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

Methamphetamine Use Disorder Clinical Trial

Official title:

A Novel Drug Combination as a Pharmacotherapeutic for Methamphetamine-Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04178993
• Other study ID #: BED(IN):40
• Secondary ID: R01DA047391
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2019
• Est. completion date: May 5, 2021

Study information

• Verified date: December 2022
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 5, 2021
• Est. primary completion date: May 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Methamphetamine Use Disorder

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky
United States	University of Kentucky Medical Center	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Craig Rush	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	12 sessions over approximately 4.5 weeks
Other	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
Other	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
Other	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
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).	Following at least 4 days of maintenance on placebo during inpatient admission, up to 1 week
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).	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).	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).	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Daily over approximately 1 week of inpatient stay.