Nicotine Dependence, CigarettesNCT02367391
Penn State TXT2Quit Study
A study testing Motivational Text Messages in people with Nicotine Dependence, Cigarettes, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This study is evaluating the feasibility and short term smoking cessation outcomes of an automated smoking cessation intervention delivered via mobile phone text messaging as an adjunct to Varenicline in a primary care setting. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Cigarettes
- What is being tested?
- Motivational Text Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Oct 2015
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smoke >4 cigarettes/day for at least 6 months
- Age 21+
- Want to quit and ready to try in next 30 days
- Willing to quit all forms of tobacco (including e-cigs)
- Willing to use Chantix to try to quit
- Have a cell phone able to receive text messages
Show all 11Show fewer
- Willing to attend 3 visits and use varenicline for smoking cessation
- Plan to live in local area for next 6 months
- Read and write in English
- Women not pregnant and taking steps to avoid
- Able to understand and willing to sign consent
Who cannot join
- History of allergic reaction or other adverse event while using varenicline
- Used a smoking cessation aid/medicine in past 1 month (including e-cigs)
- Currently pregnant or nursing
- Does not have a mobile phone that can send and receive text messages or unwilling to receive study texts
- Uncontrolled serious mental illness or substance abuse or inpatient treatment for these in the past 6 months
- Uses non-cigarette tobacco products and does not plan to quit all tobacco.
Show all 10Show fewer
- Has a history of kidney problems or receives dialysis
- Had any thoughts that they would be better off dead or of deliberate self-harm in the prior 4 weeks
- Had a heart attack in the past 4 weeks
- Mental conditions that would prohibit the participant from completing the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Pilot Randomized Trial of an Automated Smoking Cessation Intervention Via Mobile Phone Text Messages as an Adjunct to Varenicline in Primary Care
This study is evaluating the feasibility and short term smoking cessation outcomes of an automated smoking cessation intervention delivered via mobile phone text messaging as an adjunct to Varenicline in a primary care setting.
- Conditions
- Nicotine Dependence, Cigarettes
- Being tested
- Motivational Text Messages, Control
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Text MessagesBehavioural
Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
ControlBehavioural
Usual Care. All participants receive the active medication, Varenicline.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Text Messages | Experimental | Not described Receives: Behavioral: Motivational Text Messages |
| Control | Sham comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day)
Measured: 12 weeks
Sustained Abstinence at the 12-week Follow up
Measured: 12 weeks
Number of Days of Varenicline Use
Measured: 12 weeks
Number of Active Smoking Cessation Activities Used
Number of activities completed out of 6
Measured: 12 weeks
Secondary outcomes (3)
Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3.
Measured: 12 weeks
Time (in Days) to Relapse After the Target Quit Day
Measured: 12 weeks
Total Score on the Positive Smoking Cessation Activities Measure
Total score for 6 items (scored 0-3). Total score range 0-18.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2015
- Study completionOct 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine Dependence, CigarettesStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Foulds, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367391
- Sponsor's protocol ID
- 41720
- Status last verified
- May 2017
- First submitted
- 13 Feb 2015
- Last updated
- 15 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Yingst JM, Veldheer S, Hrabovsky S, Hammett E, Nicholson J, Berg A, Foulds J. Pilot Randomized Trial of an Automated Smoking Cessation Intervention via Mobile Phone Text Messages as an Adjunct to Varenicline in Primary Care. J Health Commun. 2018;23(4):370-378. doi: 10.1080/10810730.2018.1453890. Epub 2018 Mar 26.
PubMed 29578832
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Trial of an Automated Smoking Cessation Intervention Via Mobile Phone Text Messages as an Adjunct to Varenicline in Primary Care
- ClinicalTrials.gov ID
- NCT02367391
- Acronym / sponsor ID
- 41720
- Conditions
- Nicotine Dependence, Cigarettes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Posted 8 Mar 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 evaluating the feasibility and short term smoking cessation outcomes of an automated smoking cessation intervention delivered via mobile phone text messaging as an adjunct to Varenicline in a primary care setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Text Messages | Experimental | Behavioral: Motivational Text Messages |
| Control | Sham comparator | Behavioral: Control |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Smoke >4 cigarettes/day for at least 6 months
- Age 21+
- Want to quit and ready to try in next 30 days
- Willing to quit all forms of tobacco (including e-cigs)
- Willing to use Chantix to try to quit
Key exclusion criteria (10 listed)
- History of allergic reaction or other adverse event while using varenicline
- Used a smoking cessation aid/medicine in past 1 month (including e-cigs)
- Currently pregnant or nursing
- Does not have a mobile phone that can send and receive text messages or unwilling to receive study texts
- Uncontrolled serious mental illness or substance abuse or inpatient treatment for these in the past 6 months
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 |
|---|---|---|
| Motivational Text MessagesUsual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline. | Behavioural | Motivational Text Messages |
| ControlUsual Care. All participants receive the active medication, Varenicline. | Behavioural | Control |
Primary outcome
Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day)
Time frame: 12 weeks
Sustained Abstinence at the 12-week Follow up
Time frame: 12 weeks
Number of Days of Varenicline Use
Time frame: 12 weeks
Number of Active Smoking Cessation Activities Used
Time frame: 12 weeks
Number of activities completed out of 6
3 secondary outcomes
Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3.
Time frame: 12 weeks
Time (in Days) to Relapse After the Target Quit Day
Time frame: 12 weeks
Total Score on the Positive Smoking Cessation Activities Measure
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29578832Yingst JM, Veldheer S, Hrabovsky S, Hammett E, Nicholson J, Berg A, Foulds J. Pilot Randomized Trial of an Automated Smoking Cessation Intervention via Mobile Phone Text Messages as an Adjunct to Varenicline in Primary Care. J Health Commun. 2018;23(4):370-378. doi: 10.1080/10810730.2018.1453890. Epub 2018 Mar 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Text Messages in people with Nicotine Dependence, Cigarettes, run by Milton S. Hershey Medical Center 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 11 inclusion and 10 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 15 Jun 2017. 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. Some participants in this study may receive a placebo. 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 8 Mar 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?
Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day) (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02367391, which also lists 1 linked publication.
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 15 Jun 2017.