Smoking CessationNCT02665208
A Pilot Text Messaging Intervention to Reduce Smoking in Office-based Buprenorphine and Inpatient Detoxification Patients
A study testing Treatment As Usual (TAU), Nicotine Replacement Therapies and Text Message Intervention (TMI) in people with Smoking Cessation, run by NYU Langone Health at 1 site in United States.
Trial summary
The primary purpose of this study is to understand the feasibility of a text messaging intervention developed by the National Cancer Institute, known as Smokefreetxt, to improve smoking cessation among opiate and/or alcohol dependent participants discharged from an inpatient detoxification unit and enrolled in an… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Treatment As Usual (TAU), Nicotine Replacement Therapies and Text Message Intervention (TMI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Sep 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-described every or some day smoker
- diagnosed with opiate dependence and/or alcohol dependence (DSM-IV) per Physician medical records (MISYS)
- Fluency in English and able to provide a written informed consent
- Currently owning a mobile phone with a working phone number
- Expected to reside in the New York City area for the next 12 months
- Understands and able to respond to the intervention text message
Who cannot join
- inability to read or understand English
- currently using nicotine replacement therapies (patch, gum, e-cigarettes), pharmacotherapy for smoking cessation such as bupropion (zyban, wellbutrin), varenicline (Chantix).
- suicidal or homicidal ideations
- any ongoing psychotic disorder, life-threatening medical or psychiatric condition
- leaves the inpatient detoxification unit prior to completing study enrollment
- is pregnant, nursing or planning to conceive within the duration of the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Mobile Phone Messaging to Support Smoking Cessation Among Office-based Buprenorphine and Inpatient Detoxification Patients: a Pilot Study
The primary purpose of this study is to understand the feasibility of a text messaging intervention developed by the National Cancer Institute, known as Smokefreetxt, to improve smoking cessation among opiate and/or alcohol dependent participants discharged from an inpatient detoxification unit and enrolled in an office-based buprenorphine program patients (OBBP). Participants will be randomized to 1) treatment as usual (TAU) comprised of informational pamphlets and information for a 1800 quit line; and a prescription for a nicotine replacement therapy (NRT) (i.e. nicotine replacement patches based on the quantity of baseline self-reported smoking, or nicotine replacement gum (2mg) #10, for 28 days which is offered routinely to all inpatients at Bellevue at the time of discharge) versus the SmokeFreeTXT intervention plus prescriptions for NRT.
- Conditions
- Smoking Cessation
- Being tested
- Treatment As Usual (TAU), Nicotine Replacement Therapies, Text Message Intervention (TMI)
- Keywords
- cigarettes, smoking, opiate-dependence, alcohol, detoxification
- Medical subject headings
- Smoking Cessation, Smoking, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment As Usual (TAU)Other
informational pamphlets and information from 1800 quit line + prescription for nicotine replacement therapy (NRT) based on on the quantity of baseline self-reported smoking, or nicotine replacement gum (2mg)
Nicotine Replacement TherapiesDrug
a prescription for a nicotine replacement therapy (NRT) (i.e. nicotine replacement patches based on the quantity of baseline self-reported smoking, or nicotine replacement gum (2mg)
Text Message Intervention (TMI)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual (TAU) | Active comparator | Participants will receive informational pamphlets and information for a 1800 quit line, and a prescription for a nicotine replacement therapy (NRT) for 7 Days Receives: Other: Treatment As Usual (TAU) |
| Nicotine Replacement Therapies | Active comparator | Participants will receive a prescription for a nicotine replacement therapy (NRT) for 7 Days. Receives: Drug: Nicotine Replacement Therapies |
| Text Message Intervention | Active comparator | Participants will receive up to 5 messages a day with message content informed by principles of cognitive behavioral therapy using software developed and maintained by the National Cancer Institute. Receives: Behavioral: Text Message Intervention (TMI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in patient acceptability assessed via rates of participant adoption of TMI
Measured: 24 Weeks
Feasibility measured by rates of retention in the TMI
Measured: 24 Weeks
Clinical impact assessed using self-reported abstinence at week 1 via a text message inquiry from study
Measured: 24 Weeks
Secondary outcomes (1)
Change in pattern of mobile device, computer, and internet usage.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startMar 2015
- Primary completionSep 2015
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Babak Tofighi, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665208
- Sponsor's protocol ID
- 14-01654
- Status last verified
- Dec 2017
- First submitted
- 20 Jan 2016
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Phone Messaging to Support Smoking Cessation Among Office-based Buprenorphine and Inpatient Detoxification Patients: a Pilot Study
- ClinicalTrials.gov ID
- NCT02665208
- Acronym / sponsor ID
- 14-01654
- Conditions
- Smoking Cessation
- Keywords
- cigarettes, smoking, opiate-dependence, alcohol, detoxification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 27 Jan 2016 (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 purpose of this study is to understand the feasibility of a text messaging intervention developed by the National Cancer Institute, known as Smokefreetxt, to improve smoking cessation among opiate and/or alcohol dependent participants discharged from an inpatient detoxification unit and enrolled in an office-based buprenorphine program patients (OBBP). Participants will be randomized to 1) treatment as usual (TAU) comprised of informational pamphlets and information for a 1800 quit line; and a prescription for a nicotine replacement therapy (NRT) (i.e. nicotine replacement patches based on the quantity of baseline self-reported smoking, or nicotine replacement gum (2mg) #10, for 28 days which is offered routinely to all inpatients at Bellevue at the time of discharge) versus the SmokeFreeTXT intervention plus prescriptions for NRT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual (TAU) | Active comparator | Other: Treatment As Usual (TAU)Participants will receive informational pamphlets and information for a 1800 quit line, and a prescription for a nicotine replacement therapy (NRT) for 7 Days |
| Nicotine Replacement Therapies | Active comparator | Drug: Nicotine Replacement TherapiesParticipants will receive a prescription for a nicotine replacement therapy (NRT) for 7 Days. |
| Text Message Intervention | Active comparator | Behavioral: Text Message Intervention (TMI)Participants will receive up to 5 messages a day with message content informed by principles of cognitive behavioral therapy using software developed and maintained by the National Cancer Institute. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- self-described every or some day smoker
- diagnosed with opiate dependence and/or alcohol dependence (DSM-IV) per Physician medical records (MISYS)
- Fluency in English and able to provide a written informed consent
- Currently owning a mobile phone with a working phone number
- Expected to reside in the New York City area for the next 12 months
Key exclusion criteria (6 listed)
- inability to read or understand English
- currently using nicotine replacement therapies (patch, gum, e-cigarettes), pharmacotherapy for smoking cessation such as bupropion (zyban, wellbutrin), varenicline (Chantix).
- suicidal or homicidal ideations
- any ongoing psychotic disorder, life-threatening medical or psychiatric condition
- leaves the inpatient detoxification unit prior to completing study enrollment
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 |
|---|---|---|
| Treatment As Usual (TAU)informational pamphlets and information from 1800 quit line + prescription for nicotine replacement therapy (NRT) based on on the quantity of baseline self-reported smoking, or nicotine replacement gum (2mg) | Other | Treatment As Usual (TAU) |
| Nicotine Replacement Therapiesa prescription for a nicotine replacement therapy (NRT) (i.e. nicotine replacement patches based on the quantity of baseline self-reported smoking, or nicotine replacement gum (2mg) | Drug | Nicotine Replacement Therapies |
| Text Message Intervention (TMI) | Behavioural | Text Message Intervention |
Primary outcome
Difference in patient acceptability assessed via rates of participant adoption of TMI
Time frame: 24 Weeks
Feasibility measured by rates of retention in the TMI
Time frame: 24 Weeks
Clinical impact assessed using self-reported abstinence at week 1 via a text message inquiry from study
Time frame: 24 Weeks
1 secondary outcome
Change in pattern of mobile device, computer, and internet usage.
Time frame: 24 Weeks
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 6 Dec 2017.
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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.
Babak Tofighi, MD principal investigator
New York University 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 Treatment As Usual (TAU), Nicotine Replacement Therapies and Text Message Intervention (TMI) in people with Smoking Cessation, run by NYU Langone Health 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 6 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 6 Dec 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. 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?
Difference in patient acceptability assessed via rates of participant adoption of TMI (time frame: 24 Weeks). The study lists 3 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 6 Dec 2017; AzTrials last refreshed its copy on 1 Nov 2026.