Tobacco Use DisorderNCT01166464
Examining a Text Message Intervention for Smoking Cessation
A study testing text messaging for smoking cessation and Generic text messages in people with Tobacco Use Disorder and Nicotine Dependence, run by The Miriam Hospital at 1 site in United States.
Trial summary
The primary goal of this study is to use qualitative interviews and focus groups to aid us in adapting a face-to-face smoking cessation intervention for delivery through text messaging. After design is completed, the intervention will be pilot tested with a sample of young adults (ages 18-35) who smoke. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Nicotine Dependence
- What is being tested?
- text messaging for smoking cessation and Generic text messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Oct 2012
- Phase
- Interventional
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 35
- Current daily smoker
- Has a cell phone with text messaging capability
- Uses text messaging at least once monthly
- Interested in quitting smoking
- Willing to set a quit date within the next 30 days
- Has access to a physician
Who cannot join
- Does not read and speak English with adequate comprehension
- Is currently participating in a smoking cessation program
- Concurrent drug/alcohol abuse
- Mental health issues that would interfere with study compliance
Trial locations and contacts
1 site in 1 country.
About this study
The primary goal of this study is to use qualitative interviews and focus groups to aid us in adapting a face-to-face smoking cessation intervention for delivery through text messaging. After design is completed, the intervention will be pilot tested with a sample of young adults (ages 18-35) who smoke. Final assessments will be conducted at 7 weeks (end of treatment) and both 3 and 6 month follow up.
- Conditions
- Tobacco Use Disorder, Nicotine Dependence
- Being tested
- text messaging for smoking cessation, Generic text messages
- Keywords
- tobacco, smoking, text message, therapy
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
text messaging for smoking cessationBehavioural
A 7-week program of daily text messages
Generic text messagesBehavioural
non-smoking related text messages will be given on the same daily schedule as matches the active intervention to establish a control for contact time.
| Study group | Role | What they receive |
|---|---|---|
| Text Messaging | Experimental | A text message-based intervention for smoking cessation Receives: Behavioral: text messaging for smoking cessation |
| Control | Placebo comparator | Individuals in this group will receive generic (non-smoking related) text messages on the same schedule as the intervention arm. This provides a control for staff/program contact time and participant burden. Receives: Behavioral: Generic text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking abstinence
7-day point prevalence abstinence will be measured at 6 months post-treatment.
Measured: Six months post-treatment
Secondary outcomes (1)
Usability and Acceptability of the intervention
Usability and acceptability of the intervention will be assessed at the end of treatment (week 7).
Measured: 7 weeks (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startJul 2009
- Primary completionApr 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies 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
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Live Inspired, LLC
- Responsible party
- Principal investigator, Beth Bock, Ph.D., The Miriam Hospital
- Investigators
- Beth C Bock, PhD, Principal investigator, The Miriam Hospital, Brown Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166464
- Sponsor's protocol ID
- R21DA027142
- Status last verified
- Jan 2014
- First submitted
- 16 Jul 2010
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bock B, Heron K, Jennings E, Morrow K, Cobb V, Magee J, Fava J, Deutsch C, Foster R. A Text Message Delivered Smoking Cessation Intervention: The Initial Trial of TXT-2-Quit: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2013 Jul 30;1(2):e17. doi: 10.2196/mhealth.2522.
PubMed 25098502
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining a Text Message Intervention for Smoking Cessation
- ClinicalTrials.gov ID
- NCT01166464
- Acronym / sponsor ID
- R21DA027142
- Conditions
- Tobacco Use Disorder, Nicotine Dependence
- Keywords
- tobacco, smoking, text message, therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- Live Inspired, LLC
- Study start
- Jul 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 21 Jul 2010 (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.
The primary goal of this study is to use qualitative interviews and focus groups to aid us in adapting a face-to-face smoking cessation intervention for delivery through text messaging. After design is completed, the intervention will be pilot tested with a sample of young adults (ages 18-35) who smoke. Final assessments will be conducted at 7 weeks (end of treatment) and both 3 and 6 month follow up.
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: text messaging for smoking cessationA text message-based intervention for smoking cessation |
| Control | Placebo comparator | Behavioral: Generic text messagesIndividuals in this group will receive generic (non-smoking related) text messages on the same schedule as the intervention arm. This provides a control for staff/program contact time and participant burden. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18 to 35
- Current daily smoker
- Has a cell phone with text messaging capability
- Uses text messaging at least once monthly
- Interested in quitting smoking
Key exclusion criteria (4 listed)
- Does not read and speak English with adequate comprehension
- Is currently participating in a smoking cessation program
- Concurrent drug/alcohol abuse
- Mental health issues that would interfere with study compliance
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 |
|---|---|---|
| text messaging for smoking cessationA 7-week program of daily text messages | Behavioural | Text Messaging |
| Generic text messagesnon-smoking related text messages will be given on the same daily schedule as matches the active intervention to establish a control for contact time. | Behavioural | Control |
Primary outcome
Smoking abstinence
Time frame: Six months post-treatment
7-day point prevalence abstinence will be measured at 6 months post-treatment.
1 secondary outcome
Usability and Acceptability of the intervention
Time frame: 7 weeks (end of treatment)
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 3 Feb 2014.
- Derived from this study: PubMed 25098502Bock B, Heron K, Jennings E, Morrow K, Cobb V, Magee J, Fava J, Deutsch C, Foster R. A Text Message Delivered Smoking Cessation Intervention: The Initial Trial of TXT-2-Quit: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2013 Jul 30;1(2):e17. doi: 10.2196/mhealth.2522.
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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.
Beth C Bock, PhD principal investigator
The Miriam Hospital, Brown Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing text messaging for smoking cessation and Generic text messages in people with Tobacco Use Disorder and Nicotine Dependence, run by The Miriam Hospital 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 7 inclusion and 4 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 3 Feb 2014. 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?
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?
Smoking abstinence (time frame: Six months post-treatment). 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 NCT01166464, 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 3 Feb 2014.