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临床试验/NCT01067846
NCT01067846已完成不适用

The Clinical and Neural Response of Cocaine Addicts to Combination Treatment With a Cognitive Enhancer and Extinction-Based Psychotherapy

University of Arkansas1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
85
试验地点
1
主要终点
Drug Abstinence During Treatment and at Follow up Visits

研究概览

简要总结

For this project, the investigators are interested in exploring a new way to extend and maintain drug abstinence in people who are addicted to crack cocaine. This study will combine a medication called D-Cycloserine (DCS) and weekly cognitive behavioral therapy (CBT) to assess whether the combination will enhance people's ability to stay clean (drug free) for longer periods of time.

One of the greatest risks for drug relapse is drug craving. Oftentimes drug craving occurs when a person is confronted with stressors and reminders of past drug use behavior. DCS has been shown to enhance the learning of new information. By administering DCS prior to learning new techniques such as how to cope with drug craving and drug-use reminders, it is possible that patients can be more successful at living a drug free life for a longer period of time.

In addition to exploring this model behaviorally, the investigators will explore changes that may occur in the brain before and after the therapy/medication intervention. A technique called MRI (Magnetic Resonance Imaging) will be used to identify areas of the brain that are being activated during an attention task. Areas of neural activation will be assessed at study entry, end of therapy (4-week endpoint) and one month following completion of the treatment program.

详细描述

Primary Hypothesis:

Enhancing glutamatergic neurotransmission with DCS facilitates CBT-related relapse prevention by potentiating the behavioral and neural representation of the diminished drug motivation associated with cocaine cues.

Specific Aims:

  1. Determine if the short-term oral administration of DCS relative to placebo prior to CBT sessions facilitates cocaine abstinence and functional recovery, and reduces cocaine craving in treatment-seeking cocaine addicts.
  2. Determine if DCS administration relative to placebo facilitates CBT-related decreases in the behavioral and neural response to conditioned cocaine cues.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible subjects must be cocaine-dependent persons between 18 and 65 years

排除标准

  • Any current Axis-I psychiatric diagnosis other than cocaine or alcohol dependence or nicotine use
  • Any current or prior neurological disease, history of a major medical illness, or current use of psychotropic medications
  • Positive history of loss of consciousness of greater than 10 min
  • Significant current or prior cardiovascular disease (hypertension, arrhythmias) that is not medically stable
  • History of hospitalization within the previous six months for a medical illness
  • Deafness, blindness or other significant sensory impairment.
  • Contraindications for D-cycloserine and magnetic resonance imaging.

研究组 & 干预措施

DCS and Cognitive Behavioral Therapy

Experimental

Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.

干预措施: Seromycin (D-cycloserine, DCS) (Drug)

DCS and Cognitive Behavioral Therapy

Experimental

Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.

干预措施: Computerized Cognitive Behavioral Therapy (Behavioral)

Placebo and Cognitive Behavioral Therapy

Placebo Comparator

Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.

干预措施: Placebo (Drug)

Placebo and Cognitive Behavioral Therapy

Placebo Comparator

Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.

干预措施: Computerized Cognitive Behavioral Therapy (Behavioral)

结局指标

主要结局

Drug Abstinence During Treatment and at Follow up Visits

时间窗: Participants provided urine samples for drug testing during treatment which occurred 3 times per week for 4 weeks, at the end of treatment, and at a 1 and 2 month follow up visit

Percentage of the overall number of drug abstinences of participants measured by urine drug testing

Treatment Retention - Number of Visits During Treatment

时间窗: Treatment sessions included 3 visits per week for 4 weeks

Number of treatment visits attended prior to discontinuation of treatment

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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