Reid Malcolm S, Angrist Burt, Baker Sherryl, Woo Caroline, Schwartz Marion, Montgomery Ann, Majewska Dorota, Robinson James, Rotrosen John
Department of Psychiatry, New York University School of Medicine, VA New York Harbor Healthcare System, New York, NY 10010, USA.
Addiction. 2005 Mar;100 Suppl 1:32-42. doi: 10.1111/j.1360-0443.2005.00989.x.
To conduct a medication screening trial study on the efficacy of celecoxib versus placebo for the treatment of cocaine dependence.
A modified blinded, parallel group study in an outpatient setting using the Cocaine Rapid Efficacy and Safety Trials (CREST) study design.
The study was performed at the New York Medications Development Research Unit (MDRU).
All participants met Diagnostic and Statistical Manual version IV (DSM-IV) criteria for cocaine dependence and provided at least two urine samples positive for benzoylecgonine (BE) during the 2-week screening period. Twenty-three participants were enrolled in the treatment phase of the study.
After a 2-week screening period, subjects were assigned randomly to receive either celebrex (200 mg/day) or placebo for an 8-week treatment period. All subjects also received individual cognitive behavioral counseling during treatment.
Primary outcome measures included quantitative urine benzoylecgonine (BE) levels, self-report of drug use and global impression scores. Secondary outcomes included cocaine craving, study retention and related psychosocial measures. Safety measures included adverse event monitoring, vital signs and extrapyramidal side-effects tests.
Study retention was similar across both treatment groups and safety measures indicated that celecoxib was moderately tolerated. Cocaine use, as measured by self-report and urine BE levels at end of treatment, indicated weaker improvement in the celecoxib group. Reductions in the intensity of cocaine craving were also weaker in the celecoxib group. Cocaine abstinence rates, global impression scores and all other related psychometric measures did not differ significantly between treatment groups.
This study does not support the effectiveness of celecoxib for the treatment of cocaine dependence.
开展一项关于塞来昔布与安慰剂治疗可卡因依赖疗效的药物筛选试验研究。
采用可卡因快速疗效与安全性试验（CREST）研究设计，在门诊环境中进行的改良双盲平行组研究。
该研究在纽约药物研发研究单位（MDRU）进行。
所有参与者均符合《精神疾病诊断与统计手册》第四版（DSM-IV）可卡因依赖标准，且在2周筛查期内提供至少两份苯甲酰爱康宁（BE）阳性的尿液样本。23名参与者进入该研究的治疗阶段。
经过2周的筛查期后，受试者被随机分配接受塞来昔布（200毫克/天）或安慰剂治疗8周。所有受试者在治疗期间还接受个体认知行为咨询。
主要结局指标包括尿液中苯甲酰爱康宁（BE）的定量水平、药物使用的自我报告和整体印象评分。次要结局包括对可卡因的渴望、研究保留率及相关社会心理指标。安全指标包括不良事件监测、生命体征和锥体外系副作用测试。
两个治疗组的研究保留率相似，安全指标表明塞来昔布的耐受性中等。通过自我报告和治疗结束时尿液BE水平衡量的可卡因使用情况显示，塞来昔布组的改善较弱。塞来昔布组对可卡因渴望强度的降低也较弱。治疗组之间的可卡因戒断率、整体印象评分和所有其他相关心理测量指标无显著差异。
本研究不支持塞来昔布治疗可卡因依赖的有效性。
