Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DA047391 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Comparator: Placebo | Placebo Comparator | 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. |
|
| Active Comparator: Duloxetine | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methamphetamine | Drug | In each arm, subjects will receive doses of methamphetamine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Daily over approximately 1 week of inpatient stay. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40507 | United States | ||
| University of Kentucky Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. Methamphetamine: In each arm, subjects will receive doses of methamphetamine. Methylphenidate: In each arm, subjects will receive methylphenidate capsules. Placebo oral capsule: In each arm, subjects will receive placebo capsules. |
| FG001 | 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. Methamphetamine: In each arm, subjects will receive doses of methamphetamine. Methylphenidate: In each arm, subjects will receive methylphenidate capsules. Placebo oral capsule: In each arm, subjects will receive placebo capsules. Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Methamphetamine: In each arm, subjects will receive doses of methamphetamine. Methylphenidate: In each arm, subjects will receive methylphenidate capsules. Placebo oral capsule: In each arm, subjects will receive placebo capsules. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | Trials Completed | Following at least 4 days of maintenance on placebo during inpatient admission, up to 1 week |
|
Assessed during 4.5 weeks of inpatient study.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Methamphetamine: In each arm, subjects will receive doses of methamphetamine. Methylphenidate: In each arm, subjects will receive methylphenidate capsules. Placebo oral capsule: In each arm, subjects will receive placebo capsules. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Heart Rate | Cardiac disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Craig Rush, Ph.D. | University of Kentucky | 8592575388 | crush2@uky.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 8, 2019 | Nov 15, 2022 | Prot_SAP_ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008694 | Methamphetamine |
| D008774 | Methylphenidate |
| D007785 | Lactose |
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Methylphenidate | Drug | In each arm, subjects will receive methylphenidate capsules. |
|
|
| Placebo oral capsule | Drug | In each arm, subjects will receive placebo capsules. |
|
|
| Duloxetine | Drug | Subjects will receive duloxetine capsules in the duloxetine arm. |
|
|
| Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week |
| 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Daily over approximately 1 week of inpatient stay. |
| 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. | 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). | 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). | 4 sessions over approximately 4.5 weeks |
| Lexington |
| Kentucky |
| 40536 |
| United States |
| BG001 | 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. Methamphetamine: In each arm, subjects will receive doses of methamphetamine. Methylphenidate: In each arm, subjects will receive methylphenidate capsules. Placebo oral capsule: In each arm, subjects will receive placebo capsules. Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Active Comparator: Duloxetine (60 mg) | 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. Methamphetamine: In each arm, subjects will receive doses of methamphetamine. Methylphenidate: In each arm, subjects will receive methylphenidate capsules. Placebo oral capsule: In each arm, subjects will receive placebo capsules. Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm. |
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | Trials Completed | Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | Trials Completed | Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | Trials Completed | Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | Beats Per Minute | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | Beats Per Minute | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | Beats Per Minute | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | Beats Per Minute | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | Millimeter of Mercury | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | Millimeter of Mercury | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | Millimeter of Mercury | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | Millimeter of Mercury | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | Millimeter of Mercury | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | Millimeter of Mercury | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | Millimeter of Mercury | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | Millimeter of Mercury | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | Degrees Fahrenheit | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | Degrees Fahrenheit | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | Degrees Fahrenheit | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | Degrees Fahrenheit | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Millimeters | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Millimeters | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Millimeters | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Millimeters | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Millimeters | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Millimeters | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Millimeters | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Millimeters | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Millimeters | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Millimeters | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Millimeters | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Millimeters | Daily over approximately 1 week of inpatient stay. |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | Proportion of Responses | 12 sessions over approximately 4.5 weeks |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | Units on a Scale | 4 times over approximately 4.5 weeks |
|
|
|
| Other Pre-specified | 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). | Posted | Mean | Standard Deviation | log(k) | 4 sessions over approximately 4.5 weeks |
|
|
|
| Other Pre-specified | 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). | Posted | Mean | Standard Deviation | log(k) | 4 sessions over approximately 4.5 weeks |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | Active Comparator: Duloxetine (60 mg) | 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. Methamphetamine: In each arm, subjects will receive doses of methamphetamine. Methylphenidate: In each arm, subjects will receive methylphenidate capsules. Placebo oral capsule: In each arm, subjects will receive placebo capsules. Duloxetine: Subjects will receive duloxetine capsules in the duloxetine arm. | 0 | 4 | 0 | 4 | 2 | 4 |
| Elevated Blood Pressure | Cardiac disorders | Non-systematic Assessment |
|
| Migraine | Vascular disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Organic Chemicals |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| Methamphetamine (20mg) |
|
| Methamphetamine (20mg) |
|
| Methamphetamine (20mg) |
|
| Methamphetamine (20 mg) |
|
| Methamphetamine (20 mg) |
|
| Methamphetamine (20 mg) |
|
| Methamphetamine (20 mg) |
|
| Methamphetamine (20 mg) |
|
| Methamphetamine (20 mg) |
|
| Methamphetamine (20 mg) |
|
| Methamphetamine (20 mg) |
|
| Methamphetamine (20 mg) |
|
| Methamphetamine (20 mg) |
|
| Methamphetamine (20 mg) |
|
| Methamphetamine (20 mg) |
|
| Methamphetamine (20 mg) |
|
| Methamphetamine (20 mg) |
|
| Methamphetamine (20 mg) |
|
| Methamphetamine (20 mg) |
|
| Nervous/Anxious |
|
| Nauseated/Queasy/Sick to Stomach |
|
| Talkative/Friendly |
|
| Irregular/Racing Heartbeat |
|
| Euphoric |
|
| Shaky/Jittery |
|
| Active/Alert/Energetic |
|
| Will Pay For |
|
| Will Take Again |
|
| Performance Improved |
|
| Performance Impaired |
|
| Stimulated |
|
| Like Drug |
|
| Rush |
|
| High |
|
| Good Effects |
|
| Bad Effects |
|
| Any Effect |
|
| Nervous/Anxious |
|
| Nauseated/Queasy/Sick to Stomach |
|
| Talkative/Friendly |
|
| Irregular/Racing Heartbeat |
|
| Euphoric |
|
| Shaky/Jittery |
|
| Active/Alert/Energetic |
|
| Will Pay For |
|
| Will Take Again |
|
| Performance Improved |
|
| Performance Impaired |
|
| Stimulated |
|
| Like Drug |
|
| Rush |
|
| High |
|
| Good Effects |
|
| Bad Effects |
|
| Any Effect |
|
| Nervous/Anxious |
|
| Nauseated/Queasy/Sick to Stomach |
|
| Talkative/Friendly |
|
| Irregular/Racing Heartbeat |
|
| Euphoric |
|
| Shaky/Jittery |
|
| Active/Alert/Energetic |
|
| Will Pay For |
|
| Will Take Again |
|
| Performance Improved |
|
| Performance Impaired |
|
| Stimulated |
|
| Like Drug |
|
| Rush |
|
| High |
|
| Good Effects |
|
| Bad Effects |
|
| Any Effect |
|
| Nervous/Anxious |
|
| Nauseated/Queasy/Sick to Stomach |
|
| Talkative/Friendly |
|
| Irregular/Racing Heartbeat |
|
| Euphoric |
|
| Shaky/Jittery |
|
| Active/Alert/Energetic |
|
| Will Pay For |
|
| Will Take Again |
|
| Performance Improved |
|
| Performance Impaired |
|
| Stimulated |
|
| Like Drug |
|
| Rush |
|
| High |
|
| Good Effects |
|
| Bad Effects |
|
| Any Effect |
|
| Nervous/Anxious |
|
| Nauseated/Queasy/Sick to Stomach |
|
| Talkative/Friendly |
|
| Irregular/Racing Heartbeat |
|
| Euphoric |
|
| Shaky/Jittery |
|
| Active/Alert/Energetic |
|
| Will Pay For |
|
| Will Take Again |
|
| Performance Improved |
|
| Performance Impaired |
|
| Stimulated |
|
| Like Drug |
|
| Rush |
|
| High |
|
| Good Effects |
|
| Bad Effects |
|
| Any Effect |
|
| Nervous/Anxious |
|
| Nauseated/Queasy/Sick to Stomach |
|
| Talkative/Friendly |
|
| Irregular/Racing Heartbeat |
|
| Euphoric |
|
| Shaky/Jittery |
|
| Active/Alert/Energetic |
|
| Will Pay For |
|
| Will Take Again |
|
| Performance Improved |
|
| Performance Impaired |
|
| Stimulated |
|
| Like Drug |
|
| Rush |
|
| High |
|
| Good Effects |
|
| Bad Effects |
|
| Any Effect |
|
| Nervous/Anxious |
|
| Nauseated/Queasy/Sick to Stomach |
|
| Talkative/Friendly |
|
| Irregular/Racing Heartbeat |
|
| Euphoric |
|
| Shaky/Jittery |
|
| Active/Alert/Energetic |
|
| Will Pay For |
|
| Will Take Again |
|
| Performance Improved |
|
| Performance Impaired |
|
| Stimulated |
|
| Like Drug |
|
| Rush |
|
| High |
|
| Good Effects |
|
| Bad Effects |
|
| Any Effect |
|
| Nervous/Anxious |
|
| Nauseated/Queasy/Sick to Stomach |
|
| Talkative/Friendly |
|
| Irregular/Racing Heartbeat |
|
| Euphoric |
|
| Shaky/Jittery |
|
| Active/Alert/Energetic |
|
| Will Pay For |
|
| Will Take Again |
|
| Performance Improved |
|
| Performance Impaired |
|
| Stimulated |
|
| Like Drug |
|
| Rush |
|
| High |
|
| Good Effects |
|
| Bad Effects |
|
| Any Effect |
|
| Nervous/Anxious |
|
| Nauseated/Queasy/Sick to Stomach |
|
| Talkative/Friendly |
|
| Irregular/Racing Heartbeat |
|
| Euphoric |
|
| Shaky/Jittery |
|
| Active/Alert/Energetic |
|
| Will Pay For |
|
| Will Take Again |
|
| Performance Improved |
|
| Performance Impaired |
|
| Stimulated |
|
| Like Drug |
|
| Rush |
|
| High |
|
| Good Effects |
|
| Bad Effects |
|
| Any Effect |
|
| Nervous/Anxious |
|
| Nauseated/Queasy/Sick to Stomach |
|
| Talkative/Friendly |
|
| Irregular/Racing Heartbeat |
|
| Euphoric |
|
| Shaky/Jittery |
|
| Active/Alert/Energetic |
|
| Will Pay For |
|
| Will Take Again |
|
| Performance Improved |
|
| Performance Impaired |
|
| Stimulated |
|
| Like Drug |
|
| Rush |
|
| High |
|
| Good Effects |
|
| Bad Effects |
|
| Any Effect |
|
| Nervous/Anxious |
|
| Nauseated/Queasy/Sick to Stomach |
|
| Talkative/Friendly |
|
| Irregular/Racing Heartbeat |
|
| Euphoric |
|
| Shaky/Jittery |
|
| Active/Alert/Energetic |
|
| Will Pay For |
|
| Will Take Again |
|
| Performance Improved |
|
| Performance Impaired |
|
| Stimulated |
|
| Like Drug |
|
| Rush |
|
| High |
|
| Good Effects |
|
| Bad Effects |
|
| Any Effect |
|
| Nervous/Anxious |
|
| Nauseated/Queasy/Sick to Stomach |
|
| Talkative/Friendly |
|
| Irregular/Racing Heartbeat |
|
| Euphoric |
|
| Shaky/Jittery |
|
| Active/Alert/Energetic |
|
| Will Pay For |
|
| Will Take Again |
|
| Performance Improved |
|
| Performance Impaired |
|
| Stimulated |
|
| Like Drug |
|
| Rush |
|
| High |
|
| Good Effects |
|
| Bad Effects |
|
| Any Effect |
|
| Methylphenidate (40mg) |
|
| Methylphenidate (60mg) |
|
| Methylphenidate (40 mg) |
|
| Methylphenidate (60 mg) |
|
| Methylphenidate (40mg) |
|
| Methylphenidate (60mg) |
|
| Methylphenidate (40mg) |
|
| Methylphenidate (60mg) |
|