A Novel Drug Combination as a Pharmacotherapeutic for Methamphetamine-Use Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Craig Rush
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Reinforcing Effects of Methamphetamine Following Methylphenidate (0 mg; Placebo) Maintenance.
研究概览
简要总结
This study will evaluate the behavioral effects of methamphetamine during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, 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
- •recent use of inhaled (i.e., snorted), smoked or injected methamphetamine
排除标准
- •Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant.
- •Current or past histories of substance use that are deemed by the study physicians to interfere with study completion.
- •History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation.
- •Females not currently using effective birth control.
- •Contraindications to methamphetamine, methylphenidate, or duloxetine.
研究组 & 干预措施
Placebo Comparator: Placebo
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
干预措施: Methamphetamine (Drug)
Placebo Comparator: Placebo
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
干预措施: Methylphenidate (Drug)
Placebo Comparator: Placebo
Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
干预措施: Placebo oral capsule (Drug)
Active Comparator: Duloxetine
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
干预措施: Methamphetamine (Drug)
Active Comparator: Duloxetine
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
干预措施: Methylphenidate (Drug)
Active Comparator: Duloxetine
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
干预措施: Placebo oral capsule (Drug)
Active Comparator: Duloxetine
Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
干预措施: Duloxetine (Drug)
结局指标
主要结局
Reinforcing Effects of Methamphetamine Following Methylphenidate (0 mg; Placebo) Maintenance.
时间窗: Following at least 4 days of maintenance on placebo during inpatient admission, up to 1 week
Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have ten opportunities (e.g., trials) to "work" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).
Reinforcing Effects of Methamphetamine Following Methylphenidate (60 mg) Maintenance.
时间窗: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week
Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to "work" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).
Reinforcing Effects of Methamphetamine Following Methylphenidate (20 mg) Maintenance.
时间窗: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week
Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to "work" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).
Reinforcing Effects of Methamphetamine Following Methylphenidate (40 mg) Maintenance.
时间窗: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week
Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to "work" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).
次要结局
- Heart Rate After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Heart Rate After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Heart Rate After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Heart Rate After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Temperature After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Temperature After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Temperature After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Temperature After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)
- Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.(Daily over approximately 1 week of inpatient stay.)