SmokingPhase 1NCT02081144
Texting to Promote Tobacco Abstinence in Emergency Department Smokers: A Pilot Study
A Phase 1 study testing Smokefree TXT Program, nicotine replacement patches and Nicotine Replacement Gum in people with Smoking and Tobacco Abstinence, run by Yale University at 1 site in United States.
Trial summary
This is a pilot study to test the feasibility of conducting a text based smoking cessation trial with Emergency Department patients who are smokers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Tobacco Abstinence
- What is being tested?
- Smokefree TXT Program, nicotine replacement patches and Nicotine Replacement Gum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Oct 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- have smoked >= 100 cigarettes lifetime
- describe themselves as every or some day smokers
- are able to give written informed consent
- reside in Connecticut
- own a cell phone with texting capability.
Who cannot join
- inability to read or understand English
- currently receiving formal tobacco dependence treatment
- current use of tobacco cessation products (patch, gum, inhaler, nasal spray, lozenge, e-cigarette)
- currently using Zyban (bupropion), Wellbutrin (bupropion) or Chantix (varenicline) for smoking cessation
- current suicide or homicide risk
- current psychotic disorder
Show all 13Show fewer
- life-threatening or unstable medical or psychiatric condition
- does not have phone with CT area code and with texting capability
- lacks capacity to give informed consent
- leaving the ED against medical advice
- pregnant, nursing, or trying to conceive
- incarcerated
- resides in an extended care facility
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
This is a pilot study to test the feasibility of conducting a text based smoking cessation trial with Emergency Department patients who are smokers.
- Conditions
- Smoking, Tobacco Abstinence
- Being tested
- Smokefree TXT Program, nicotine replacement patches, Nicotine Replacement Gum, Faxed Referral CT Smokers Quitline
- Keywords
- Standard Care Condition, Texting + NRT Condition
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smokefree TXT ProgramOther
The SmokeFreeTxt program is a library consisting of ~130 brief messages that can be proactively sent to smokers' cellphones using software developed and maintained by NCI. The message content is informed by principles of cognitive behavioral therapy. They are sent to smokers at random times of day (during normal waking hours), up to 5 messages per day.
nicotine replacement patchesDrug
Subject will be given 4 weeks of Nicotine Replacement Patches, based on the amount he/she is smoking at baseline.
Nicotine Replacement GumDrug
Subjects will be given 10 pieces of 2mg Nicotine Replacement Gum x 28 days.
Faxed Referral CT Smokers QuitlineBehavioural
A faxed referral will be sent to the CT Smokers Quitline for the subject.
| Study group | Role | What they receive |
|---|---|---|
| Control Condition | No intervention | Control or Standard Care condition. No intervention will be provided. |
| Texting + NRT Condition | Experimental | Enrollment in NCI's Smokefree TXT Program 4 weeks of Nicotine Replacement Patches 4 weeks of Nicotine Replacement Gum Faxed Referral CT Smokers Quitline Receives: Other: Smokefree TXT Program; Drug: nicotine replacement patches; Drug: Nicotine Replacement Gum; Behavioral: Faxed Referral CT Smokers Quitline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey of satisfaction and usage of Smokefree TXT Program
Study team will develop a survey to assess both subjects' satisfaction with the Smokefree TXT Program and ease of use.
Measured: 1 month post enrollment
Secondary outcomes (1)
7 day point prevalence abstinence
7 day point prevalence abstinence will be assessed by asking if the subject has smoked even a puff in the past 7 days.
Measured: 1 month post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Steven L Bernstein, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081144
- Sponsor's protocol ID
- 1401013302
- Other IDs
- R01CA141479
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2014
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Texting to Promote Tobacco Abstinence in Emergency Department Smokers: A Pilot Study
- ClinicalTrials.gov ID
- NCT02081144
- Acronym / sponsor ID
- 1401013302
- Conditions
- Smoking, Tobacco Abstinence
- Keywords
- Standard Care Condition, Texting + NRT Condition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- May 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to test the feasibility of conducting a text based smoking cessation trial with Emergency Department patients who are smokers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Condition | No intervention | –Control or Standard Care condition. No intervention will be provided. |
| Texting + NRT Condition | Experimental | Other: Smokefree TXT Program, Drug: nicotine replacement patches, Drug: Nicotine Replacement Gum, Behavioral: Faxed Referral CT Smokers QuitlineEnrollment in NCI's Smokefree TXT Program 4 weeks of Nicotine Replacement Patches 4 weeks of Nicotine Replacement Gum Faxed Referral CT Smokers Quitline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- have smoked >= 100 cigarettes lifetime
- describe themselves as every or some day smokers
- are able to give written informed consent
- reside in Connecticut
Key exclusion criteria (13 listed)
- inability to read or understand English
- currently receiving formal tobacco dependence treatment
- current use of tobacco cessation products (patch, gum, inhaler, nasal spray, lozenge, e-cigarette)
- currently using Zyban (bupropion), Wellbutrin (bupropion) or Chantix (varenicline) for smoking cessation
- current suicide or homicide risk
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 |
|---|---|---|
| Smokefree TXT ProgramThe SmokeFreeTxt program is a library consisting of ~130 brief messages that can be proactively sent to smokers' cellphones using software developed and maintained by NCI. The message content is informed by principles of cognitive behavioral therapy. They are sent to smokers at random times of day (during normal waking hours), up to 5 messages per day. | Other | Texting + NRT Condition |
| nicotine replacement patchesSubject will be given 4 weeks of Nicotine Replacement Patches, based on the amount he/she is smoking at baseline. | Drug | Texting + NRT Condition |
| Nicotine Replacement GumSubjects will be given 10 pieces of 2mg Nicotine Replacement Gum x 28 days. | Drug | Texting + NRT Condition |
| Faxed Referral CT Smokers QuitlineA faxed referral will be sent to the CT Smokers Quitline for the subject. | Behavioural | Texting + NRT Condition |
Primary outcome
Survey of satisfaction and usage of Smokefree TXT Program
Time frame: 1 month post enrollment
Study team will develop a survey to assess both subjects' satisfaction with the Smokefree TXT Program and ease of use.
1 secondary outcome
7 day point prevalence abstinence
Time frame: 1 month post enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
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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.
Steven L Bernstein, 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 Phase 1 study testing Smokefree TXT Program, nicotine replacement patches and Nicotine Replacement Gum in people with Smoking and Tobacco Abstinence, 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 13 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 5 Mar 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survey of satisfaction and usage of Smokefree TXT Program (time frame: 1 month post enrollment). 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 5 Mar 2020.