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

Craig Rush

Status and phase: Completed; Phase 1

Conditions: Methamphetamine Use Disorder

Treatments: Drug: Methylphenidate; Drug: Methamphetamine; Drug: Placebo oral capsule; Drug: Duloxetine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04178993

R01DA047391 (U.S. NIH Grant/Contract)

BED(IN):40

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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8 participants in 2 patient groups, including a placebo group

Placebo Comparator: Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo oral capsule

Drug: Methamphetamine

Drug: Methylphenidate

Active Comparator: Duloxetine

Active Comparator group

Description:

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.

Treatment:

Drug: Duloxetine

Drug: Placebo oral capsule

Drug: Methamphetamine

Drug: Methylphenidate