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

Study Overview
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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.

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

Conditions
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Smoking Cessation

Intervention / Treatment
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* Other: Treatment As Usual (TAU)
* Drug: Nicotine Replacement Therapies
* Behavioral: Text Message Intervention (TMI)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment As Usual (TAU)<br>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)<br>* 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)<br>|
| Active Comparator: Nicotine Replacement Therapies<br>Participants will receive a prescription for a nicotine replacement therapy (NRT) for 7 Days. | Drug: Nicotine Replacement Therapies<br>* 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)<br>|
| Active Comparator: Text Message Intervention<br>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)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cigarettes, smoking, opiate-dependence, alcohol, detoxification