NCT03575403

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

A Novel Drug Combination for Alcohol-Use Disorders: A Human Laboratory Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Craig Rush · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Prior to the outbreak of the COVID-19 virus and subsequent work-from-home orders from the state of Kentucky government, participants completed five overnight sessions at theUniversity of Kentucky Inpatient Research Unit in the medical center. The protocol was then changed to have five sessions scheduled to be completed on an outpatient basis in the late afternoon/early evening. This protocol change was enacted following the resumption of research in the fall of 2020. For both the inpatient and outpatient portions of this protocol, the first of these sessions was a practice session to familiarize participants with experimental procedures. The subsequent four experimental sessions were conducted following one-week maintenance on a methylphenidate dose (0, 20, 40, and 60 mg/day; within-subjects factor) over the span of four weeks. Participants were assigned to either an active duloxetine arm (60 mg/day) or placebo arm (between-subjects factor) also for the span of four weeks. The outcome measures collected were the same for both the inpatient and outpatient aspects of the study. Subjects received 30 mg of oral duloxetine one time daily. Note: only 2 subjects were enrolled in this arm prior to the arm being removed in the summer of 2020. Data from this arm will not be reported in order to avoid any HIPAA violation due to the small number of subjects in this arm. Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, visual inspection of their data revealed that their data was not appreciably different from participants in the 60 mg/day duloxetine arm. Therefore, we have added the data from these two participants to the 60 mg/day duloxetine arm for all reported data.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-09-01
• Primary completion: 2023-03-15
• Completion: 2023-03-15
• First posted: 2018-07-02
• Last updated: 2025-04-10
• Results posted: 2025-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study