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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-05-05

Brief Summary

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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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Detailed Description

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Conditions

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Methamphetamine Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Placebo Comparator: Placebo

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.

Group Type PLACEBO_COMPARATOR

Methamphetamine

Intervention Type DRUG

In each arm, subjects will receive doses of methamphetamine.

Methylphenidate

Intervention Type DRUG

In each arm, subjects will receive methylphenidate capsules.

Placebo oral capsule

Intervention Type DRUG

In each arm, subjects will receive placebo capsules.

Active Comparator: Duloxetine

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.

Group Type ACTIVE_COMPARATOR

Methamphetamine

Intervention Type DRUG

In each arm, subjects will receive doses of methamphetamine.

Methylphenidate

Intervention Type DRUG

In each arm, subjects will receive methylphenidate capsules.

Placebo oral capsule

Intervention Type DRUG

In each arm, subjects will receive placebo capsules.

Duloxetine

Intervention Type DRUG

Subjects will receive duloxetine capsules in the duloxetine arm.

Interventions

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Methamphetamine

In each arm, subjects will receive doses of methamphetamine.

Intervention Type DRUG

Methylphenidate

In each arm, subjects will receive methylphenidate capsules.

Intervention Type DRUG

Placebo oral capsule

In each arm, subjects will receive placebo capsules.

Intervention Type DRUG

Duloxetine

Subjects will receive duloxetine capsules in the duloxetine arm.

Intervention Type DRUG

Other Intervention Names

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Metamfetamine Metadate® Lactose Cymbalta®

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes