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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Basic Science
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
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.
  • Drug: Methamphetamine
    In each arm, subjects will receive doses of methamphetamine.
    Other names:
    • Metamfetamine
  • Drug: Methylphenidate
    In each arm, subjects will receive methylphenidate capsules.
    Other names:
    • Metadate┬«
  • Drug: Placebo oral capsule
    In each arm, subjects will receive placebo capsules.
    Other names:
    • Lactose
Active Comparator
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.
  • Drug: Methamphetamine
    In each arm, subjects will receive doses of methamphetamine.
    Other names:
    • Metamfetamine
  • Drug: Methylphenidate
    In each arm, subjects will receive methylphenidate capsules.
    Other names:
    • Metadate┬«
  • Drug: Placebo oral capsule
    In each arm, subjects will receive placebo capsules.
    Other names:
    • Lactose
  • Drug: Duloxetine
    Subjects will receive duloxetine capsules in the duloxetine arm.
    Other names:
    • Cymbalta┬«

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky Medical Center
Lexington, Kentucky 40536
Contact:
Craig R Rush, Ph.D.
859-257-5388
crush2@email.uky.edu

University of Kentucky
Lexington, Kentucky 40507
Contact:
Wagner Frances, RN
859-257-5388

More Details

NCT ID
NCT04178993
Status
Recruiting
Sponsor
Craig Rush

Study Contact

Frances Wagner, RN
(859) 257-5388
fpwagn2@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.