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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01516632
Other study ID # R21CA135669
Secondary ID 5R21CA135669
Status Completed
Phase Phase 1/Phase 2
First received March 15, 2011
Last updated January 24, 2012
Start date June 2009
Est. completion date December 2011

Study information

Verified date January 2012
Source Center for Innovative Public Health Research
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The investigators are developing a testing a text messaging-based smoking cessation program called SMS (Stop My Smoking) USA. It will be tailored for the unique needs and smoking habits of young adults. The investigators hypothesize that those in the SMS USA intervention will be significantly more likely to be quit at 6-months compared to the attention-matched control group.


Description:

About one in four young adults are current smokers. Although over half report the desire to quit or cut down, quit rates in this age group have remained stagnant in the last ten years. Text messaging may represent a compelling intervention delivery method for smoking cessation for young adults because it is a medium they have widely adopted. Cell phone interventions also are unique because of their 'always on' capability - interventions are never far from the young adult's reach and they are received automatically instead of requiring the participant to initiate contact in order to receive the information. Dr. Ybarra, along with Drs. Holtrop and Graham, have developed SMS Turkey, an innovative behavioral intervention that uses text messaging to deliver CBT-based smoking cessation information to participants daily. Successful use of text messaging to deliver smoking cessation programs has been reported by Rodgers and colleagues in New Zealand and a replication study they are leading in the UK. These data provide optimism for the feasibility of text messaging-based smoking cessation programs in the United States. Using qualitative methods to inform design and content, and quantitative methods to assess the feasibility of the program, we propose to design and test SMS (Stop My Smoking) USA, a cell-phone based smoking cessation program for young adults ages 18-25. This innovative smoking cessation program uses technology widely adopted by young adults, an under-targeted population, to deliver a proactive, cognitive behavioral therapy (CBT)-based intervention. Our multidisciplinary team of researchers brings together expertise in Internet health and the design of tailored smoking cessation interventions.


Recruitment information / eligibility

Status Completed
Enrollment 164
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- 28 cigarettes or more per week (at least 4/day) and on at least 6 days/week.

- Owning a text-capable cell phone and cognizant of how to send and receive text messages

- Currently enrolled or intending to enroll in an unlimited text messaging plan

- Enrolled with a major cell phone carrier

- Agree to verification of smoking cessation status by a significant other

- Able to read and write in English

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
SMS (Stop my Smoking) USA
Intervention participants receive text messages daily pre-and post-quit. Everyone receives messages 14 days prior to the Quit day, and through the day after Quit. Then, participants are 'pathed' to particular messages based upon their self-reported smoking status at Day 2 and Day 7 post quit, respectively. Those who are successful at quitting receive messages aimed at relapse prevention whereas those who have slipped receive messages aimed at getting the person to recommit to quitting and trying again.

Locations

Country Name City State
United States Internet Solutions for Kids, Inc. Santa Ana California

Sponsors (4)

Lead Sponsor Collaborator
Center for Innovative Public Health Research Michigan State University, National Cancer Institute (NCI), The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Continuous abstinence We will measure continuous abstinence as 5 or fewer cigarettes smoked since one's quit date: "Have you smoked at all, even just a puff, since [insert quit date]?" If yes, the respondent will be probed for how many cigarettes were smoked. Responses will be categorized into one of three options: A) No, not a puff; B) 1-5 cigarettes; C) More than 5 cigarettes. Abstinence will be defined by smoking five or fewer cigarettes. 3-months post-quit No
Secondary Point prevalence A cigarette, even just a puff, within the last 7 days (yes/no) Past 7 days No
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