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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02081144
Other study ID # 1401013302
Secondary ID R01CA141479
Status Completed
Phase Phase 1
First received
Last updated
Start date May 2014
Est. completion date October 2014

Study information

Verified date March 2020
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Smokefree TXT Program
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.
Drug:
nicotine replacement patches
Subject will be given 4 weeks of Nicotine Replacement Patches, based on the amount he/she is smoking at baseline.
Nicotine Replacement Gum
Subjects will be given 10 pieces of 2mg Nicotine Replacement Gum x 28 days.
Behavioral:
Faxed Referral CT Smokers Quitline
A faxed referral will be sent to the CT Smokers Quitline for the subject.

Locations

Country Name City State
United States Yale New Haven Hospital New Haven Connecticut

Sponsors (3)

Lead Sponsor Collaborator
Yale University National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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