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

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 Overview

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

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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)
Active Comparator: Nicotine Replacement Therapies; Participants will receive a prescription for a nicotine replacement therapy (NRT) for 7 Days.	Drug: Nicotine 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)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Change in pattern of mobile device, computer, and internet usage.	24 Weeks

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Babak Tofighi, MD, New York University Medical School

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: January 20, 2016
• First Submitted That Met QC Criteria: January 22, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: December 4, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: alcohol; smoking; detoxification; cigarettes; opiate-dependence
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 14-01654

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No