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临床试验/NCT01907594
NCT01907594撤回2 期

Effects of Nicotine Replacement Therapy and D-cycloserine on Nicotine Treatment Seekers

New York State Psychiatric Institute1 个研究点 分布在 1 个国家开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
撤回
试验地点
1
主要终点
Number of Cigarettes Smoked

研究概览

简要总结

The investigators previously developed a cigarette cue extinction treatment (CET) procedure in non-treatment seeking volunteer smokers in our nicotine laboratory. The goal of Cue Extinction Treatment is to un-pair a behavioral or autonomic response from the stimulus that triggers it. This is accomplished through repeated exposure to that trigger, while removing the patient's ability to act out the conditioned response. In the present study, the trigger is a lit cigarette, and the response the investigators seek to un-pair is cigarette craving. In the procedure the investigators have previously developed and intend to use again, the participant is shown a pack of his brand of choice cigarettes. The researcher removes a cigarette from the pack, lights it, and asks the participant to hold the cigarette without smoking it for 90 seconds. This procedure is repeated seven times over the course of a six-hour lab session. The investigators hope to boost the clinical response to smoking cue exposure therapy in quitters on NRT (nicotine replacement therapy) pretreatment by pharmacological augmentation with the partial NMDA receptor agonist D-cycloserine (DCS). Behavioral extinction training is a form of learning that may be modulated by NMDA receptor mediated glutamate transmission. The study's main hypothesis is that the partial NMDA receptor agonist D-cycloserine (DCS) facilitates cue exposure training and may prevent relapse to smoking. The aim of the proposed study is to assess whether DCS-facilitation of cue-exposure therapy improves abstinence among smokers on the nicotine patch seeking treatment. Development of an effective treatment strategy to enhance the effectiveness of NRTs would have a direct and significant positive impact on public health.

研究设计

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

入排标准

年龄范围
21 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Seeking treatment for nicotine dependence
  • Medically healthy on the basis of physical examination and medical history, vital signs, EKG, and laboratory tests, with a negative pregnancy test for females.
  • A DSM-IV diagnosis of nicotine dependence with physiological dependence. Has smoked at least 15 cigarettes daily for at least two years.
  • Able to perform study procedures.
  • Males or females between the ages of 21-55 yrs.
  • Female Participants agree to use an effective method of birth control

排除标准

  • A DSM-IV diagnosis of lifetime history of abuse or dependence on alcohol or drugs other than nicotine
  • Current Axis I diagnosis or current treatment with psychotropic medications (within last three months).
  • Lifetime history of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders.
  • Participants on parole or probation
  • History of significant recent violent behavior, e.g., one or more incidents of violent behavior in the past year resulting in physical damage.
  • Unstable medical condition, Blood pressure > 140/90, Pregnancy.
  • History of allergic reaction to nicotine patch.
  • History of hypersensitivity to cycloserine.
  • Any history of seizures
  • History of renal disease.

研究组 & 干预措施

Gelatin Capsule

Placebo Comparator

The investigators will randomize participants to either DCS 250 mg or placebo, administered daily for four days.

干预措施: Placebo (Drug)

D-cycloserine

Active Comparator

The investigators will randomize participants to either DCS 250 mg or placebo, administered daily for four days.

干预措施: D-cycloserine (Drug)

D-cycloserine

Active Comparator

The investigators will randomize participants to either DCS 250 mg or placebo, administered daily for four days.

干预措施: Nicotine Replacement Therapy (patch) (Drug)

D-cycloserine

Active Comparator

The investigators will randomize participants to either DCS 250 mg or placebo, administered daily for four days.

干预措施: Smoking Cue Exposure (Behavioral)

D-cycloserine

Active Comparator

The investigators will randomize participants to either DCS 250 mg or placebo, administered daily for four days.

干预措施: Progressive Muscle Relaxation (Behavioral)

Gelatin Capsule

Placebo Comparator

The investigators will randomize participants to either DCS 250 mg or placebo, administered daily for four days.

干预措施: Nicotine Replacement Therapy (patch) (Drug)

Gelatin Capsule

Placebo Comparator

The investigators will randomize participants to either DCS 250 mg or placebo, administered daily for four days.

干预措施: Smoking Cue Exposure (Behavioral)

Gelatin Capsule

Placebo Comparator

The investigators will randomize participants to either DCS 250 mg or placebo, administered daily for four days.

干预措施: Progressive Muscle Relaxation (Behavioral)

结局指标

主要结局

Number of Cigarettes Smoked

时间窗: 3 months

Smoking Diary kept of daily cigarette smoking.

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

S. Rob Vorel

Principal Investigator

New York State Psychiatric Institute

研究点 (1)

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