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Examining Persistence in Smokers With Schizophrenia

2019年1月15日 更新者：Marc L. Steinberg, Ph.D.、Rutgers, The State University of New Jersey
All participants will receive free weekly counseling (8- weeks) and free nicotine patches (10-weeks). They will complete assessment measures commonly used in smoking cessation studies. We hope to show that this treatment is feasible in this small pilot study before comparing it to a more established treatment in a future randomized clinical trial.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This study is a non-randomized trial of a new psychosocial treatment for smoking cessation (for smokers with schizophrenia) that is based on cognitive behavioral therapy for smoking cessation - a commonly used approach. Participants will receive free weekly counseling (8- weeks) and free nicotine patches (10-weeks). They will complete assessment measures commonly used in smoking cessation studies. We hope to show that this treatment is feasible in this small pilot study before comparing it to a more established treatment in a future randomized clinical trial.

研究类型

介入性

注册 (实际的)

27

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • New Jersey
      • New Brunswick、New Jersey、美国、08901
        • Rutgers Robert Wood Johnson Medical School

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 64年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Must be between 18 - 64 years old
  • Must indicate commitment to quitting smoking in the next 30 days
  • Must smoke at least 5 cigarettes per day for past 6-months
  • Expired breath carbon monoxide (CO) > 5 to ensure daily cigarette use
  • Must score < 8 (or <7 for women) on the Alcohol Use Disorders Identification Test
  • Must score less than 3 on the 6-month Drug Abuse Screening Test-10
  • Must provide a negative urine drug screen for cannabis, cocaine, opiates, or
  • methamphetamine (Note: Participants with a positive screen for opiates may
  • participate with proof of prescription for opiates.)
  • Must have a diagnosis of Schizophrenia or Schizoaffective Disorder on Structured Clinical Interview
  • Psychiatric illness must be stable, as indicated by no hospitalizations in previous 8 weeks, and a stable psychotropic medication regimen including a stable antipsychotic dose for 8 weeks

Exclusion Criteria:

  • Must not be currently receiving tobacco dependence treatment counseling
  • Must not currently be taking varenicline (Chantix)
  • Must not be taking bupropion (Zyban/Wellbutrin) to quit smoking
  • Must not be taking any nicotine preparations (gum, lozenge, patch, spray, inhaler) daily over the last 10 days.
  • Must not report unstable angina pectoris, myocardial infarction, or significant cardiac arrhythmia (including atrial fibrillation) in the past 90 days
  • Must not be pregnant, breastfeeding, or planning on becoming pregnant in the next 4-months. Women who can become pregnant may be included if using effective birth control
  • Must not have pending legal matters with potential to result in jail time
  • Must not be planning on moving outside local area in next 3-months

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Persistence Targeted Smoking Cessation
8 weekly counseling sessions + 10 weeks of over-the-counter nicotine patch
行为的：counseling
individual, weekly, smoking cessation counseling + over-the-counter nicotine patch

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Task Persistence - Mirror Tracing
大体时间：Through end-of-treatment - approximately 8 weeks after baseline
Number of seconds persisting on a computerized mirror tracing task (Higher number of seconds = greater persistence)
Through end-of-treatment - approximately 8 weeks after baseline
Task Persistence - Sustained Divided Attention Task
大体时间：Through end-of-treatment - approximately 8 weeks after baseline
Seconds persisting on Sustained Divided Attention Task (Higher number of seconds = greater persistence)
Through end-of-treatment - approximately 8 weeks after baseline
Task Persistence - Breath-holding
大体时间：Through end-of-treatment - approximately 8 weeks after baseline
Number of seconds persisting on a breath-holding endurance task (Higher number of seconds = greater persistence)
Through end-of-treatment - approximately 8 weeks after baseline
Task Persistence -Temperament and Character Inventory-Persistence Scale (TCI-P)
大体时间：Through end-of-treatment - approximately 8 weeks after baseline
Score on Temperament and Character Inventory-Persistence Scale (TCI-P) (Higher score = greater persistence)
Through end-of-treatment - approximately 8 weeks after baseline
Task Persistence - 2-item Task Persistence Measure
大体时间：Through end-of-treatment - approximately 8 weeks after baseline
Score on 2-item Task Persistence Measure (Higher score = greater persistence)
Through end-of-treatment - approximately 8 weeks after baseline
Task Persistence - Distress Tolerance Scale (DTS)
大体时间：Through end-of-treatment - approximately 8 weeks after baseline
Score on Distress Tolerance Scale (DTS) (Higher score = greater persistence)
Through end-of-treatment - approximately 8 weeks after baseline
Task Persistence - Thoughts About Smoking Questionnaire
大体时间：Through end-of-treatment - approximately 8 weeks after baseline
Score on the Thoughts About Smoking Questionnaire (Higher score = less persistence)
Through end-of-treatment - approximately 8 weeks after baseline
Self-reported ratings of ease of understanding and helpfulness of counseling
大体时间：Through end-of-treatment - approximately 8 weeks after baseline
percentage of participants who rate the intervention as "easy to understand" and "helpful"
Through end-of-treatment - approximately 8 weeks after baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Rutgers, The State University of New Jersey

合作者

National Institute on Drug Abuse (NIDA)

调查人员

  • 首席研究员：Marc L Steinberg, Ph.D.、Rutgers, The State University of New Jersey

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年1月1日

初级完成 (实际的)

2018年6月13日

研究完成 (实际的)

2018年6月13日

研究注册日期

首次提交

2017年11月3日

首先提交符合 QC 标准的

2017年11月14日

首次发布 (实际的)

2017年11月17日

研究记录更新

最后更新发布 (实际的)

2019年1月17日

上次提交的符合 QC 标准的更新

2019年1月15日

最后验证

2019年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 20150001885
  • R21DA041163-01 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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