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

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: Nicotine Replacement Therapies; Other: Treatment As Usual (TAU); Behavioral: Text Message Intervention (TMI)

• Registration Number: NCT02665208
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2015-09
• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-27
• Study Completion: 2017-09
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotine Replacement Therapies	Nicotine Replacement Therapies	Participants will receive a prescription for a nicotine replacement therapy (NRT) for 7 Days.
Treatment As Usual (TAU)	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
Text Message Intervention	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.

Primary Outcome Measures

Name	Time	Method
Clinical impact assessed using self-reported abstinence at week 1 via a text message inquiry from study	24 Weeks
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

Secondary Outcome Measures

Name	Time	Method
Change in pattern of mobile device, computer, and internet usage.	24 Weeks

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States