Texting to Promote Tobacco Abstinence in Emergency Department Smokers: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to test the feasibility of conducting a text based smoking cessation trial with Emergency Department patients who are smokers.

Official Title
-----------------
Texting to Promote Tobacco Abstinence in Emergency Department Smokers: A Pilot Study

Conditions
-----------------
Smoking, Tobacco Abstinence

Intervention / Treatment
-----------------
* Other: Smokefree TXT Program
* Drug: nicotine replacement patches
* Drug: Nicotine Replacement Gum
* Behavioral: Faxed Referral CT Smokers Quitline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older have smoked >= 100 cigarettes lifetime describe themselves as every or some day smokers are able to give written informed consent reside in Connecticut own a cell phone with texting capability. Exclusion Criteria: inability to read or understand English currently receiving formal tobacco dependence treatment current use of tobacco cessation products (patch, gum, inhaler, nasal spray, lozenge, e-cigarette) currently using Zyban (bupropion), Wellbutrin (bupropion) or Chantix (varenicline) for smoking cessation current suicide or homicide risk current psychotic disorder life-threatening or unstable medical or psychiatric condition does not have phone with CT area code and with texting capability lacks capacity to give informed consent leaving the ED against medical advice pregnant, nursing, or trying to conceive incarcerated resides in an extended care facility

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Condition<br>Control or Standard Care condition. No intervention will be provided. | |
| Experimental: Texting + NRT Condition<br>Enrollment in NCI's Smokefree TXT Program 4 weeks of Nicotine Replacement Patches 4 weeks of Nicotine Replacement Gum Faxed Referral CT Smokers Quitline | Other: Smokefree TXT Program<br>* The SmokeFreeTxt program is a library consisting of  130 brief messages that can be proactively sent to smokers' cellphones using software developed and maintained by NCI. The message content is informed by principles of cognitive behavioral therapy. They are sent to smokers at random times of day (during normal waking hours), up to 5 messages per day.<br>Drug: nicotine replacement patches<br>* Subject will be given 4 weeks of Nicotine Replacement Patches, based on the amount he/she is smoking at baseline.<br>Drug: Nicotine Replacement Gum<br>* Subjects will be given 10 pieces of 2mg Nicotine Replacement Gum x 28 days.<br>Behavioral: Faxed Referral CT Smokers Quitline<br>* A faxed referral will be sent to the CT Smokers Quitline for the subject.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survey of satisfaction and usage of Smokefree TXT Program | Study team will develop a survey to assess both subjects' satisfaction with the Smokefree TXT Program and ease of use. | 1 month post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7 day point prevalence abstinence | 7 day point prevalence abstinence will be assessed by asking if the subject has smoked even a puff in the past 7 days. | 1 month post enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Standard Care Condition, Texting + NRT Condition