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

NCT ID: NCT02665208

Last Updated: 2017-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-09-30

Brief Summary

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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

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Conditions

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Smoking Cessation

Keywords

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cigarettes smoking opiate-dependence alcohol detoxification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Treatment As Usual (TAU)

Intervention Type OTHER

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)

Nicotine Replacement Therapies

Participants will receive a prescription for a nicotine replacement therapy (NRT) for 7 Days.

Group Type ACTIVE_COMPARATOR

Nicotine Replacement Therapies

Intervention Type DRUG

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)

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.

Group Type ACTIVE_COMPARATOR

Text Message Intervention (TMI)

Intervention Type BEHAVIORAL

Interventions

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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)

Intervention Type OTHER

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)

Intervention Type DRUG

Text Message Intervention (TMI)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Babak Tofighi, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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14-01654

Identifier Type: -

Identifier Source: org_study_id