Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate)

NCT03575403 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-04-10

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Alcohol

In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.

DRUG

Placebos

Subjects will receive oral placebo capsules.

DRUG

Duloxetine (60 MG)

Subjects will receive 60-mg of oral duloxetine capsules.

DRUG

Methylphenidate

Subjects will receive methylphenidate capsules.

DRUG

Duloxetine (30 MG)

Subjects will receive 30-mg of oral duloxetine capsules.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH
  • Craig Rush

    lead OTHER

Principal Investigators

  • Craig Rush, PhD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2023-03-15
Completion
2023-03-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03575403 on ClinicalTrials.gov