A Phase 1 interventional study of Methamphetamine and Methylphenidate in Methamphetamine Use Disorder, sponsored by Craig Rush. Completed at 2 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-09.
Sponsored by Craig Rush · Phase 1, Interventional, and Basic science
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.
Exclusion Criteria:
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.
Drug: Methamphetamine · Drug: Methylphenidate · Drug: Placebo oral capsule
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.
Drug: Methamphetamine · Drug: Methylphenidate · Drug: Placebo oral capsule · Drug: Duloxetine
In each arm, subjects will receive doses of methamphetamine.
Also known as: Metamfetamine
In each arm, subjects will receive methylphenidate capsules.
Also known as: Metadate®
In each arm, subjects will receive placebo capsules.
Also known as: Lactose
Subjects will receive duloxetine capsules in the duloxetine arm.
Also known as: Cymbalta®
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
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.
Attentional Bias
Subjects will complete an attentional bias task. The number of inhibitory failures (i.e., commission errors) to "no-go" targets following methamphetamine-related stimuli will be used to evaluate attentional bias (range 0 - 1: greater values represent greater number of errors committed). Commission errors are when you response (i.e., press the corresponding key on a computer) when you were instructed not to respond.
Time frame: 12 sessions over approximately 4.5 weeks
Snaith-Hamilton-Pleasure Scale to Measure Anhedonia (Inability to Experience Pleasure)
A 14-item Snaith-Hamilton-Pleasure Scale covers four domains of pleasure response (interest/pastimes, social interaction, sensory experience and food/drink) with higher scores representing less anhedonia. Scores range from 0 to 56 units: lower scores representing greater anhedonia.
Time frame: 4 times over approximately 4.5 weeks
Delay Discounting for Methamphetamine
Subjects will complete a delay discounting task in 4 sessions following 4 days of medication maintenance. Subjects are presented a series of hypothetical choices between a smaller amount of methamphetamine offered "now" or a larger amount of methamphetamine offered a later times in the future (e.g., 4 hours, a day, 3 weeks). The discounting rate, 'k', is calculated and log10-transformed. Greater values of log-transformed 'k' correspond with greater rates of discounting (i.e., preference for smaller reinforcer provided now rather than larger, delayed reinforcers \[e.g., smaller amount of methamphetamine given now as opposed to a larger amount given later\]). The units for discounting rates are theoretical and not linked to a physical dimension (e.g., number of button presses) and the range is theoretically not bound (i.e., negative infinity to positive infinity).
Time frame: 4 sessions over approximately 4.5 weeks
Delay Discounting for Money
Subjects will complete a delay discounting task in 4 sessions following 4 days of medication maintenance. Subjects are presented a series of hypothetical choices between a smaller sum of money offered "now" or a larger sum of money offered a later times in the future (e.g., 4 hours, a day, 3 weeks). The discounting rate, 'k', is calculated and log10-transformed. Greater values of log-transformed 'k' correspond with greater rates of discounting (i.e., preference for smaller reinforcer provided now rather than larger, delayed reinforcers \[e.g., smaller sum of money given now as opposed to a larger sum given later\]). The units for discounting rates are theoretical and not linked to a physical dimension (e.g., number of button presses) and the range is theoretically not bound (i.e., negative infinity to positive infinity).
Time frame: 4 sessions over approximately 4.5 weeks
| Milestone | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Started | 4 | 4 |
| Completed | 3 | 4 |
| Not completed | 1 | 0 |
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).
| Trials Completed | Placebo Comparator: Placebo | Active Comparator: Duloxetine (60 mg) |
|---|---|---|
| Methamphetamine (0mg) | 0 ± 0 | 0 ± 0 |
| Methamphetamine (10mg) | 3.33 ± 5.77 | 7.25 ± 4.86 |
| Methamphetamine (20mg) | 10 ± 0 | 9.75 ± 0.50 |
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).
| Trials Completed | Placebo Comparator: Placebo | Active Comparator: Duloxetine (60 mg) |
|---|---|---|
| Methamphetamine (0mg) | 0 ± 0 | 2.50 ± 5.00 |
| Methamphetamine (10mg) | 6.67 ± 5.77 | 7.00 ± 4.69 |
| Methamphetamine (20mg) | 8.00 ± 3.46 | 9.75 ± 0.50 |
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).
| Trials Completed | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Methamphetamine (0mg) | 1.67 ± 2.89 | 0 ± 0 |
| Methamphetamine (10mg) | 10 ± 0 | 5.00 ± 5.77 |
| Methamphetamine (20mg) | 10 ± 0 | 10 ± 0 |
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).
| Trials Completed | Placebo Comparator: Placebo | Active Comparator: Duloxetine (60 mg) |
|---|---|---|
| Methamphetamine (0mg) | 2.33 ± 4.04 | 0 ± 0 |
| Methamphetamine (10mg) | 3.33 ± 5.77 | 7.50 ± 5.00 |
| Methamphetamine (20mg) | 10 ± 0 | 9.75 ± 0.50 |
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)
| Beats Per Minute | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Methamphetamine (0 mg) | 77.67 ± 16.17 | 78.00 ± 6.98 |
| Methamphetamine (10 mg) | 87.33 ± 15.14 | 77.25 ± 15.37 |
| Methamphetamine (20 mg) | 81.33 ± 12.01 | 83.75 ± 15.20 |
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)
| Beats Per Minute | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Methamphetamine (0 mg) | 83.67 ± 2.06 | 76.00 ± 8.41 |
| Methamphetamine (10 mg) | 84.33 ± 8.50 | 78.50 ± 15.63 |
| Methamphetamine (20 mg) | 85.67 ± 8.74 | 89.50 ± 16.90 |
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)
| Beats Per Minute | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Methamphetamine (0 mg) | 85.00 ± 13.08 | 91.25 ± 23.47 |
| Methamphetamine (10 mg) | 89.67 ± 10.21 | 87.75 ± 17.50 |
| Methamphetamine (20 mg) | 87.67 ± 12.86 | 87.00 ± 15.08 |
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)
| Beats Per Minute | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Methamphetamine (0 mg) | 87.33 ± 15.28 | 88.00 ± 19.11 |
| Methamphetamine (10 mg) | 83.67 ± 11.72 | 87.50 ± 10.50 |
| Methamphetamine (20 mg) | 99.67 ± 10.69 | 88.00 ± 19.36 |
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)
| Millimeter of Mercury | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Methamphetamine (0 mg) | 132.67 ± 2.89 | 128.75 ± 16.58 |
| Methamphetamine (10 mg) | 133.00 ± 13.45 | 131.00 ± 11.83 |
| Methamphetamine (20 mg) | 132.67 ± 5.03 | 144.25 ± 14.08 |
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)
| Millimeter of Mercury | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Methamphetamine (0 mg) | 129.67 ± 2.31 | 124.25 ± 25.02 |
| Methamphetamine (10 mg) | 131.67 ± 18.61 | 128.00 ± 17.22 |
| Methamphetamine (20 mg) | 130.33 ± 13.20 | 132.75 ± 15.95 |
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)
| Millimeter of Mercury | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Methamphetamine (0 mg) | 133.33 ± 2.08 | 129.75 ± 11.47 |
| Methamphetamine (10 mg) | 129.00 ± 12.77 | 132.25 ± 15.41 |
| Methamphetamine (20 mg) | 130.00 ± 10.44 | 139.25 ± 11.67 |
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)
| Millimeter of Mercury | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Methamphetamine (0 mg) | 139.00 ± 4.00 | 127.00 ± 15.06 |
| Methamphetamine (10 mg) | 138.67 ± 11.59 | 129.75 ± 14.97 |
| Methamphetamine (20 mg) | 139.67 ± 3.06 | 135.25 ± 15.39 |
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)
| Millimeter of Mercury | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Methamphetamine (0 mg) | 80.00 ± 3.00 | 78.50 ± 7.77 |
| Methamphetamine (10 mg) | 82.33 ± 0.58 | 83.75 ± 9.54 |
| Methamphetamine (20 mg) | 87.33 ± 5.51 | 86.25 ± 7.89 |
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)
| Millimeter of Mercury | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Methamphetamine (0 mg) | 81.67 ± 4.51 | 74.50 ± 10.02 |
| Methamphetamine (10 mg) | 85.33 ± 8.50 | 83.25 ± 11.03 |
| Methamphetamine (20 mg) | 83.00 ± 3.61 | 85.00 ± 7.96 |
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)
| Millimeter of Mercury | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Methamphetamine (0 mg) | 78.00 ± 2.65 | 81.00 ± 9.56 |
| Methamphetamine (10 mg) | 84.67 ± 5.51 | 82.25 ± 8.10 |
| Methamphetamine (20 mg) | 84.67 ± 6.51 | 85.00 ± 6.06 |
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)
| Millimeter of Mercury | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Methamphetamine (0 mg) | 82.67 ± 5.51 | 82.25 ± 5.74 |
| Methamphetamine (10 mg) | 81.67 ± 8.08 | 82.25 ± 7.93 |
| Methamphetamine (20 mg) | 88.33 ± 4.73 | 84.25 ± 10.37 |
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)
| Degrees Fahrenheit | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Methamphetamine (0 mg) | 98.10 ± 0.26 | 98.45 ± 0.10 |
| Methamphetamine (10 mg) | 98.23 ± 0.40 | 98.48 ± 0.21 |
| Methamphetamine (20 mg) | 98.40 ± 0.36 | 98.48 ± 0.19 |
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)
| Degrees Fahrenheit | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Methamphetamine (0 mg) | 98.37 ± 0.23 | 98.50 ± 0.08 |
| Methamphetamine (10 mg) | 98.10 ± 0.36 | 98.75 ± 0.26 |
| Methamphetamine (20 mg) | 98.27 ± 0.32 | 98.35 ± 0.10 |
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)
| Degrees Fahrenheit | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Methamphetamine (0 mg) | 98.17 ± 0.15 | 98.60 ± 0.22 |
| Methamphetamine (10 mg) | 98.13 ± 0.40 | 98.65 ± 0.17 |
| Methamphetamine (20 mg) | 98.43 ± 0.15 | 98.55 ± 0.26 |
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)
| Degrees Fahrenheit | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Methamphetamine (0 mg) | 98.37 ± 0.35 | 98.65 ± 0.17 |
| Methamphetamine (10 mg) | 98.43 ± 0.15 | 98.65 ± 0.06 |
| Methamphetamine (20 mg) | 98.47 ± 0.35 | 98.58 ± 0.10 |
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.
| Millimeters | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Sluggish/Fatigued/Lazy | 1.33 ± 1.53 | 0.00 ± 0.00 |
| Restless | 1.00 ± 1.73 | 0.00 ± 0.00 |
| Nervous/Anxious | 1.00 ± 1.73 | 0.00 ± 0.00 |
| Nauseated/Queasy/Sick to Stomach | 1.00 ± 1.73 | 0.00 ± 0.00 |
| Talkative/Friendly | 1.00 ± 1.73 | 0.00 ± 0.00 |
| Irregular/Racing Heartbeat | 1.33 ± 2.31 | 0.00 ± 0.00 |
| Euphoric | 0.67 ± 1.15 | 0.00 ± 0.00 |
| Shaky/Jittery | 1.33 ± 2.31 | 0.00 ± 0.00 |
| Active/Alert/Energetic | 1.33 ± 2.31 | 1.50 ± 3.00 |
| Will Pay For | 1.33 ± 2.31 | 0.25 ± 0.50 |
| Will Take Again | 1.67 ± 2.89 | 1.50 ± 3.00 |
| Performance Improved | 1.33 ± 2.31 | 0.00 ± 0.00 |
| Performance Impaired | 1.00 ± 1.73 | 0.00 ± 0.00 |
| Stimulated | 1.00 ± 1.73 | 2.25 ± 4.50 |
| Like Drug | 1.00 ± 1.73 | 0.00 ± 0.00 |
| Rush | 1.00 ± 1.73 | 0.25 ± 0.50 |
| High | 0.67 ± 1.15 | 0.00 ± 0.00 |
| Good Effects | 1.33 ± 2.31 | 0.25 ± 0.50 |
| Bad Effects | 1.00 ± 1.73 | 0.00 ± 0.00 |
| Any Effect | 1.00 ± 1.73 | 1.25 ± 2.50 |
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.
| Millimeters | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Sluggish/Fatigued/Lazy | 22.33 ± 35.28 | 0.00 ± 0.00 |
| Restless | 1.00 ± 1.73 | 1.00 ± 2.00 |
| Nervous/Anxious | 0.67 ± 1.15 | 0.00 ± 0.00 |
| Nauseated/Queasy/Sick to Stomach | 3.00 ± 5.20 | 0.00 ± 0.00 |
| Talkative/Friendly | 4.33 ± 6.66 | 12.50 ± 23.04 |
| Irregular/Racing Heartbeat | 0.33 ± 0.58 | 2.25 ± 4.50 |
| Euphoric | 15.67 ± 14.29 | 18.25 ± 36.50 |
| Shaky/Jittery | 1.00 ± 1.73 | 0.00 ± 0.00 |
| Active/Alert/Energetic | 15.33 ± 24.83 | 25.50 ± 34.84 |
| Will Pay For | 23.00 ± 38.97 | 22.25 ± 35.98 |
| Will Take Again | 46.33 ± 45.06 | 23.50 ± 32.25 |
| Performance Improved | 7.00 ± 9.54 | 11.50 ± 21.05 |
| Performance Impaired | 11.33 ± 19.63 | 0.00 ± 0.00 |
| Stimulated | 21.33 ± 36.09 | 14.25 ± 18.15 |
| Like Drug | 33.67 ± 57.45 | 15.00 ± 15.10 |
| Rush | 10.67 ± 18.48 | 8.25 ± 11.32 |
| High | 9.33 ± 16.17 | 12.00 ± 14.28 |
| Good Effects | 12.67 ± 20.21 | 13.75 ± 15.95 |
| Bad Effects | 2.67 ± 4.62 | 0.00 ± 0.00 |
| Any Effect | 12.67 ± 20.21 | 16.00 ± 19.13 |
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.
| Millimeters | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Sluggish/Fatigued/Lazy | 10.33 ± 17.90 | 0.00 ± 0.00 |
| Restless | 0.67 ± 1.15 | 0.50 ± 1.00 |
| Nervous/Anxious | 0.67 ± 1.15 | 0.00 ± 0.00 |
| Nauseated/Queasy/Sick to Stomach | 0.33 ± 0.58 | 0.00 ± 0.00 |
| Talkative/Friendly | 20.00 ± 32.05 | 13.75 ± 26.84 |
| Irregular/Racing Heartbeat | 1.00 ± 1.73 | 4.25 ± 7.23 |
| Euphoric | 21.67 ± 37.53 | 16.00 ± 25.77 |
| Shaky/Jittery | 0.67 ± 1.15 | 0.00 ± 0.00 |
| Active/Alert/Energetic | 35.67 ± 55.72 | 27.99 ± 30.67 |
| Will Pay For | 36.67 ± 55.08 | 20.50 ± 33.81 |
| Will Take Again | 50.00 ± 47.70 | 25.25 ± 25.62 |
| Performance Improved | 26.33 ± 37.85 | 12.00 ± 23.34 |
| Performance Impaired | 32.67 ± 56.58 | 0.25 ± 0.50 |
| Stimulated | 38.33 ± 53.41 | 23.50 ± 27.09 |
| Like Drug | 37.67 ± 54.00 | 26.25 ± 27.56 |
| Rush | 31.33 ± 54.27 | 16.00 ± 20.54 |
| High | 36.67 ± 55.08 | 20.50 ± 22.55 |
| Good Effects | 30.33 ± 44.77 | 23.00 ± 23.17 |
| Bad Effects | 23.67 ± 40.99 | 0.25 ± 0.50 |
| Any Effect | 38.33 ± 43.89 | 24.50 ± 24.08 |
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.
| Millimeters | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Sluggish/Fatigued/Lazy | 3.00 ± 2.65 | 0.00 ± 0.00 |
| Restless | 1.33 ± 2.31 | 1.00 ± 2.00 |
| Nervous/Anxious | 1.67 ± 2.89 | 0.00 ± 0.00 |
| Nauseated/Queasy/Sick to Stomach | 1.67 ± 2.08 | 0.00 ± 0.00 |
| Talkative/Friendly | 4.00 ± 6.93 | 0.75 ± 1.50 |
| Irregular/Racing Heartbeat | 1.67 ± 2.89 | 0.25 ± 0.50 |
| Euphoric | 4.00 ± 6.93 | 0.00 ± 0.00 |
| Shaky/Jittery | 3.00 ± 5.20 | 0.00 ± 0.00 |
| Active/Alert/Energetic | 3.33 ± 5.77 | 0.75 ± 1.50 |
| Will Pay For | 8.00 ± 13.86 | 1.00 ± 2.00 |
| Will Take Again | 11.67 ± 20.21 | 1.50 ± 3.00 |
| Performance Improved | 2.67 ± 4.62 | 0.75 ± 1.50 |
| Performance Impaired | 2.33 ± 4.04 | 0.25 ± 0.50 |
| Stimulated | 4.67 ± 8.08 | 0.25 ± 0.50 |
| Like Drug | 7.67 ± 13.28 | 1.50 ± 3.00 |
| Rush | 4.67 ± 8.08 | 0.00 ± 0.00 |
| High | 4.33 ± 7.51 | 1.50 ± 3.00 |
| Good Effects | 4.00 ± 6.93 | 1.50 ± 3.00 |
| Bad Effects | 2.67 ± 4.62 | 0.00 ± 0.00 |
| Any Effect | 3.67 ± 6.35 | 1.50 ± 3.00 |
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.
| Millimeters | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Sluggish/Fatigued/Lazy | 10.67 ± 14.36 | 0.50 ± 1.00 |
| Restless | 2.00 ± 3.46 | 0.50 ± 1.00 |
| Nervous/Anxious | 2.00 ± 3.46 | 0.00 ± 0.00 |
| Nauseated/Queasy/Sick to Stomach | 0.33 ± 0.58 | 0.00 ± 0.00 |
| Talkative/Friendly | 14.67 ± 23.69 | 13.75 ± 26.18 |
| Irregular/Racing Heartbeat | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Euphoric | 22.00 ± 38.11 | 13.00 ± 26.00 |
| Shaky/Jittery | 0.67 ± 1.15 | 0.00 ± 0.00 |
| Active/Alert/Energetic | 17.33 ± 27.43 | 16.25 ± 23.30 |
| Will Pay For | 33.33 ± 57.74 | 18.50 ± 35.68 |
| Will Take Again | 40.00 ± 52.74 | 21.75 ± 34.25 |
| Performance Improved | 15.00 ± 23.39 | 13.00 ± 24.68 |
| Performance Impaired | 5.67 ± 9.81 | 0.00 ± 0.00 |
| Stimulated | 20.33 ± 32.65 | 11.75 ± 22.19 |
| Like Drug | 35.33 ± 56.01 | 14.00 ± 24.06 |
| Rush | 19.00 ± 32.91 | 3.00 ± 6.00 |
| High | 21.67 ± 37.53 | 14.25 ± 21.87 |
| Good Effects | 21.00 ± 30.35 | 9.75 ± 15.59 |
| Bad Effects | 6.33 ± 10.12 | 0.25 ± 0.50 |
| Any Effect | 16.00 ± 19.92 | 14.75 ± 18.39 |
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.
| Millimeters | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Sluggish/Fatigued/Lazy | 4.33 ± 7.51 | 0.00 ± 0.00 |
| Restless | 9.33 ± 16.17 | 1.00 ± 2.00 |
| Nervous/Anxious | 3.33 ± 5.77 | 0.00 ± 0.00 |
| Nauseated/Queasy/Sick to Stomach | 1.67 ± 2.89 | 0.50 ± 1.00 |
| Talkative/Friendly | 22.67 ± 37.54 | 14.50 ± 27.01 |
| Irregular/Racing Heartbeat | 3.00 ± 5.20 | 3.50 ± 5.20 |
| Euphoric | 33.33 ± 57.74 | 14.25 ± 22.34 |
| Shaky/Jittery | 1.33 ± 2.31 | 0.00 ± 0.00 |
| Active/Alert/Energetic | 30.00 ± 38.97 | 24.50 ± 25.75 |
| Will Pay For | 45.67 ± 50.56 | 17.25 ± 25.89 |
| Will Take Again | 48.00 ± 50.12 | 24.75 ± 28.37 |
| Performance Improved | 16.67 ± 23.39 | 14.50 ± 25.77 |
| Performance Impaired | 11.33 ± 19.63 | 0.25 ± 0.50 |
| Stimulated | 36.67 ± 55.08 | 19.75 ± 22.97 |
| Like Drug | 47.33 ± 50.21 | 18.75 ± 23.85 |
| Rush | 33.33 ± 57.74 | 12.75 ± 15.65 |
| High | 33.33 ± 57.74 | 16.50 ± 18.88 |
| Good Effects | 35.67 ± 55.73 | 14.25 ± 12.45 |
| Bad Effects | 6.33 ± 10.12 | 0.00 ± 0.00 |
| Any Effect | 36.33 ± 55.16 | 13.75 ± 12.84 |
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.
| Millimeters | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Sluggish/Fatigued/Lazy | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Restless | 0.00 ± 0.00 | 0.50 ± 1.00 |
| Nervous/Anxious | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Nauseated/Queasy/Sick to Stomach | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Talkative/Friendly | 8.00 ± 13.86 | 0.50 ± 1.00 |
| Irregular/Racing Heartbeat | 0.67 ± 1.15 | 0.00 ± 0.00 |
| Euphoric | 7.00 ± 12.12 | 0.00 ± 0.00 |
| Shaky/Jittery | 0.67 ± 1.15 | 0.00 ± 0.00 |
| Active/Alert/Energetic | 10.33 ± 17.90 | 0.50 ± 0.58 |
| Will Pay For | 17.33 ± 30.02 | 0.75 ± 1.50 |
| Will Take Again | 23.00 ± 39.84 | 1.00 ± 2.00 |
| Performance Improved | 6.67 ± 11.55 | 0.00 ± 0.00 |
| Performance Impaired | 7.67 ± 13.28 | 0.00 ± 0.00 |
| Stimulated | 17.33 ± 30.02 | 0.50 ± 1.00 |
| Like Drug | 16.33 ± 28.29 | 1.25 ± 2.50 |
| Rush | 8.00 ± 13.86 | 0.00 ± 0.00 |
| High | 10.67 ± 18.48 | 1.25 ± 2.50 |
| Good Effects | 8.33 ± 14.43 | 1.25 ± 2.50 |
| Bad Effects | 6.33 ± 10.97 | 0.00 ± 0.00 |
| Any Effect | 7.00 ± 12.12 | 4.25 ± 5.68 |
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.
| Millimeters | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Sluggish/Fatigued/Lazy | 8.67 ± 15.01 | 5.50 ± 11.00 |
| Restless | 5.33 ± 9.24 | 1.00 ± 2.00 |
| Nervous/Anxious | 3.00 ± 5.20 | 0.00 ± 0.00 |
| Nauseated/Queasy/Sick to Stomach | 2.00 ± 3.46 | 0.25 ± 0.50 |
| Talkative/Friendly | 18.67 ± 32.33 | 13.75 ± 24.86 |
| Irregular/Racing Heartbeat | 2.00 ± 2.65 | 1.25 ± 2.50 |
| Euphoric | 30.00 ± 51.96 | 9.75 ± 19.50 |
| Shaky/Jittery | 6.33 ± 10.12 | 0.00 ± 0.00 |
| Active/Alert/Energetic | 22.33 ± 37.82 | 20.25 ± 26.56 |
| Will Pay For | 33.00 ± 54.58 | 17.00 ± 28.77 |
| Will Take Again | 39.33 ± 51.60 | 17.25 ± 28.04 |
| Performance Improved | 20.00 ± 33.78 | 11.25 ± 20.55 |
| Performance Impaired | 6.00 ± 10.39 | 2.25 ± 4.50 |
| Stimulated | 31.33 ± 51.69 | 9.50 ± 16.38 |
| Like Drug | 33.67 ± 54.00 | 15.00 ± 24.18 |
| Rush | 30.00 ± 51.96 | 4.50 ± 8.35 |
| High | 30.33 ± 51.68 | 10.25 ± 15.48 |
| Good Effects | 31.33 ± 51.68 | 9.25 ± 13.52 |
| Bad Effects | 3.67 ± 6.35 | 2.50 ± 4.36 |
| Any Effect | 30.33 ± 49.94 | 11.50 ± 12.12 |
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.
| Millimeters | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Sluggish/Fatigued/Lazy | 1.33 ± 2.31 | 0.00 ± 0.00 |
| Restless | 0.33 ± 0.58 | 1.25 ± 2.50 |
| Nervous/Anxious | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Nauseated/Queasy/Sick to Stomach | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Talkative/Friendly | 25.33 ± 39.55 | 15.50 ± 27.01 |
| Irregular/Racing Heartbeat | 2.33 ± 4.04 | 0.75 ± 1.50 |
| Euphoric | 33.00 ± 54.58 | 14.75 ± 29.50 |
| Shaky/Jittery | 7.00 ± 12.12 | 1.25 ± 2.50 |
| Active/Alert/Energetic | 28.00 ± 41.68 | 24.75 ± 27.22 |
| Will Pay For | 38.00 ± 54.15 | 21.25 ± 27.71 |
| Will Take Again | 41.67 ± 51.81 | 23.75 ± 26.74 |
| Performance Improved | 12.33 ± 20.50 | 15.00 ± 26.77 |
| Performance Impaired | 5.33 ± 9.24 | 0.00 ± 0.00 |
| Stimulated | 31.67 ± 48.85 | 23.25 ± 26.89 |
| Like Drug | 34.33 ± 49.33 | 24.75 ± 26.29 |
| Rush | 29.00 ± 49.37 | 6.75 ± 11.59 |
| High | 28.00 ± 47.63 | 20.50 ± 22.22 |
| Good Effects | 35.00 ± 48.545 | 22.75 ± 22.01 |
| Bad Effects | 12.00 ± 10.82 | 0.00 ± 0.00 |
| Any Effect | 33.67 ± 49.66 | 19.50 ± 20.24 |
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.
| Millimeters | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Sluggish/Fatigued/Lazy | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Restless | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Nervous/Anxious | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Nauseated/Queasy/Sick to Stomach | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Talkative/Friendly | 12.33 ± 21.36 | 0.00 ± 0.00 |
| Irregular/Racing Heartbeat | 0.00 ± 0.00 | 0.50 ± 1.00 |
| Euphoric | 15.33 ± 26.56 | 0.00 ± 0.00 |
| Shaky/Jittery | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Active/Alert/Energetic | 14.00 ± 24.25 | 0.25 ± 0.50 |
| Will Pay For | 32.33 ± 50.06 | 0.00 ± 0.00 |
| Will Take Again | 31.00 ± 48.59 | 3.00 ± 4.24 |
| Performance Improved | 9.00 ± 15.59 | 0.00 ± 0.00 |
| Performance Impaired | 14.33 ± 24.83 | 0.00 ± 0.00 |
| Stimulated | 24.00 ± 41.57 | 0.00 ± 0.00 |
| Like Drug | 29.67 ± 47.96 | 0.50 ± 1.00 |
| Rush | 13.33 ± 23.09 | 0.00 ± 0.00 |
| High | 12.00 ± 20.78 | 2.00 ± 2.45 |
| Good Effects | 13.67 ± 23.67 | 0.75 ± 1.50 |
| Bad Effects | 3.00 ± 5.20 | 0.00 ± 0.00 |
| Any Effect | 15.33 ± 26.56 | 3.50 ± 5.74 |
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.
| Millimeters | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Sluggish/Fatigued/Lazy | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Restless | 5.00 ± 6.24 | 1.00 ± 2.00 |
| Nervous/Anxious | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Nauseated/Queasy/Sick to Stomach | 4.67 ± 8.08 | 0.00 ± 0.00 |
| Talkative/Friendly | 29.00 ± 50.23 | 11.00 ± 18.74 |
| Irregular/Racing Heartbeat | 0.00 ± 0.00 | 3.75 ± 3.77 |
| Euphoric | 28.33 ± 49.07 | 11.75 ± 16.50 |
| Shaky/Jittery | 3.67 ± 6.35 | 2.00 ± 4.00 |
| Active/Alert/Energetic | 25.00 ± 43.30 | 23.00 ± 23.17 |
| Will Pay For | 36.00 ± 54.74 | 18.00 ± 23.19 |
| Will Take Again | 33.33 ± 57.74 | 23.75 ± 23.89 |
| Performance Improved | 14.67 ± 25.40 | 9.50 ± 16.44 |
| Performance Impaired | 5.33 ± 9.24 | 0.00 ± 0.00 |
| Stimulated | 33.00 ± 52.83 | 17.25 ± 18.19 |
| Like Drug | 32.67 ± 55.72 | 23.75 ± 23.30 |
| Rush | 27.33 ± 47.34 | 10.75 ± 21.50 |
| High | 27.00 ± 46.77 | 15.75 ± 16.58 |
| Good Effects | 25.33 ± 43.88 | 20.25 ± 18.37 |
| Bad Effects | 4.67 ± 8.08 | 0.00 ± 0.00 |
| Any Effect | 24.67 ± 41.86 | 20.75 ± 18.39 |
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.
| Millimeters | Placebo Comparator: Placebo | Active Comparator: Duloxetine |
|---|---|---|
| Sluggish/Fatigued/Lazy | 6.67 ± 11.55 | 0.00 ± 0.00 |
| Restless | 0.00 ± 0.00 | 1.25 ± 1.89 |
| Nervous/Anxious | 0.33 ± 0.58 | 0.00 ± 0.00 |
| Nauseated/Queasy/Sick to Stomach | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Talkative/Friendly | 29.33 ± 50.23 | 18.25 ± 31.94 |
| Irregular/Racing Heartbeat | 30.67 ± 53.12 | 1.00 ± 2.00 |
| Euphoric | 32.33 ± 56.00 | 18.00 ± 35.34 |
| Shaky/Jittery | 2.00 ± 3.46 | 0.25 ± 0.50 |
| Active/Alert/Energetic | 37.33 ± 53.46 | 21.50 ± 29.92 |
| Will Pay For | 34.00 ± 57.17 | 18.75 ± 32.31 |
| Will Take Again | 37.67 ± 54.04 | 21.50 ± 30.49 |
| Performance Improved | 22.00 ± 33.05 | 18.75 ± 33.00 |
| Performance Impaired | 10.33 ± 17.90 | 13.50 ± 27.00 |
| Stimulated | 36.00 ± 53.73 | 20.25 ± 32.57 |
| Like Drug | 36.33 ± 54.31 | 21.50 ± 31.72 |
| Rush | 35.67 ± 53.35 | 2.50 ± 5.00 |
| High | 37.00 ± 54.03 | 20.25 ± 27.89 |
| Good Effects | 39.00 ± 53.23 | 20.25 ± 27.93 |
| Bad Effects | 9.67 ± 16.74 | 0.00 ± 0.00 |
| Any Effect | 38.00 ± 53.11 | 19.25 ± 24.78 |
Subjects will complete an attentional bias task. The number of inhibitory failures (i.e., commission errors) to "no-go" targets following methamphetamine-related stimuli will be used to evaluate attentional bias (range 0 - 1: greater values represent greater number of errors committed). Commission errors are when you response (i.e., press the corresponding key on a computer) when you were instructed not to respond.
| Proportion of Responses | Placebo Comparator: Placebo | Active Comparator: Duloxetine (60 mg) |
|---|---|---|
| Methylphenidate (0mg) | 0.07 ± 0.08 | 0.08 ± 0.07 |
| Methylphenidate (20mg) | 0.04 ± 0.04 | 0.13 ± 0.09 |
| Methylphenidate (40mg) | 0.08 ± 0.04 | 0.11 ± 0.05 |
| Methylphenidate (60mg) | 0.12 ± 0.11 | 0.12 ± 0.06 |
A 14-item Snaith-Hamilton-Pleasure Scale covers four domains of pleasure response (interest/pastimes, social interaction, sensory experience and food/drink) with higher scores representing less anhedonia. Scores range from 0 to 56 units: lower scores representing greater anhedonia.
| Units on a Scale | Placebo Comparator: Placebo | Active Comparator: Duloxetine (60 mg) |
|---|---|---|
| Methylphenidate (0 mg) | 44.33 ± 8.33 | 51.25 ± 6.60 |
| Methylphenidate (20 mg) | 44.00 ± 3.46 | 52.75 ± 4.72 |
| Methylphenidate (40 mg) | 44.33 ± 5.51 | 54.00 ± 2.45 |
| Methylphenidate (60 mg) | 44.67 ± 5.88 | 53.00 ± 6.00 |
Subjects will complete a delay discounting task in 4 sessions following 4 days of medication maintenance. Subjects are presented a series of hypothetical choices between a smaller amount of methamphetamine offered "now" or a larger amount of methamphetamine offered a later times in the future (e.g., 4 hours, a day, 3 weeks). The discounting rate, 'k', is calculated and log10-transformed. Greater values of log-transformed 'k' correspond with greater rates of discounting (i.e., preference for smaller reinforcer provided now rather than larger, delayed reinforcers \[e.g., smaller amount of methamphetamine given now as opposed to a larger amount given later\]). The units for discounting rates are theoretical and not linked to a physical dimension (e.g., number of button presses) and the range is theoretically not bound (i.e., negative infinity to positive infinity).
| log(k) | Placebo Comparator: Placebo | Active Comparator: Duloxetine (60 mg) |
|---|---|---|
| Methylphenidate (0mg) | -1.40 ± 1.63 | -1.31 ± 0.72 |
| Methylphenidate (20mg) | -1.04 ± 1.10 | -1.27 ± 0.49 |
| Methylphenidate (40mg) | -1.45 ± 1.63 | -1.15 ± 0.33 |
| Methylphenidate (60mg) | -1.17 ± 1.91 | -1.04 ± 0.43 |
Subjects will complete a delay discounting task in 4 sessions following 4 days of medication maintenance. Subjects are presented a series of hypothetical choices between a smaller sum of money offered "now" or a larger sum of money offered a later times in the future (e.g., 4 hours, a day, 3 weeks). The discounting rate, 'k', is calculated and log10-transformed. Greater values of log-transformed 'k' correspond with greater rates of discounting (i.e., preference for smaller reinforcer provided now rather than larger, delayed reinforcers \[e.g., smaller sum of money given now as opposed to a larger sum given later\]). The units for discounting rates are theoretical and not linked to a physical dimension (e.g., number of button presses) and the range is theoretically not bound (i.e., negative infinity to positive infinity).
| log(k) | Placebo Comparator: Placebo | Active Comparator: Duloxetine (60 mg) |
|---|---|---|
| Methylphenidate (0mg) | -1.40 ± 1.63 | -1.29 ± 0.76 |
| Methylphenidate (20mg) | -1.40 ± 1.63 | -1.37 ± 0.58 |
| Methylphenidate (40mg) | -1.45 ± 1.63 | -1.15 ± 0.33 |
| Methylphenidate (60mg) | -1.48 ± 1.43 | -1.04 ± 0.43 |
Collected over Assessed during 4.5 weeks of inpatient study.. Non-serious events are listed at a 0.29% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Comparator: Placebo | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Active Comparator: Duloxetine (60 mg) | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) |
| Event | Placebo Comparator: Placebo | Active Comparator: Duloxetine (60 mg) |
|---|---|---|
| Elevated Heart RateCardiac disorders | 2/3 | 2/4 |
| Elevated Blood PressureCardiac disorders | 2/3 | 2/4 |
| MigraineVascular disorders | 1/3 | 0/4 |
| Age, Categorical(Participants) | Placebo Comparator: Placebo | Active Comparator: Duloxetine | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 4 | 8 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Years) | Placebo Comparator: Placebo | Active Comparator: Duloxetine | Total |
|---|---|---|---|
| Mean | 38 ± 13.08 | 41.5 ± 13.11 | 39.75 ± 11.07 |
| Sex: Female, Male(Participants) | Placebo Comparator: Placebo | Active Comparator: Duloxetine | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 4 | 3 | 7 |
| Race (NIH/OMB)(Participants) | Placebo Comparator: Placebo | Active Comparator: Duloxetine | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 2 | 4 | 6 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Placebo Comparator: Placebo | Active Comparator: Duloxetine | Total |
|---|---|---|---|
| United States | 4 | 4 | 8 |
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Craig Rush