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
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 8
Healthy volunteers: yes

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:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Methamphetamine intervention 2: Methylphenidate intervention 3: Placebo oral capsule intervention 4: Duloxetine
Intervention descriptions: intervention 1: In each arm, subjects will receive doses of methamphetamine. intervention 2: In each arm, subjects will receive methylphenidate capsules. intervention 3: In each arm, subjects will receive placebo capsules. intervention 4: Subjects will receive duloxetine capsules in the duloxetine arm.

Protocol document:
Prot_SAP_ICF_001.pdf: 
Document Coversheet 
 
Study Title: A Novel Drug Combination as a Pharmacotherapeutic for Methamphetamine-Use 
Disorder    
Institution/Site:  
University of Kentucky 
Document (Approval/Update) Date: 
ICF 3/18/21; protocol 7/8/19 
NCT Number: 
NCT04178993 
IRB Number 
51704 
Coversheet created: AWR 
11/11/22 
 
 


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