Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Confirmed Abstinence From Cocaine
研究概览
简要总结
The purpose of this study is to examine two medications, modafinil and citalopram, in the treatment of cocaine dependent individuals who are maintained on methadone.
详细描述
This is a 24-week, randomized, double-blind, placebo-controlled study examining two doses of modafinil (200 and 400 mg) and citalopram (20 and 40 mg) in the treatment of methadone maintained cocaine dependent individuals.
Participants will first be given methadone to determine its tolerated and effective doses. Most participants will be able to reach a stable dose of methadone within 7 to 10 days of methadone initiation. When 80% of the projected dose of methadone has been achieved, participants will begin the medication regimen of modafinil or citalopram. Modafinil will be given over a 7-day period. Dosing of modafinil will begin at 200 mg and, depending on the individual, may increase to 400 mg. Citalopram will be given in increasing doses, starting at 20 mg and increasing to 40mg.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meets cocaine abuse and dependence criteria (as determined by the SCID)
- •Meets opiate dependence criteria (as determined by the SCID)
- •In good general physical and psychiatric health (except for possible acute drug use related problems)
排除标准
- •Meets diagnostic criteria for other psychiatric disorders, including other forms of drug dependence (other than nicotine)
- •Current cardiovascular disease (as determined by an electrocardiogram)
- •Circumstances will not allow for completion of study (on probation or parole)
- •Ethical constraints of supervision do not allow confidentiality (on probation or parole)
研究组 & 干预措施
1
Modafinil 200mg / Methadone Maintenance (1.2mg/kg)
干预措施: Modafinil 200mg (Drug)
2
Modafinil 400mg/ Methadone Maintenance (1.2mg/kg)
干预措施: Modafinil 400mg (Drug)
3
Citalopram 20/ Methadone Maintenance 1.2mg/kg
干预措施: Citalopram 20mg (Drug)
4
Citalopram 40/ Methadone Maintenance 1.2 mg/kg
干预措施: Citalopram 40mg (Drug)
5
Placebo given to methadone-maintained subjects (1.2mg/kg) for the duration of the 12-week study
干预措施: Placebo (Drug)
结局指标
主要结局
Confirmed Abstinence From Cocaine
时间窗: 12 weeks of treatment
次要结局
- Retention(12 weeks of treatment)
- Medication Compliance(12 weeks of treatment)
研究者
Joy Schmitz
Professor - Psy, Behavioral Science
The University of Texas Health Science Center, Houston