Use of Technological Advances to Prevent Smoking Relapse Among Smokers With PTSD

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.

Inclusion Criteria:

1. Meets criteria for current PTSD;

2. Has current smoking status of at least 10 cigarettes per day (verified with breath
carbon monoxide measurement);

3. Has been smoking for at least 1 year;

4. Is aged 18 to 70;

5. Can speak and write current fluent conversation English; and

6. Is willing to make a smoking cessation attempt.

Exclusion Criteria:

1. Is pregnant;

2. 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;

3. Will not be stable on medications for the study period;

4. Has history of myocardial infarction in past 6 months;

5. Uses any other forms of nicotine such as cigars, pipes, or chewing tobacco with
unwillingness to stop use during study period; or

6. Is currently imprisoned.

7. 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.