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

Smoking Cessation Clinical Trial

Official title:

Mobile Phone Messaging to Support Smoking Cessation Among Office-based Buprenorphine and Inpatient Detoxification Patients: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665208
• Other study ID #: 14-01654
• Status: Completed
• Phase: N/A
• First received: January 20, 2016
• Last updated: December 4, 2017
• Start date: March 2015
• Est. completion date: September 2017

Study information

• Verified date: December 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: September 2017
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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)

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)

Behavioral:
• Text Message Intervention (TMI)

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in patient acceptability assessed via rates of participant adoption of TMI		24 Weeks
Primary	Feasibility measured by rates of retention in the TMI		24 Weeks
Primary	Clinical impact assessed using self-reported abstinence at week 1 via a text message inquiry from study		24 Weeks
Secondary	Change in pattern of mobile device, computer, and internet usage.		24 Weeks