Cigarette SmokingNCT02191033
Text Messaging for Smoking Cessation in College Health Clinics
A study testing Smoking counseling, Text messaging and Nicotine patch in people with Cigarette Smoking, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Smoking counseling, Text messaging and Nicotine patch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Connecticut State University
New Haven, Connecticut, 06515
About this study
Official title: Text Messaging to Augment Physician Brief Advice for Smoking Cessation in College Health Clinics
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.
- Conditions
- Cigarette Smoking
- Being tested
- Smoking counseling, Text messaging, Nicotine patch
- Keywords
- cigarette smoking, tobacco use cessation products
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking counselingBehavioural
Text messagingBehavioural
Nicotine patchDrug
| Study group | Role | What they receive |
|---|---|---|
| Text messaging | Experimental | Smoking counseling, nicotine patch, text messaging Receives: Behavioral: Smoking counseling; Behavioral: Text messaging; Drug: Nicotine patch |
| Standard of care | Active comparator | Smoking counseling, nicotine patch Receives: Behavioral: Smoking counseling; Drug: Nicotine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Enrollment- Number of Participants Who Join the Study
We will report the number of persons who join the study.
Measured: baseline
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.
Measured: 6- and 12- weeks
Secondary outcomes (1)
Smoking Abstinence
biochemically confirmed point prevalence of self reported past 7-day abstinence
Measured: 6- and 12- weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJan 2015
- Primary completionMay 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Connecticut State University, University of New Haven
- Responsible party
- Sponsor
- Investigators
- Deepa R Camenga, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191033
- Sponsor's protocol ID
- 1404013813
- Status last verified
- Mar 2020
- First submitted
- 8 Jul 2014
- Last updated
- 1 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Messaging to Augment Physician Brief Advice for Smoking Cessation in College Health Clinics
- ClinicalTrials.gov ID
- NCT02191033
- Acronym / sponsor ID
- 1404013813
- Conditions
- Cigarette Smoking
- Keywords
- cigarette smoking, tobacco use cessation products
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Southern Connecticut State University, University of New Haven
- Study start
- Jan 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Posted 1 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text messaging | Experimental | Behavioral: Smoking counseling, Behavioral: Text messaging, Drug: Nicotine patchSmoking counseling, nicotine patch, text messaging |
| Standard of care | Active comparator | Behavioral: Smoking counseling, Drug: Nicotine patchSmoking counseling, nicotine patch |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking counseling | Behavioural | Standard of care, Text messaging |
| Text messaging | Behavioural | Text messaging |
| Nicotine patch | Drug | Standard of care, Text messaging |
Primary outcome
Study Enrollment- Number of Participants Who Join the Study
Time frame: 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.
Time frame: 6- and 12- weeks
We will determine the number of enrolled participants who follow up at the 6- and 12- week follow up visit.
1 secondary outcome
Smoking Abstinence
Time frame: 6- and 12- weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepa R Camenga, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking counseling, Text messaging and Nicotine patch in people with Cigarette Smoking, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Enrollment- Number of Participants Who Join the Study (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.