questions which are used to determine eligibility),
- current non-tobacco substance use disorder (abuse or dependence or a positive drug screen; participants who have been abstinent for greater than 3 months will be allowed to participate),
- participation within the past 6 months in trauma-focused therapy (e.g., Prolonged Exposure, Cognitive Processing Therapy),
- current use of tobacco cessation pharmacotherapy (i.e., nicotine replacement therapy or varenicline),
- current use of benzodiazepines
- serious or uncontrolled medical condition precluding unaided tobacco cessation attempts,
- pregnancy,
- a recent change in psychiatric medications (change occurred <2 months prior to entering the study),
- current participation in another research study.
- In addition, participants must agree to keep psychiatric medication doses stable for the duration of the study (except for dose adjustments for changes in medication blood levels due to tobacco cessation), unless there is a concern for participant safety.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
About this study
Official title: Tobacco Treatment as Augmentation to Cognitive Processing Therapy for PTSD
The purpose of this study is to examine whether tobacco affects recovery from PTSD. There are 3 goals of the study; (1) to test if quitting tobacco prior to PTSD treatment affects treatment success, (2) to test how PTSD symptoms change in those who have quit tobacco compared to those who continue to use and (3) to explore how tobacco use and tobacco withdrawal symptoms change during PTSD treatment.
Read the detailed description
The proposed research aims to examine the effect of tobacco on PTSD symptoms and PTSD recovery as well as the effect of PTSD recovery on tobacco use. This study has 3 aims: (1) to evaluate whether tobacco use interferes with recovery from PTSD during empirically based, trauma focused PTSD treatment. (2) To gather preliminary data about whether tobacco use alleviates PTSD symptoms among continued tobacco users vs. recent quitters. (3) To explore the impact of recovery from PTSD treatment on tobacco use quantity and frequency, tobacco withdrawal symptoms, and craving for tobacco. To test these aims, the investigators propose a randomized two group design where 75 participants are assigned to receive either tobacco treatment (Contingency Management plus Cognitive Behavioral Therapy) or control treatment (Health Education) before completing Cognitive Processing Therapy (CPT) for PTSD. Study outcome variables will be PTSD symptom severity following CPT, PTSD symptom severity during tobacco cessation treatment, and tobacco use and tobacco withdrawal during CPT.
- Conditions
- Posttraumatic Stress Disorder, Tobacco Dependence
- Being tested
- Tobacco treatment, Health Education
- Keywords
- posttraumatic stress disorder, tobacco dependence, cognitive behavioral therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco treatmentBehavioural
participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
Health EducationBehavioural
Participants will be provided education on a variety of health topics and will set health goals around each topic
| Study group | Role | What they receive |
|---|---|---|
| tobacco treatment | Experimental | participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment Receives: Behavioral: Tobacco treatment |
| health education treatment | Sham comparator | Participants will be provided education on a variety of health topics and will set health goals around each topic Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale
posttraumatic stress disorder clinician rated symptom ratings; scores range from 0-80 (with higher scores indicating greater PTSD severity)
Measured: end of 6 week PTSD treatment
Secondary outcomes (1)
Percent Abstinent From Tobacco Use
biochemically confirmed abstinence from tobacco using self-report, cotinine, and CO breath samples
Measured: end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startDec 2014
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: PI moving outside VA- grant not transferable
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.
- Other trials for Posttraumatic Stress DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sandra Japuntich, PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012452
- Sponsor's protocol ID
- NURA-018-13S
- Other IDs
- 1IK2CX000918-01A1
- Status last verified
- Sep 2016
- First submitted
- 26 Sep 2013
- Last updated
- 27 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Treatment as Augmentation to Cognitive Processing Therapy for PTSD
- ClinicalTrials.gov ID
- NCT02012452
- Acronym / sponsor ID
- NURA-018-13S
- Conditions
- Posttraumatic Stress Disorder, Tobacco Dependence
- Keywords
- posttraumatic stress disorder, tobacco dependence, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI moving outside VA- grant not transferable
- Enrolment
- 19 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Dec 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Dec 2013 (estimated)
- Results
- Posted 27 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine whether tobacco affects recovery from PTSD. There are 3 goals of the study; (1) to test if quitting tobacco prior to PTSD treatment affects treatment success, (2) to test how PTSD symptoms change in those who have quit tobacco compared to those who continue to use and (3) to explore how tobacco use and tobacco withdrawal symptoms change during PTSD treatment.
Detailed description
The proposed research aims to examine the effect of tobacco on PTSD symptoms and PTSD recovery as well as the effect of PTSD recovery on tobacco use. This study has 3 aims: (1) to evaluate whether tobacco use interferes with recovery from PTSD during empirically based, trauma focused PTSD treatment. (2) To gather preliminary data about whether tobacco use alleviates PTSD symptoms among continued tobacco users vs. recent quitters. (3) To explore the impact of recovery from PTSD treatment on tobacco use quantity and frequency, tobacco withdrawal symptoms, and craving for tobacco. To test these aims, the investigators propose a randomized two group design where 75 participants are assigned to receive either tobacco treatment (Contingency Management plus Cognitive Behavioral Therapy) or control treatment (Health Education) before completing Cognitive Processing Therapy (CPT) for PTSD. Study outcome variables will be PTSD symptom severity following CPT, PTSD symptom severity during tobacco cessation treatment, and tobacco use and tobacco withdrawal during CPT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tobacco treatment | Experimental | Behavioral: Tobacco treatmentparticipants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment |
| health education treatment | Sham comparator | Behavioral: Health EducationParticipants will be provided education on a variety of health topics and will set health goals around each topic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- current tobacco use (a urine cotinine level 200ng/ml),
- motivation to quit (measured by the 7 on the Biener Contemplation ladder)
- and a current diagnosis of PTSD [as diagnosed by the Clinician Administered PTSD Scale for DSM-5]
Key exclusion criteria (17 listed)
- Exclusion criteria will include current participation in another research study, history of bipolar I disorder,
- schizophreniform disorders except for psychosis NOS due to presence of trauma-related sensory hallucinations,
- cognitive impairment (<25 of the Mini Mental State Exam),
- current suicidality/homicidality requiring clinical intervention or a suicide attempt in the past year,
- inability to provide reliable study data (e.g., provide an adulterated urine sample,
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 |
|---|---|---|
| Tobacco treatmentparticipants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment | Behavioural | tobacco treatment |
| Health EducationParticipants will be provided education on a variety of health topics and will set health goals around each topic | Behavioural | health education treatment |
Primary outcome
Clinician Administered PTSD Scale
Time frame: end of 6 week PTSD treatment
posttraumatic stress disorder clinician rated symptom ratings; scores range from 0-80 (with higher scores indicating greater PTSD severity)
1 secondary outcome
Percent Abstinent From Tobacco Use
Time frame: end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sandra Japuntich, PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco treatment and Health Education in people with Posttraumatic Stress Disorder and Tobacco Dependence, 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 3 inclusion and 17 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: stopped early, as of the sponsor's last update on 27 Oct 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2016). 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?
Clinician Administered PTSD Scale (time frame: end of 6 week PTSD treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2016.