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CompletedNCT02665208Updated Dec 6, 2017

A Pilot Text Messaging Intervention to Reduce Smoking in Office-based Buprenorphine and Inpatient Detoxification Patients

An interventional study of Treatment As Usual (TAU) and Nicotine Replacement Therapies in Smoking Cessation, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-06.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
203
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Smoking Cessation

Keywords

  • cigarettes
  • smoking
  • opiate-dependence
  • alcohol
  • detoxification
03

In context

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
203 participants (actual)

Study arms

  • Active comparator
    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

    Other: Treatment As Usual (TAU)

  • Active comparator
    Nicotine Replacement Therapies

    Participants will receive a prescription for a nicotine replacement therapy (NRT) for 7 Days.

    Drug: Nicotine Replacement Therapies

  • Active comparator
    Text Message Intervention

    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.

    Behavioral: Text Message Intervention (TMI)

Interventions

  • OtherTreatment 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)

  • DrugNicotine Replacement Therapies

    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)

  • BehavioralText Message Intervention (TMI)
06

What researchers measure

Primary outcomes

  1. Difference in patient acceptability assessed via rates of participant adoption of TMI

    Time frame: 24 Weeks

  2. Feasibility measured by rates of retention in the TMI

    Time frame: 24 Weeks

  3. Clinical impact assessed using self-reported abstinence at week 1 via a text message inquiry from study

    Time frame: 24 Weeks

Secondary outcomes

  1. Change in pattern of mobile device, computer, and internet usage.

    Time frame: 24 Weeks

07

Study locations

1 site
  • New York University School of Medicine
    New York, New York 10016, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02665208
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Jan 27, 2016
Start date
Mar 2015
Primary completion
Sep 2015
Completion
Sep 2017
Last update
Dec 6, 2017

Study contacts

Babak Tofighi, MD
principal investigator · New York University Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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