A Pilot Text Messaging Intervention to Reduce Smoking in Office-based Buprenorphine and Inpatient Detoxification Patients
Mobile Phone Messaging to Support Smoking Cessation Among Office-based Buprenorphine and Inpatient Detoxification Patients: a Pilot Study
1 other identifier
interventional
203
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 20, 2016
CompletedFirst Posted
Study publicly available on registry
January 27, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedDecember 6, 2017
December 1, 2017
6 months
January 20, 2016
December 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Difference in patient acceptability assessed via rates of participant adoption of TMI
24 Weeks
Feasibility measured by rates of retention in the TMI
24 Weeks
Clinical impact assessed using self-reported abstinence at week 1 via a text message inquiry from study
24 Weeks
Secondary Outcomes (1)
Change in pattern of mobile device, computer, and internet usage.
24 Weeks
Study Arms (3)
Treatment As Usual (TAU)
ACTIVE COMPARATORParticipants 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 COMPARATORParticipants will receive a prescription for a nicotine replacement therapy (NRT) for 7 Days.
Text Message Intervention
ACTIVE COMPARATORParticipants 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.
Interventions
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)
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Babak Tofighi, MD
New York University Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2016
First Posted
January 27, 2016
Study Start
March 1, 2015
Primary Completion
September 1, 2015
Study Completion
September 1, 2017
Last Updated
December 6, 2017
Record last verified: 2017-12