NCT00913484已完成2 期
Disulfiram for Cocaine Abuse in Buprenorphine Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 2
- 主要终点
- Cocaine abstinence
研究概览
简要总结
The investigators are proposing a placebo-controlled clinical trial to evaluate the efficacy and potential mechanisms of action of disulfiram (versus placebo) for treating cocaine abuse in subjects with concurrent opiate dependence and cocaine abuse or dependence maintained on buprenorphine/naloxone combination.
详细描述
The Specific Aims and hypotheses for the proposed study are as follows:
- To compare the efficacy of disulfiram versus placebo for the treatment of buprenorphine maintained patients with concurrent opioid and cocaine dependence. Study hypothesis 1 is that disulfiram is superior to placebo.
- To evaluate whether dopamine-B-hydroxylase (DBH) genotypes associated with high, intermediate or low enzyme activity predict responses to disulfiram treatment of cocaine use in buprenorphine treated subjects. Study hypothesis 2 is that disulfiram efficacy is higher in subjects with low DBH compared to subjects with high DBH.
- To explore whether baseline measures of alcohol use predict response to disulfiram. Study Hypothesis 3 is that the effects of disulfiram on cocaine use are independent of the severity of baseline alcohol use.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking adults ages 18 -
- •Meeting FDA criteria for agonist maintenance treatment and DSM-IV criteria for opioid dependence and cocaine dependence or abuse as assessed by SCID interview and documented by opioid positive and cocaine positive urine toxicology testing.
- •Women of childbearing age will be included provided they agree to adequate contraception and to monthly pregnancy testing during the course of the study.
排除标准
- •Current physiologic dependence on benzodiazepines or alcohol, unless first detoxified. Subjects who use/abuse alcohol will be included but will be cautioned about alcohol use during the study because of the possibility of an alcohol-disulfiram reaction.
- •Use of the antibiotic agents metronidazole or clotrimazole, which have disulfiram-like effects in combination with alcohol.
- •Presence of significant cardiovascular, renal, hepatic or neurologic illness. Subjects with markedly abnormal liver function tests (i.e., AST of ALT > 3X normal) will also be excluded.
- •Presence of any of the following cardiovascular risk factors:
- •age > 45 years
- •history of cocaine-related chest pain
- •systolic blood pressure > 140 or diastolic blood pressure > 90
- •evidence of ischemia or past myocardial infarction on EKG
- •significant family history of risk (first degree relative with myocardial infarction prior to age 60)
- •elevated cholesterol (> 300 mg/dl), elevated LDL (> 170 mg/dl) or low HDL (< 20 mg/dl)
- •Maintenance on methadone at doses greater than 30mg daily. Admittance to the study will only be offered to individuals who have been maintained on 30 mg of methadone or less daily for seven days prior to entering the study.
- •Current suicide or homicide risk or current psychotic disorder.
- •Inability to read or understand the symptom checklists.
研究组 & 干预措施
Disulfiram
Experimental
Disulfiram 250 mg per day
干预措施: Disulfiram (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Cocaine abstinence
时间窗: 12 weeks
次要结局
- Opioid abstinence(12 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Cocaine Use Reduction With BuprenorphineCocaine DependenceNCT01402492University of California, Los Angeles302
已完成
2 期
Phase II Trial of Disulfiram With Copper in Metastatic Breast CancerBreast Neoplasm FemaleMetastatic Breast CancerNCT03323346The Institute of Molecular and Translational Medicine, Czech Republic9
已完成
3 期
Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or KneeOsteoarthritisNCT00313846Purdue Pharma LP529
已完成
2 期
Disulfiram for Cocaine-Alcohol Abuse - 3Alcohol-Related DisordersCocaine-Related DisordersNCT00000278Yale University
已完成
2 期
Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During PregnancySmoking CessationNCT01286402The University of Texas Health Science Center, Houston11