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临床试验/NCT02665208
NCT02665208已完成不适用

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

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
203
试验地点
1
主要终点
Clinical impact assessed using self-reported abstinence at week 1 via a text message inquiry from study

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Treatment As Usual (TAU)

Active Comparator

Participants will receive informational pamphlets and information for a 1800 quit line, and a prescription for a nicotine replacement therapy (NRT) for 7 Days

干预措施: Treatment As Usual (TAU) (Other)

Nicotine Replacement Therapies

Active Comparator

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

干预措施: Nicotine Replacement Therapies (Drug)

Text Message Intervention

Active Comparator

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.

干预措施: Text Message Intervention (TMI) (Behavioral)

结局指标

主要结局

Clinical impact assessed using self-reported abstinence at week 1 via a text message inquiry from study

时间窗: 24 Weeks

Difference in patient acceptability assessed via rates of participant adoption of TMI

时间窗: 24 Weeks

Feasibility measured by rates of retention in the TMI

时间窗: 24 Weeks

次要结局

  • Change in pattern of mobile device, computer, and internet usage.(24 Weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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