Behavioral Effects of Drugs (Inpatient): 40 [Methamphetamine, Methylphenidate, Duloxetine]

Phase 1

Completed

• Conditions: Methamphetamine Use Disorder
• Interventions: Drug: Methamphetamine; Drug: Methylphenidate; Drug: Placebo oral capsule; Drug: Duloxetine

• Registration Number: NCT04178993
• Lead Sponsor: Craig Rush

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-09
• Study Start: 2019-09-01
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-26
• Primary Completion: 2021-05-05
• Study Completion: 2021-05-05
• Results First Submitted: 2022-09-23
• Status Verified: 2022-12
• Results First Submitted QC: 2022-12-12
• Last Update Submitted: 2022-12-12
• Results First Posted: 2023-01-09
• Last Update Posted: 2023-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• recent use of inhaled (i.e., snorted), smoked or injected methamphetamine

Exclusion Criteria

• Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant.
• Current or past histories of substance use that are deemed by the study physicians to interfere with study completion.
• History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation.
• Females not currently using effective birth control.
• Contraindications to methamphetamine, methylphenidate, or duloxetine.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator: Placebo	Placebo oral capsule	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	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.
Placebo Comparator: Placebo	Methamphetamine	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.
Placebo Comparator: Placebo	Methylphenidate	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	Methamphetamine	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.
Active Comparator: Duloxetine	Methylphenidate	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.
Active Comparator: Duloxetine	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.

Primary Outcome Measures

Name	Time	Method
Reinforcing Effects of Methamphetamine Following Methylphenidate (0 mg; Placebo) Maintenance.	Following at least 4 days of maintenance on placebo during inpatient admission, up to 1 week	Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have ten opportunities (e.g., trials) to "work" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).
Reinforcing Effects of Methamphetamine Following Methylphenidate (60 mg) Maintenance.	Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week	Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to "work" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).
Reinforcing Effects of Methamphetamine Following Methylphenidate (20 mg) Maintenance.	Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week	Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to "work" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).
Reinforcing Effects of Methamphetamine Following Methylphenidate (40 mg) Maintenance.	Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week	Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement. Subjects sample a dose of methamphetamine (0, 10, or 20 mg) and then have the ten opportunities (e.g., trials) to "work" for a 1/10th of the sampled dose via clicking on a computer mouse (i.e., 10 completed trials is the full sampled dose).

Secondary Outcome Measures

Name	Time	Method
Heart Rate After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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)
Heart Rate After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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)
Heart Rate After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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)
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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)
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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)
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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)
Heart Rate After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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)
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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)
Temperature After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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)
Temperature After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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)
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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)
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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)
Temperature After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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)
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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.
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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.
Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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)
Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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)
Temperature After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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)
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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.
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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.
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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.
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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.
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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.
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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.
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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.
Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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.
Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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.
Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.	Daily over approximately 1 week of inpatient stay.	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.

Trial Locations

Locations (2)

University of Kentucky Medical Center; 🇺🇸 Lexington, Kentucky, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States