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Bupropion for Hospital-Based Smoking Cessation

2008年5月22日 更新者:University of California, San Francisco
This is a randomized blinded trial of whether hospitalized smokers who are randomly assigned to receive bupropion, an antidepressant, and cognitive-behavioral counseling, are more likely to have quit smoking at the end of treatment and at 6 months compared with smokers randomly assigned to receive placebo and cognitive-behavioral counseling. Because depression is more prevalent among smokers and because smokers who are prone to depression may become depressed when they quit, the hypothesis is that the proportion of quitters who receive the active drug/antidepressant will be greater than the proportion of quitters who receive the placebo drug at 6 months.

研究概览

地位

完全的

条件

详细说明

Two hundred and seventy patients will be enrolled;approximately 135 will be randomized to each study arm over the course of 24 months. Patients will be considered smokers if they have used tobacco products during the week prior to admission and if they have smoked> or = 5 cigarettes /day during the previous year.Smokers will be identified by review of admissions and given a flyer to invite them to join the study. Interested smokers will be screened and asked to fill out a Beck Depression Inventory. Patients with very high Beck Depression Inventory Scores, i.e. > or = 30, will not be enrolled because such individuals may require other treatment. Each patient's physician will be contacted to verify his/her eligibility for the study. Once eligibility has been ascertained, a research associate will visit the patient to obtain informed consent and to enroll them in the study. Study questionnaires and a Fagerstrom test for Nicotine Dependence will be completed and reviewed by a research associate for completeness at the time of enrollment. The associate will put in the prescription for the study drug and request the order for dispensing of the drug. The research pharmacist will randomize the patient to Study Arm 1 or Study Arm 2.

Subjects randomized to Study Arm 1 will receive a standard 7-week course of sustained release bupropion (150 mg/day for the first 3 days, then 150mg BID), a self-help booklet, counseling on smoking cessation strategies, and follow-up phone counseling during the first 3 months after randomization. Study Arm 2 participants will receive the same intervention as Study Arm 1, but will receive placebo instead of active bupropion therapy. Both study groups will complete study questionnaires regarding their medical and smoking history and will be followed one week after their hospital discharge to record their blood pressure and to monitor possible side effects.

Since quit rates tend to decline over time, relapse prevention approaches will be included in both study arms. Marlatt's theory of relapse, an extension of Bandura's social learning model, will be used to augment the quitter's perception of self-efficacy. Participants will be trained to resist and cope with the temptations and stresses likely to be encountered after discharge from the hospital. Behavioral self-management techniques to counter known relapse-triggers such as stress, the presence of other smokers, alcohol use and depression will be discussed during follow-up counseling calls.

We will measure saliva cotinine in all participants who give a history of smoking abstinence at the end of treatment and at 6 months. Cotinine levels of > or + 15 ng/mL will be considered evidence of current tobacco use. Participants who are self-reported quitters, but have failed to provide a saliva sample will be considered as smokers unless verification from a spouse or significant other can be obtained. Participants who have died will be analyzed as smokers or quitters based on prior self-report, information in medical records, or interviews with next-of-kin. Others will be censored (i.e. excluded from the analysis). All cotinine samples will be assayed at the University of California, San Francisco,laboratory of Dr. Neal Benowitz.

研究类型

介入性

注册 (实际的)

85

阶段

  • 第三阶段

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

    • California
      • San Francisco、California、美国、94121
        • Veterans Affairs Medical Center

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 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • currently smoking - use of tobacco products during the week prior to hospital admission and having smoked at least 5 cigarettes /day during the past year
  • eligibility to receive medical care in a VA hospital
  • hospitalization for at least 48 hours to provide sufficient time to identify, screen, enroll and counsel participants
  • willingness to participate and give informed consent

Exclusion Criteria:

  • hospitalization for acute CHD syndromes
  • contraindications to the use of bupropion
  • family history of seizure disorder, history of severe head trauma, predisposition to seizures
  • unstable psychiatric disorder
  • pregnancy, lactation
  • current alcohol (defined as greater than 3 drinks/day) or drug abuse (defined as current/within last 3 months use of narcotics, heroin, cocaine, amphetamines)
  • current untreated depression (BDI score > or = 30)
  • terminal illness
  • inability to be contacted by phone

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:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:1
bupropion and behavioral counseling
150 mg daily for the first 3 days, then 150 mg twice daily for 7 weeks
其他名称:
  • 载班
安慰剂比较:2
placebo medication
1 pill daily for the first 3 days, then one pill twice daily for 7 weeks
其他名称:
  • 糖丸

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Smoking status at 6 months after enrollment
大体时间:6 months
6 months

次要结果测量

结果测量
大体时间
smoking status at end of treatment
大体时间:7 weeks
7 weeks

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。

调查人员

  • 首席研究员:Joel A Simon, MD, MPH、University of California, San Francisco

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

2003年7月1日

初级完成 (实际的)

2006年8月1日

研究完成 (实际的)

2007年2月1日

研究注册日期

首次提交

2005年12月1日

首先提交符合 QC 标准的

2005年12月1日

首次发布 (估计)

2005年12月2日

研究记录更新

最后更新发布 (估计)

2008年5月23日

上次提交的符合 QC 标准的更新

2008年5月22日

最后验证

2008年5月1日

更多信息

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.

bupropion的临床试验

3
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