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

Not Applicable

Completed

• Conditions: PTSD; Smoking
• Interventions: Drug: Bupropion; Drug: nicotine replacement therapy; Other: Smoking cessation counseling; Behavioral: mobile contingency management; Other: Stay Quit Coach

• Registration Number: NCT01990079
• Lead Sponsor: Duke University

Brief 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. 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 Timeline

• Study First Submitted: 2013-11-15
• Study First Submitted QC: 2013-11-15
• Study First Posted: 2013-11-21
• Study Start: 2013-12
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-15
• Last Update Posted: 2015-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Contact Condition	nicotine replacement therapy	This intervention combines 4 guideline-based smoking cessation counseling sessions, bupropion and nicotine replacement therapy, and mobile contingency management.
QUIT4Ever	mobile contingency management	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.
QUIT4Ever	nicotine replacement therapy	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.
Control Contact Condition	mobile contingency management	This intervention combines 4 guideline-based smoking cessation counseling sessions, bupropion and nicotine replacement therapy, and mobile contingency management.
QUIT4Ever	Smoking cessation counseling	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.
Control Contact Condition	Smoking cessation counseling	This intervention combines 4 guideline-based smoking cessation counseling sessions, bupropion and nicotine replacement therapy, and mobile contingency management.
QUIT4Ever	Stay Quit Coach	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.
QUIT4Ever	Bupropion	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.
Control Contact Condition	Bupropion	This intervention combines 4 guideline-based smoking cessation counseling sessions, bupropion and nicotine replacement therapy, and mobile contingency management.

Primary Outcome Measures

Name	Time	Method
smoking, self-report	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.

Secondary Outcome Measures

Name	Time	Method
saliva cotinine	6 months	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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States