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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
8
In each arm, subjects will receive doses of methamphetamine.
In each arm, subjects will receive methylphenidate capsules.
In each arm, subjects will receive placebo capsules.
University of Kentucky
Lexington, Kentucky, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Reinforcing Effects of Methamphetamine Following Methylphenidate (0 mg; Placebo) Maintenance.
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).
Time frame: Following at least 4 days of maintenance on placebo during inpatient admission, up to 1 week
Reinforcing Effects of Methamphetamine Following Methylphenidate (20 mg) Maintenance.
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).
Time frame: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week
Reinforcing Effects of Methamphetamine Following Methylphenidate (40 mg) Maintenance.
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).
Time frame: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week
Reinforcing Effects of Methamphetamine Following Methylphenidate (60 mg) Maintenance.
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).
Time frame: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week
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Subjects will receive duloxetine capsules in the duloxetine arm.
Heart Rate After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Time frame: Daily over approximately 1 week of inpatient stay.
Heart Rate After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Time frame: Daily over approximately 1 week of inpatient stay.
Heart Rate After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Time frame: Daily over approximately 1 week of inpatient stay.
Heart Rate After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Heart Rate (beats per minute) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Time frame: Daily over approximately 1 week of inpatient stay.
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Time frame: Daily over approximately 1 week of inpatient stay.
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Time frame: Daily over approximately 1 week of inpatient stay.
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Time frame: Daily over approximately 1 week of inpatient stay.
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Systolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Time frame: Daily over approximately 1 week of inpatient stay.
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Time frame: Daily over approximately 1 week of inpatient stay.
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Time frame: Daily over approximately 1 week of inpatient stay.
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Time frame: Daily over approximately 1 week of inpatient stay.
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Diastolic blood pressure (millimeter of mercury) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Time frame: Daily over approximately 1 week of inpatient stay.
Temperature After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Time frame: Daily over approximately 1 week of inpatient stay.
Temperature After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Time frame: Daily over approximately 1 week of inpatient stay.
Temperature After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Time frame: Daily over approximately 1 week of inpatient stay.
Temperature After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
Oral temperature (degrees fahrenheit) is recorded following administration of methamphetamine. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of methamphetamine (0, 10, and 20 mg)
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Time frame: Daily over approximately 1 week of inpatient stay.
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
Subjective effects (i.e., mood) of methamphetamine are recorded following administration. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of methamphetamine.
Time frame: Daily over approximately 1 week of inpatient stay.