Cigarette Smoking
Conditions
Keywords
cigarette smoking, tobacco use cessation products
Brief summary
This study is a randomized-controlled clinical trial which evaluates the efficacy of physician brief advice, nicotine replacement therapy and a 6-week course of text messaging in promoting cigarette smoking in smokers enrolled in college. The primary hypothesis is that smokers receiving physician brief advice, nicotine replacement therapy, and text messaging will have higher quit rates that smokers receiving physician brief advice and nicotine replacement therapy alone.
Interventions
Sponsors
Southern Connecticut State University
University of New Haven
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 18 through 24 years * Enrolled as a full/part time college student * A current smoker (Have smoked more than 100 cigarettes in their lifetime and now smoke every day or some days) * English-speaking * Interested in quitting * Have a cell phone for personal use with an unlimited text messaging plan.
Exclusion criteria
* History of hypersensitivity/allergy to nicotine patch; * Serious arrhythmias - History of heart disease (myocardial infarction, severe chest pain, or coronary artery disease) * Current pregnancy/breastfeeding/plan for pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Enrollment- Number of Participants Who Join the Study | baseline | We will report the number of persons who join the study. |
| Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits. | 6- and 12- weeks | We will determine the number of enrolled participants who follow up at the 6- and 12- week follow up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Abstinence | 6- and 12- weeks | biochemically confirmed point prevalence of self reported past 7-day abstinence |
Countries
United States
Participant flow
Recruitment details
Recruitment open from January 2015 to May 2016. Recruited from local college campuses.
Participants by arm
| Arm | Count |
|---|---|
| Text Messaging Smoking counseling, nicotine patch, text messaging
Smoking counseling
Text messaging
Nicotine patch | 20 |
| Standard of Care Smoking counseling, nicotine patch
Smoking counseling
Nicotine patch | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Text Messaging | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 19.9 years STANDARD_DEVIATION 1.7 | 20.5 years STANDARD_DEVIATION 1.5 | 20.2 years STANDARD_DEVIATION 1.6 |
| Race/Ethnicity, Customized Race American Indian/Alaskan Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race White | 17 Participants | 19 Participants | 36 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 13 Participants | 9 Participants | 22 Participants |
| Sex: Female, Male Male | 7 Participants | 11 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Study Enrollment- Number of Participants Who Join the Study
We will report the number of persons who join the study.
Time frame: baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Text Messaging | Study Enrollment- Number of Participants Who Join the Study | 20 Participants |
| Standard of Care | Study Enrollment- Number of Participants Who Join the Study | 20 Participants |
Primary
Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits.
We will determine the number of enrolled participants who follow up at the 6- and 12- week follow up visit.
Time frame: 6- and 12- weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Text Messaging | Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits. | 6-week retention | 19 Participants |
| Text Messaging | Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits. | 12-week retention | 19 Participants |
| Standard of Care | Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits. | 6-week retention | 20 Participants |
| Standard of Care | Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits. | 12-week retention | 18 Participants |
Secondary
Smoking Abstinence
biochemically confirmed point prevalence of self reported past 7-day abstinence
Time frame: 6- and 12- weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Text Messaging | Smoking Abstinence | 6-week | 3 Participants |
| Text Messaging | Smoking Abstinence | 12-week | 1 Participants |
| Standard of Care | Smoking Abstinence | 6-week | 5 Participants |
| Standard of Care | Smoking Abstinence | 12-week | 1 Participants |