Pharmacotherapy Dosing Regimen (Cocaine Dependence Population)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment
研究概览
简要总结
Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to examine the effects of d-amphetamine and modafinil, when given alone and in combination, in treating cocaine dependent individuals.
详细描述
Cocaine is a strong central nervous system stimulant that is widely abused throughout the United Sates. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Modafinil is a glutamate-enhancing agent. D-amphetamine is a central nervous system stimulant that is approved to treat individuals with narcolepsy and attention deficit disorder. Both modafinil and d-amphetamine may be effective treatments for cocaine dependence. The purpose of this study is to examine the effectiveness of modafinil and d-amphetamine, alone and in combination, in treating cocaine dependent individuals.
This study will last 16 weeks. Participants will be randomly assigned to one of four groups: 1) 60 mg dose of d-amphetamine; 2) 400 mg dose of modafinil; 3) 30 mg dose of d-amphetamine combined with 200 mg dose of modafinil; and 4) placebo. All participants will receive 200 mg of modafinil over 4 days.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meets Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-IV (SCID) criteria for cocaine abuse or dependence
- •In general good health. Individuals who are HIV-positive will not be excluded if in good general health, unless medication interactions exist.
排除标准
- •Meets diagnostic criteria for psychiatric disorders, including other forms of drug dependence, other than nicotine
- •Current cardiovascular disease, as determined by an electrocardiogram
- •On probation or parole if the circumstances do not allow study completion or if ethical constraints of supervision do not allow confidentiality
- •Previously received treatment with d-amphetamine, modafinil, or aripiprazole
- •Currently receiving prescribed medication
研究组 & 干预措施
D-Amphetamine 60mg + Therapy
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine sustained release (SR) (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
干预措施: D-Amphetamine 60mg (Drug)
D-Amphetamine 60mg + Therapy
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine sustained release (SR) (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
干预措施: Therapy (Behavioral)
Modafinil 400mg + Therapy
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
干预措施: Modafinil 400mg (Drug)
Modafinil 400mg + Therapy
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
干预措施: Therapy (Behavioral)
Modafinil 200mg + D-Amphetamine 30mg + Therapy
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
干预措施: D-Amphetamine 30mg (Drug)
Modafinil 200mg + D-Amphetamine 30mg + Therapy
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
干预措施: Modafinil 200mg (Drug)
Modafinil 200mg + D-Amphetamine 30mg + Therapy
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
干预措施: Therapy (Behavioral)
Placebo + Therapy
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
干预措施: Therapy (Behavioral)
Placebo + Therapy
During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
干预措施: Placebo (Drug)
结局指标
主要结局
Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment
时间窗: 16 weeks
Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment
时间窗: 16 weeks
Retention as Indicated by the Number of Participants Who Remained in the Study
时间窗: 16 weeks
次要结局
- Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples(16 weeks)
- Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report(16 weeks)
研究者
Joy Schmitz
Professor - PSY-Behavioral Sciences
The University of Texas Health Science Center, Houston