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临床试验/NCT01329614
NCT01329614已完成早期 1 期

Effects of Nicotine Replacement and Repeated Cue Exposure on Cigarette Craving

Columbia University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年10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
40
试验地点
1
主要终点
Galvanic Skin Response

研究概览

简要总结

The purpose of this study is to determine whether Cue Extinction Training will reduce relapse rates in cigarette smokers using the patch to quit.

详细描述

Nicotine dependence is an important public health problem that contributes to significant morbidity and mortality in our society. Treatment efforts are hampered by high relapse rates, despite the development of somewhat effective treatment modalities, such as Nicotine Replacement Treatment (NRT). NRT, e.g. the nicotine patch, is successful in smoking cessation, compensating for nicotine withdrawal after quitting smoking.

However, relapse rates remain high even in quitters on the patch. It is thought that cravings related to smoking cues contribute to relapse in smokers on the patch who try to quit. Rational treatment approaches for nicotine dependence therefore include strategies to weaken the effect of smoking cues, e.g. cue extinction training (CET). During CET smokers are repeatedly exposed to smoking cues, in the absence of nicotine administration, and smokers report lessening of cue-induced craving (extinction). It is thought that the extinction of smoking cues will result in less control of the smoking cue over smoking behavior and lower relapse rates.

The investigators hypothesize that smoking quit rates on the patch will be higher after CET. To address our hypothesis the investigators first want to develop a proof of concept procedure that demonstrates that repeated cue exposure in the laboratory results in the lessening or 'extinction' of cue-induced craving. In addition, the investigators are interested in the contribution of nicotine withdrawal to cue-induced craving. To this end, the investigators propose to include a control group without nicotine replacement (i.e. placebo patch) that will also undergo the repeated cue exposure procedure.

This study will assess the effect of CET on subsequent craving triggered by smoking cues in cigarette-smoking volunteers. After overnight abstinence, participants will come into the lab, receive a patch (nicotine or placebo) and undergo the CET procedure and perform computer tests and fill out questionnaires.

The main goal of this project is to study the relationship between nicotine replacement, cue-extinction training and subsequent cue-induced craving. Showing the effectiveness of cue-extinction training in the proposed laboratory model will support the application of the cue-extinction procedure to improve relapse rates of nicotine replacement therapies in future clinical trials.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • A DSM-IV Diagnosis of nicotine dependence with physiological dependence. Smoke at least 15 cigarettes daily for two years.
  • Not interested in treatment.
  • Medically healthy on the basis of physical examination and medical history, vital signs, EKG and laboratory tests, with a negative pregnancy test for females.
  • Able to perform study procedures.
  • Males or females between the ages of 21-60 years.
  • Female participants agree to use an effective method of birth control during the course of the study.

排除标准

  • A DSM-IV diagnosis of abuse or dependence on alcohol or drugs other than nicotine.
  • Current Axis I diagnosis or current treatment with psychotropic medications (within last 3 months).
  • Lifetime history of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders.
  • Seeking treatment for nicotine dependence.
  • Participants on parole or probation.
  • History of significant recent violent behavior.
  • Unstable medical condition, Blood Pressure > 150/90, Pregnancy.
  • History of allergic reaction to nicotine patch.
  • Participants with significant cardiac history (i.e. angina pectoris, bypass surgery, or coronary artery disease.)

研究组 & 干预措施

Nicotine Replacement Therapy, 7mg dose

Experimental

干预措施: Cue Extinction Training (Behavioral)

Nicotine Replacement Therapy, 7mg dose

Experimental

干预措施: Nicotine Replacement Therapy (Drug)

Nicotine Replacement Therapy, 7mg dose

Experimental

干预措施: Cue Extinction Therapy (Behavioral)

Nicotine Replacement Therapy, 7mg dose

Experimental

干预措施: Progressive Muscle Relaxation (Behavioral)

Nicotine Replacement Therapy, 21mg dose

Experimental

干预措施: Cue Extinction Training (Behavioral)

Nicotine Replacement Therapy, 21mg dose

Experimental

干预措施: Nicotine Replacement Therapy (Drug)

Nicotine Replacement Therapy, 21mg dose

Experimental

干预措施: Cue Extinction Therapy (Behavioral)

Nicotine Replacement Therapy, 21mg dose

Experimental

干预措施: Progressive Muscle Relaxation (Behavioral)

Nicotine Replacement Therapy, Placebo

Placebo Comparator

干预措施: Cue Extinction Training (Behavioral)

Nicotine Replacement Therapy, Placebo

Placebo Comparator

干预措施: Cue Extinction Therapy (Behavioral)

Nicotine Replacement Therapy, Placebo

Placebo Comparator

干预措施: Progressive Muscle Relaxation (Behavioral)

Nicotine Replacement Therapy, 42mg dose

Experimental

干预措施: Cue Extinction Training (Behavioral)

Nicotine Replacement Therapy, 42mg dose

Experimental

干预措施: Nicotine Replacement Therapy (Drug)

Nicotine Replacement Therapy, 42mg dose

Experimental

干预措施: Cue Extinction Therapy (Behavioral)

Nicotine Replacement Therapy, 42mg dose

Experimental

干预措施: Progressive Muscle Relaxation (Behavioral)

结局指标

主要结局

Galvanic Skin Response

时间窗: 3 days, over the course of 4-5 weeks total.

Measurements of Galvanic Skin Response (GSR) are taken while participant is exposed to the cue. The amount of change in GSR is used to determine CET's impact on cigarette craving.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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