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Completed

NCT Number: NCT04178993

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

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.

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Key information

Conditions

Methamphetamine Use Disorder

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Kentucky, Lexington, Kentucky, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Methamphetamine

Drug

In each arm, subjects will receive doses of methamphetamine.

Other names: Metamfetamine

Methylphenidate

Drug

In each arm, subjects will receive methylphenidate capsules.

Other names: Metadate®

Placebo oral capsule

Drug

In each arm, subjects will receive placebo capsules.

Other names: Lactose

Duloxetine

Drug

Subjects will receive duloxetine capsules in the duloxetine arm.

Other names: Cymbalta®

Primary outcomes

  1. Reinforcing Effects of Methamphetamine Following Methylphenidate (0 mg; Placebo) Maintenance.

    Time frame: 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).

  2. Reinforcing Effects of Methamphetamine Following Methylphenidate (20 mg) Maintenance.

    Time frame: 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).

  3. Reinforcing Effects of Methamphetamine Following Methylphenidate (40 mg) Maintenance.

    Time frame: 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).

  4. Reinforcing Effects of Methamphetamine Following Methylphenidate (60 mg) Maintenance.

    Time frame: 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 outcomes

  1. Heart Rate After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.

    Time frame: 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)

  2. Heart Rate After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.

    Time frame: 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)

  3. Heart Rate After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.

    Time frame: 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)

  4. Heart Rate After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.

    Time frame: 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)

  5. Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.

    Time frame: 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)

  6. Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.

    Time frame: 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)

  7. Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.

    Time frame: 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)

  8. Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.

    Time frame: 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)

  9. Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.

    Time frame: 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)

  10. Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.

    Time frame: 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)

  11. Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.

    Time frame: 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)

  12. Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.

    Time frame: 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)

  13. Temperature After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.

    Time frame: 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)

  14. Temperature After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.

    Time frame: 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)

  15. Temperature After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.

    Time frame: 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)

  16. Temperature After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.

    Time frame: 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)

  17. Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.

    Time frame: 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.

  18. Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.

    Time frame: 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.

  19. Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.

    Time frame: 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.

  20. Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.

    Time frame: 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.

  21. Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.

    Time frame: 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.

  22. Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.

    Time frame: 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.

  23. Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.

    Time frame: 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.

  24. Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.

    Time frame: 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.

  25. Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.

    Time frame: 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.

  26. Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.

    Time frame: 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.

  27. Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.

    Time frame: 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.

  28. Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.

    Time frame: 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.

Other outcomes

  1. Attentional Bias

    Time frame: 12 sessions over approximately 4.5 weeks

    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.

  2. Snaith-Hamilton-Pleasure Scale to Measure Anhedonia (Inability to Experience Pleasure)

    Time frame: 4 times over approximately 4.5 weeks

    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.

  3. Delay Discounting for Methamphetamine

    Time frame: 4 sessions over approximately 4.5 weeks

    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. Delay Discounting for Money

    Time frame: 4 sessions over approximately 4.5 weeks

    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).

Sponsors and collaborators

Lead sponsor

Craig Rush

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 26, 2019
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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