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Purpose

This study will evaluate the behavioral effects of alcohol during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods.

Condition

Eligibility

Eligible Ages
Between 21 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Criteria


Inclusion Criteria:

- able to speak/read English

- not seeking treatment at the time of the study

- one binge drinking episode (5+/4+ standard alcoholic drinks per drinking session for
men and women, respectively) in the past 30 days

- recent alcohol use verified by ethyl glucuronide positive urine, as well as
fulfillment of DSM-5 diagnostic criteria for alcohol use disorder

- ECG within normal limits

- otherwise healthy

- body mass index of 19-35

- females using an effective form of birth control and not pregnant or breast feeding

- judged by the medical staff to be psychiatrically and physically healthy

- able to abstain from alcohol for 12 hours prior to session

- no contraindications/allergies to duloxetine or methylphenidate

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 		Subjects will receive oral placebo capsules one time daily.
  • Drug: Alcohol
    In each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
  • Drug: Placebos
    Subjects will receive placebo capsules.
  • Drug: Methylphenidate
    Subjects will receive methylphenidate capsules.
Experimental
Low Dose Duloxetine 		Subjects will receive 30 mg oral duloxetine one time daily.
  • Drug: Alcohol
    In each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
  • Drug: Duloxetine
    Subjects will receive duloxetine capsules.
  • Drug: Methylphenidate
    Subjects will receive methylphenidate capsules.
Experimental
High Dose Duloxetine 		Subjects will receive 60 mg oral duloxetine one time daily.
  • Drug: Alcohol
    In each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
  • Drug: Duloxetine
    Subjects will receive duloxetine capsules.
  • Drug: Methylphenidate
    Subjects will receive methylphenidate capsules.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40511
Contact:
Frances Wagner, RN
859-257-5388
fpwagn2@uky.edu

More Details

NCT ID
NCT03575403
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.