Clinical trial NCT04178993: Behavioral Effects of Drugs (Inpatient): 40 [Methamphetamine, Methylphenidate, Duloxetine]
Official title: A Novel Drug Combination as a Pharmacotherapeutic for Methamphetamine-Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Methamphetamine Use Disorder
Keywords: Methamphetamine
Methylphenidate
Duloxetine Hydrochloride
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Serotonin and Noradrenaline Reuptake Inhibitors
Membrane Transport Modulators
Neurotransmitter Agents
Dopamine Agents
Molecular Mechanisms of Pharmacological Action
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Antidepressive Agents
Psychotropic Drugs
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-11-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reinforcing Effects of Methamphetamine Following Methylphenidate (0 mg; Placebo) Maintenance.
timeFrame: Following at least 4 days of maintenance on placebo during inpatient admission, up to 1 week
measure: Reinforcing Effects of Methamphetamine Following Methylphenidate (20 mg) Maintenance.
timeFrame: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week
measure: Reinforcing Effects of Methamphetamine Following Methylphenidate (40 mg) Maintenance.
timeFrame: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week
measure: Reinforcing Effects of Methamphetamine Following Methylphenidate (60 mg) Maintenance.
timeFrame: Following at least 4 days of maintenance on drug during inpatient admission, up to 1 week
Secondary outcomes:
measure: Heart Rate After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Heart Rate After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Heart Rate After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Heart Rate After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Systolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Diastolic Blood Pressure After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Temperature After Methamphetamine Administration Following Methylphenidate (0 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Temperature After Methamphetamine Administration Following Methylphenidate (20 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Temperature After Methamphetamine Administration Following Methylphenidate (40 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Temperature After Methamphetamine Administration Following Methylphenidate (60 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (0 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (0 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (0 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (20 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (20 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (20 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (40 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (40 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (40 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Subjective Effects of Methamphetamine (0 mg) Administration Following Methylphenidate (60 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Subjective Effects of Methamphetamine (10 mg) Administration Following Methylphenidate (60 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
measure: Subjective Effects of Methamphetamine (20 mg) Administration Following Methylphenidate (60 mg) Maintenance.
timeFrame: Daily over approximately 1 week of inpatient stay.
Other outcomes:
measure: Attentional Bias
timeFrame: 12 sessions over approximately 4.5 weeks
measure: Snaith-Hamilton-Pleasure Scale to Measure Anhedonia (Inability to Experience Pleasure)
timeFrame: 4 times over approximately 4.5 weeks
measure: Delay Discounting for Methamphetamine
timeFrame: 4 sessions over approximately 4.5 weeks
measure: Delay Discounting for Money
timeFrame: 4 sessions over approximately 4.5 weeks
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
Study officials:
References: