Clinical trial NCT02665208: A Pilot Text Messaging Intervention to Reduce Smoking in Office-based Buprenorphine and Inpatient Detoxification Patients
Official title: Mobile Phone Messaging to Support Smoking Cessation Among Office-based Buprenorphine and Inpatient Detoxification Patients: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: cigarettes
smoking
opiate-dependence
alcohol
detoxification
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Difference in patient acceptability assessed via rates of participant adoption of TMI
timeFrame: 24 Weeks
measure: Feasibility measured by rates of retention in the TMI
timeFrame: 24 Weeks
measure: Clinical impact assessed using self-reported abstinence at week 1 via a text message inquiry from study
timeFrame: 24 Weeks
Secondary outcomes:
measure: Change in pattern of mobile device, computer, and internet usage.
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Babak Tofighi, MD
role: PRINCIPAL_INVESTIGATOR
References: