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临床试验/NCT00136838
NCT00136838已完成不适用

Effect of Smoking Exposure on Tobacco Self-Administration Following Brief Abstinence

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2001年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Cigarette Choice After 3 Day Abstinence

研究概览

简要总结

Recent research on the effects of nicotine on the brain and behavior presents an opportunity to advance medication development.

The purpose of this study is to develop a laboratory model for early-stage testing of new and existing treatments for nicotine addiction. Specifically, the investigators will develop a laboratory model of relapse to cigarette use in nicotine dependent volunteers.

详细描述

Tobacco use is the leading preventable cause of death in the United States. Recent research on the effects of nicotine on the brain and behavior presents an opportunity to advance medication development. The goal of this study is to develop a laboratory model for early-stage testing of new and existing compounds for the treatment of tobacco and nicotine addiction. In addition, the objective of this study is to develop a laboratory model of relapse induced by cigarette exposure that would reproduce the psychological and physiological processes that are involved when abstinent individuals progress from initial cigarette smoking (lapse) to a pre-abstinence level of use (relapse). Such a model may be used to study the mechanisms of relapse and to screen medications that might be effective in preventing relapse in treatment seekers.

This study will consist of two phases. Each phase will consist of a 5-day inpatient stay. During the first portion of inpatient stay, participants will not be permitted to smoke. During the second portion of inpatient stay, smoking reinstatement will be modeled, as participant will have opportunity to smoke, following the exposure to tobacco-related or control cues. A variety of behavioral, subjective, physiological, and performance measures will be assessed throughout the study.

研究设计

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

入排标准

年龄范围
21 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of nicotine dependence with psychological dependence
  • •Smokes at least 15 cigarettes per day for the three months prior to enrollment
  • •Currently not seeking treatment for nicotine dependence
  • •Medically healthy, on the basis of physical examination and medical history, vital signs, EKG, and laboratory tests
  • •Females must use an effective method of contraception for the duration of the study

排除标准

  • •Diagnosis of abuse or dependence on alcohol or drugs other than nicotine
  • •Current Axis I diagnosis or current treatment with psychotropic medications within the 3 months prior to enrollment
  • •History of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders
  • •Currently seeking treatment for nicotine disorders
  • •On parole or probation
  • •History of seizures or head trauma with loss of consciousness, brain contusion, or fracture
  • •History of significant recent violent behavior
  • •Blood pressure greater than 150/90
  • •History of eating disorders

研究组 & 干预措施

Neutral Cue first, then Active Cue

Experimental

Each participant receives two consecutive interventions.

  1. Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue
  2. Cigarette cue: during this phase of treatment participants were presented with active cigarette cue.

干预措施: Neutral or active cigarette cues (Behavioral)

Active Cue first, then Neutral Cue

Experimental

Each participant receives two consecutive interventions.

  1. Cigarette cue: during this phase of treatment participants were presented with active cigarette cue.
  2. Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue

干预措施: Neutral or active cigarette cues (Behavioral)

结局指标

主要结局

Cigarette Choice After 3 Day Abstinence

时间窗: During Day 4 experimental session

Following 3 days of abstinence participants had an option to smoke cigarettes every 30 minutes for the maximum of 6 choices

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adam Bisaga

Research Psychiatrist

New York State Psychiatric Institute

研究点 (1)

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