Trial Outcomes & Findings for Text Messaging for Smoking Cessation in College Health Clinics (NCT NCT02191033)

NCT ID: NCT02191033

Last Updated: 2020-04-01

Results Overview

We will report the number of persons who join the study.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: baseline
• Results posted on: 2020-04-01

Participant Flow

Recruitment open from January 2015 to May 2016. Recruited from local college campuses.

Participant milestones

Measure	Text Messaging Smoking counseling, nicotine patch, text messaging Smoking counseling Nicotine patch Text messaging	Standard of Care Smoking counseling, nicotine patch Smoking counseling Nicotine patch
Overall Study STARTED	20	20
Overall Study COMPLETED	18	19
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Text Messaging for Smoking Cessation in College Health Clinics

Baseline characteristics by cohort

Measure	Text Messaging n=20 Participants Smoking counseling, nicotine patch, text messaging Smoking counseling Text messaging Nicotine patch	Standard of Care n=20 Participants Smoking counseling, nicotine patch Smoking counseling Nicotine patch	Total n=40 Participants Total of all reporting groups
Age, Continuous	19.9 years STANDARD_DEVIATION 1.7 • n=5 Participants	20.5 years STANDARD_DEVIATION 1.5 • n=7 Participants	20.2 years STANDARD_DEVIATION 1.6 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian/Alaskan Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

We will report the number of persons who join the study.

Outcome measures

Measure	Text Messaging n=20 Participants Smoking counseling, nicotine patch, text messaging Smoking counseling Nicotine patch Text messaging	Standard of Care n=20 Participants Smoking counseling, nicotine patch Smoking counseling Nicotine patch
Study Enrollment- Number of Participants Who Join the Study	20 Participants	20 Participants

PRIMARY outcome

Timeframe: 6- and 12- weeks

We will determine the number of enrolled participants who follow up at the 6- and 12- week follow up visit.

Outcome measures

Measure	Text Messaging n=20 Participants Smoking counseling, nicotine patch, text messaging Smoking counseling Nicotine patch Text messaging	Standard of Care n=20 Participants Smoking counseling, nicotine patch Smoking counseling Nicotine patch
Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits. 6-week retention	19 Participants	20 Participants
Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits. 12-week retention	19 Participants	18 Participants

SECONDARY outcome

Timeframe: 6- and 12- weeks

biochemically confirmed point prevalence of self reported past 7-day abstinence

Outcome measures

Measure	Text Messaging n=20 Participants Smoking counseling, nicotine patch, text messaging Smoking counseling Nicotine patch Text messaging	Standard of Care n=20 Participants Smoking counseling, nicotine patch Smoking counseling Nicotine patch
Smoking Abstinence 6-week	3 Participants	5 Participants
Smoking Abstinence 12-week	1 Participants	1 Participants

Adverse Events

Text Messaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Deepa Camenga, MD

Yale University

Phone: 203-737-8310

Email: deepa.camenga@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place