NCT01319214Unknown不适用
Reconsolidation as a Treatment Target for Cocaine Addiction
McGill University Health Centre/Research Institute of the McGill University Health Centre0 个研究点目标入组 60 人开始时间: 2011年3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
- 发起方
- 入组人数
- 60
- 主要终点
- Self-report drug craving
研究概览
简要总结
The primary objective is to investigate the potential ability of Inderal (propranolol hydrochloride) to diminish the reconsolidation of motivationally potent drug-related cues in cocaine dependent participants. If effective in this laboratory model, Inderal may have clinical efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 psychotropic medication-free men or women (15 subjects x 4 groups) who have met DSM-IV-TR diagnostic criteria for cocaine dependence for the past 6 months (age 18 - 50 years old);
- •Minimum of three days cocaine abstinent on study days;
- •Primary use of cocaine is intra-nasal or smoked crack
排除标准
- •Medical conditions that might be aggravated by participation in the study:
- •cardiovascular disorders that might be aggravated by participation in the study: hypotension (SBP: < 100 mmHg), bradycardia (heart rate < 60 /min), severe atrioventricular block (Type II or III), severe hypertension (SBP: > 160 mmHg; DBP: > 100 mmHg), myocardial infarction, history of chest pain and admission to ED for chest pain;
- •respiratory disorders: bronchial asthma and chronic obstructive pulmonary disease;
- •diabetic patients treated with insulin or oral hypoglycemic agents. Propranolol may mask the first signs of a developing hypoglycemia.
- •Seropositive pregnancy test
- •Comorbidity with current axis I psychiatric disorders other than anxiety, affective and substance use disorders
- •Severe liver disfunction
- •Current or recent (< 5 half lives) use of medications that may interact with Inderal (see above)
- •Positive urine tox screen for barbiturates. Positive breath alcohol screen. {Note: all urine tox screen results will be destroyed immediately after collection. The information will not be stored}
研究组 & 干预措施
Inderal, neutral cues
Experimental
干预措施: Inderal (Drug)
Inderal, drug cues
Experimental
干预措施: Inderal (Drug)
Placebo, neutral cues
Experimental
干预措施: Inderal (Drug)
Placebo, drug cues
Experimental
干预措施: Inderal (Drug)
结局指标
主要结局
Self-report drug craving
时间窗: One day and one month post-treatment
One day and one month after the intervention, the investigators will measure drug craving using visual analog scales (VAS) and the Cocaine Craving Questionnaire (CCQ).
次要结局
- Drug use(One month after the intervention)
研究者
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