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临床试验/NCT00625131
NCT00625131已完成早期 1 期

Nicotine Patch Pre-treatment for Smoking Cessation in PTSD

US Department of Veterans Affairs1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
87
试验地点
1
主要终点
Smoking Abstinence, Self-reported

研究概览

简要总结

This study seeks to evaluate the relationship between PTSD, abstinence, and factors associated with relapse in the context of a randomized, clinical smoking cessation trial.

详细描述

Smokers with PTSD will be randomly assigned to 1 of 2 pre-cessation patch therapy conditions (active patch versus placebo patch) for three weeks before a target quit-smoking date. All participants to will receive bupropion beginning 1 week prior to their quit day, given that they are medically eligible to be prescribed bupropion. All participants will receive a two session brief cognitive-behavioral therapy (CBT) session and will begin standard nicotine replacement therapy (NRT) on their quit day. PTSD symptoms, mood, and smoking craving will be carefully evaluated throughout the study using electronic diary assessments on personal digital assistants (PDA). Specifically, participants will carefully monitor their symptoms, mood, craving, and use of cigarettes using electronic diaries for one week prior to the pre-cessation period, during the 3-week pre-cessation treatment period, and 6 weeks post quit date. Since no previous study has examined factors associated with smoking abstinence following treatment among PTSD smokers10, predictors of treatment response will be examined. The study is designed to address the following items:

Specific Aim 1: To evaluate whether supplemental nicotine administration (i.e., pre-cessation treatment with nicotine patch and bupropion) will result in improved quit rates among smokers with PTSD.

Hypothesis 1.1 Supplemental nicotine administration during the pre-cessation period will result in improved quit rates in the first quit week over the placebo patch condition.

Specific Aim 2: To utilize electronic diary assessment of PTSD symptoms, mood, smoking craving, and smoking during baseline, pretreatment, and quit periods to evaluate potential mechanisms of how pretreatment with the nicotine patch may increase abstinence rates.

Hypothesis 2.1 Supplemental nicotine administration will decrease craving for cigarettes during the 2 week pretreatment period as compared to the placebo patch condition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Smokers who smoke 10 or more cigarettes per day in the past year;
  • 18-80 years old;
  • English speakers;
  • medically stable;
  • stable on current medication regimen

排除标准

  • Pregnant women excluded;
  • participants with organic mental disorder, schizophrenia, bipolar disorder, lifetime but not current PTSD, current substance abuse or dependence;
  • medical conditions contraindicated with nicotine replacement therapy;
  • use other forms of nicotine (cigars, nicotine gum, etc.)

研究组 & 干预措施

Active Nicotine Patch Group

Active Comparator

Transdermal nicotine patch

干预措施: Nicotine (Drug)

Active Nicotine Patch Group

Active Comparator

Transdermal nicotine patch

干预措施: Cognitive Behavioral Therapy for Smoking Cessation (Behavioral)

Active Nicotine Patch Group

Active Comparator

Transdermal nicotine patch

干预措施: Bupropion Sustained Release (SR) (Drug)

Placebo Patch Group

Placebo Comparator

Transdermal placebo patch

干预措施: Cognitive Behavioral Therapy for Smoking Cessation (Behavioral)

Placebo Patch Group

Placebo Comparator

Transdermal placebo patch

干预措施: Bupropion Sustained Release (SR) (Drug)

Placebo Patch Group

Placebo Comparator

Transdermal placebo patch

干预措施: Placebo patch (Drug)

结局指标

主要结局

Smoking Abstinence, Self-reported

时间窗: Week prior to Session 12 at 6 weeks post-treatment

Number of participants by group reporting 1 week of self-reported abstinence in the week prior to Session 12 at six weeks post-treatment

次要结局

  • Carbon Monoxide Monitoring(Session 12 (6 weeks post-treatment))
  • Smoking Craving(Daily between visits 2-12)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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