PTSDQUIT4EVERNCT01990079
Use of Technological Advances to Prevent Smoking Relapse Among Smokers With PTSD
A study testing Bupropion, nicotine replacement therapy and Smoking cessation counseling in people with PTSD and Smoking, run by Duke University at 1 site in United States.
Trial summary
The primary goal of the study is to evaluate the use of a new smart phone application in preventing relapse to smoking among people with PTSD. The technology intervention will combine a mobile system to reward non-smoking, smoking cessation counseling, smoking cessation medications, and use of the smart phone app. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Bupropion, nicotine replacement therapy and Smoking cessation counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets criteria for current PTSD;
- Has current smoking status of at least 10 cigarettes per day (verified with breath carbon monoxide measurement);
- Has been smoking for at least 1 year;
- Is aged 18 to 70;
- Can speak and write current fluent conversation English; and
- Is willing to make a smoking cessation attempt.
Who cannot join
- Is pregnant;
- Has diagnosis, based on DSM-IV criteria, of schizophrenia, schizophreniform disorder, schizoaffective disorder, current psychotic symptoms, delusional disorder, current (not in remission) substance use disorder, and/or current manic episode;
- Will not be stable on medications for the study period;
- Has history of myocardial infarction in past 6 months;
- Uses any other forms of nicotine such as cigars, pipes, or chewing tobacco with unwillingness to stop use during study period; or
- Is currently imprisoned.
- Note: Participants may be excluded or asked to refrain from taking certain study medications if they have a seizure disorder, uncontrolled diabetes, an eating disorder, or current or past cirrhosis or hepatitis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27706
About this study
The primary goal of the study is to evaluate the use of a new smart phone application in preventing relapse to smoking among people with PTSD. The technology intervention will combine a mobile system to reward non-smoking, smoking cessation counseling, smoking cessation medications, and use of the smart phone app. The primary aim is to evaluate how effective this intervention is in preventing smoking relapse compared to another intervention that does not include the app.
Read the detailed description
The primary goal of the current study will be to evaluate the use of a new smart phone application (app; Stay Quit Coach) in preventing relapse to smoking among individuals with PTSD. The enhanced technology intervention will combine mobile contingency management (mCM), guideline-based smoking cessation counseling, bupropion and nicotine replacement therapy (NRT), and use of the Stay Quit Coach. For this study, we will propose a clinical trial with a two-group design in which 20 smokers with PTSD will be randomized to either:
QUIT4EVER, an intervention that combines guideline-based smoking cessation counseling, bupropion and NRT, mCM and Stay Quit Coach.
COMBINED CONTACT CONTROL (CCC) an intervention that is identical to QUIT4EVER except Stay Quit Coach will not be included. The CCC controls for compensation, monitoring, time and attention effects.
Specific aims are to:
AIM 1: evaluate the efficacy of QUIT4EVER on rates of abstinence from cigarettes (assessed with multiple measures including bioverified abstinence) during short and long term abstinence (measured at 3 and 6 months).
Hypothesis 1: QUIT4EVER will be associated with increased long term abstinence (self-reported and bio-verified prolonged abstinence at the 3 and 6 month follow-up).
AIM 2: assess the impact of QUIT4EVER on counseling treatment completion and medication adherence.
Hypothesis 2. Increased abstinence associated with QUIT4EVER will be partially mediated by increased telephone counseling treatment completion and greater medication adherence.
AIM 3: calculate the relative cost-effectiveness of the QUIT4EVER intervention in quality adjusted life years (QALY).
Hypothesis 3: QUIT4EVER based treatment will result in greater cost-effectiveness compared to the control condition as measured by the incremental cost-effectiveness ratio.
Overall, results of this study could lead to a highly efficient, effective, and easily disseminated treatment method for reducing smoking among smokers with PTSD and other psychiatric disorders.
- Being tested
- Bupropion, nicotine replacement therapy, Smoking cessation counseling, mobile contingency management, Stay Quit Coach
- Keywords
- PTSD, smoking
- Medical subject headings
- Stress Disorders, Post-Traumatic, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Also called Zyban, Wellbutrin
All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 3-month follow-up.
nicotine replacement therapyDrug
Also called nicotine gum, patch, inhaler, or lozenge
Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum, nicotine inhaler, or nicotine nasal spray, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Smoking cessation counselingOther
Participants will receive four 20-minute smoking cessation counseling sessions and a participant manual. The four sessions are based on standard cognitive-behavioral therapy techniques shown to be efficacious for smoking cessation.
mobile contingency managementBehavioural
Also called mCM
Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for videos that suggest smoking abstinence.
Stay Quit CoachOther
Also called smart phone app
Stay Quit Coach is a smart phone application that serves as a source of readily available support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. The app guides user in creating tailored plans that include their personal reasons for quitting, interactive tools to help users cope with urges to smoke, motivational messages, support contacts to help users stay smoke free and how to address lapses. Participants assigned to this condition will be asked to use Stay Quit Coach from Session 2 through the 6-month follow-up.
| Study group | Role | What they receive |
|---|---|---|
| QUIT4Ever | Experimental | QUIT4EVER is an intervention that combines 4 guideline-based smoking cessation counseling sessions, bupropion and nicotine replacement therapy, mobile contingency management, and the smart-phone application Stay Quit Coach. Receives: Drug: Bupropion; Drug: nicotine replacement therapy; Other: Smoking cessation counseling; Behavioral: mobile contingency management; Other: Stay Quit Coach |
| Control Contact Condition | Active comparator | This intervention combines 4 guideline-based smoking cessation counseling sessions, bupropion and nicotine replacement therapy, and mobile contingency management. Receives: Drug: Bupropion; Drug: nicotine replacement therapy; Other: Smoking cessation counseling; Behavioral: mobile contingency management |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoking, self-report
Participants' self-report of smoking in the past seven days will be measured at the end of the treatment intervention, and at 3 and 6-month follow-up contacts.
Measured: 6 months follow-up
Secondary outcomes (1)
saliva cotinine
For participants reporting smoking abstinence at 3 and 6-months post treatment follow-ups, we will bio-verify smoking abstinence by collecting saliva samples that will be used to determine salivary cotinine levels.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean C. Beckham, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990079
- Sponsor's protocol ID
- Pro00048990
- Acronym
- QUIT4EVER
- Status last verified
- Sep 2015
- First submitted
- 15 Nov 2013
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hicks TA Bs, Thomas SP, Wilson SM, Calhoun PS, Kuhn ER, Beckham JC. A Preliminary Investigation of a Relapse Prevention Mobile Application to Maintain Smoking Abstinence Among Individuals With Posttraumatic Stress Disorder. J Dual Diagn. 2017 Jan-Mar;13(1):15-20. doi: 10.1080/15504263.2016.1267828. Epub 2016 Dec 5.
PubMed 27918881
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Technological Advances to Prevent Smoking Relapse Among Smokers With PTSD
- ClinicalTrials.gov ID
- NCT01990079
- Acronym / sponsor ID
- QUIT4EVER / Pro00048990
- Keywords
- PTSD, smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of the study is to evaluate the use of a new smart phone application in preventing relapse to smoking among people with PTSD. The technology intervention will combine a mobile system to reward non-smoking, smoking cessation counseling, smoking cessation medications, and use of the smart phone app. The primary aim is to evaluate how effective this intervention is in preventing smoking relapse compared to another intervention that does not include the app.
Detailed description
The primary goal of the current study will be to evaluate the use of a new smart phone application (app; Stay Quit Coach) in preventing relapse to smoking among individuals with PTSD. The enhanced technology intervention will combine mobile contingency management (mCM), guideline-based smoking cessation counseling, bupropion and nicotine replacement therapy (NRT), and use of the Stay Quit Coach. For this study, we will propose a clinical trial with a two-group design in which 20 smokers with PTSD will be randomized to either:
QUIT4EVER, an intervention that combines guideline-based smoking cessation counseling, bupropion and NRT, mCM and Stay Quit Coach.
COMBINED CONTACT CONTROL (CCC) an intervention that is identical to QUIT4EVER except Stay Quit Coach will not be included. The CCC controls for compensation, monitoring, time and attention effects.
Specific aims are to:
AIM 1: evaluate the efficacy of QUIT4EVER on rates of abstinence from cigarettes (assessed with multiple measures including bioverified abstinence) during short and long term abstinence (measured at 3 and 6 months).
Hypothesis 1: QUIT4EVER will be associated with increased long term abstinence (self-reported and bio-verified prolonged abstinence at the 3 and 6 month follow-up).
AIM 2: assess the impact of QUIT4EVER on counseling treatment completion and medication adherence.
Hypothesis 2. Increased abstinence associated with QUIT4EVER will be partially mediated by increased telephone counseling treatment completion and greater medication adherence.
AIM 3: calculate the relative cost-effectiveness of the QUIT4EVER intervention in quality adjusted life years (QALY).
Hypothesis 3: QUIT4EVER based treatment will result in greater cost-effectiveness compared to the control condition as measured by the incremental cost-effectiveness ratio.
Overall, results of this study could lead to a highly efficient, effective, and easily disseminated treatment method for reducing smoking among smokers with PTSD and other psychiatric disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QUIT4Ever | Experimental | Drug: Bupropion, Drug: nicotine replacement therapy, Other: Smoking cessation counseling, Behavioral: mobile contingency management, Other: Stay Quit CoachQUIT4EVER is an intervention that combines 4 guideline-based smoking cessation counseling sessions, bupropion and nicotine replacement therapy, mobile contingency management, and the smart-phone application Stay Quit Coach. |
| Control Contact Condition | Active comparator | Drug: Bupropion, Drug: nicotine replacement therapy, Other: Smoking cessation counseling, Behavioral: mobile contingency managementThis intervention combines 4 guideline-based smoking cessation counseling sessions, bupropion and nicotine replacement therapy, and mobile contingency management. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meets criteria for current PTSD;
- Has current smoking status of at least 10 cigarettes per day (verified with breath carbon monoxide measurement);
- Has been smoking for at least 1 year;
- Is aged 18 to 70;
- Can speak and write current fluent conversation English; and
Key exclusion criteria (7 listed)
- Is pregnant;
- Has diagnosis, based on DSM-IV criteria, of schizophrenia, schizophreniform disorder, schizoaffective disorder, current psychotic symptoms, delusional disorder, current (not in remission) substance use disorder, and/or current manic episode;
- Will not be stable on medications for the study period;
- Has history of myocardial infarction in past 6 months;
- Uses any other forms of nicotine such as cigars, pipes, or chewing tobacco with unwillingness to stop use during study period; or
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 |
|---|---|---|
| BupropionAlso: Zyban, WellbutrinAll participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 3-month follow-up. | Drug | Control Contact Condition, QUIT4Ever |
| nicotine replacement therapyAlso: nicotine gum, patch, inhaler, or lozengeParticipants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum, nicotine inhaler, or nicotine nasal spray, and will be instructed to use the rescue method as needed to reduce cigarette cravings | Drug | Control Contact Condition, QUIT4Ever |
| Smoking cessation counselingParticipants will receive four 20-minute smoking cessation counseling sessions and a participant manual. The four sessions are based on standard cognitive-behavioral therapy techniques shown to be efficacious for smoking cessation. | Other | Control Contact Condition, QUIT4Ever |
| mobile contingency managementAlso: mCMParticipants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for videos that suggest smoking abstinence. | Behavioural | Control Contact Condition, QUIT4Ever |
| Stay Quit CoachAlso: smart phone appStay Quit Coach is a smart phone application that serves as a source of readily available support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. The app guides user in creating tailored plans that include their personal reasons for quitting, interactive tools to help users cope with urges to smoke, motivational messages, support contacts to help users stay smoke free and how to address lapses. Participants assigned to this condition will be asked to use Stay Quit Coach from Session 2 through the 6-month follow-up. | Other | QUIT4Ever |
Primary outcome
smoking, self-report
Time frame: 6 months follow-up
Participants' self-report of smoking in the past seven days will be measured at the end of the treatment intervention, and at 3 and 6-month follow-up contacts.
1 secondary outcome
saliva cotinine
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Derived from this study: PubMed 27918881Hicks TA Bs, Thomas SP, Wilson SM, Calhoun PS, Kuhn ER, Beckham JC. A Preliminary Investigation of a Relapse Prevention Mobile Application to Maintain Smoking Abstinence Among Individuals With Posttraumatic Stress Disorder. J Dual Diagn. 2017 Jan-Mar;13(1):15-20. doi: 10.1080/15504263.2016.1267828. Epub 2016 Dec 5.
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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.
Jean C. Beckham, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupropion, nicotine replacement therapy and Smoking cessation counseling in people with PTSD and Smoking, run by Duke University 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 6 inclusion and 7 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 18 May 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
smoking, self-report (time frame: 6 months follow-up). 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 NCT01990079, 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 18 May 2026.