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

NCT ID: NCT03575403

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2023-03-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Subjects received oral placebo capsules one time daily.

Group Type: PLACEBO_COMPARATOR

Alcohol

Intervention Type: DRUG

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

Placebos

Intervention Type: DRUG

Subjects will receive oral placebo capsules.

Methylphenidate

Intervention Type: DRUG

Subjects will receive methylphenidate capsules.

Duloxetine (60 MG)

Subjects received 60 mg of oral duloxetine one time daily.

Group Type: EXPERIMENTAL

Duloxetine (60 MG)

Intervention Type: DRUG

Subjects will receive 60-mg of oral duloxetine capsules.

Duloxetine (30 MG)

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.

Group Type: EXPERIMENTAL

Duloxetine (30 MG)

Intervention Type: DRUG

Subjects will receive 30-mg of oral duloxetine capsules.

Interventions

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.

Intervention Type: DRUG

Placebos

Subjects will receive oral placebo capsules.

Intervention Type: DRUG

Duloxetine (60 MG)

Subjects will receive 60-mg of oral duloxetine capsules.

Intervention Type: DRUG

Methylphenidate

Subjects will receive methylphenidate capsules.

Intervention Type: DRUG

Duloxetine (30 MG)

Subjects will receive 30-mg of oral duloxetine capsules.

Intervention Type: DRUG

Eligibility 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

Exclusion Criteria

• Not under 21 years of age or over 55 years of age
• no contraindications/allergies to alcohol, duloxetine, or methylphenidate

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Craig Rush

OTHER

Sponsor Role: lead

Responsible Party

Craig Rush

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Craig Rush, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01AA026255

Identifier Type: NIH

Identifier Source: secondary_id

View Link

44796

Identifier Type: -

Identifier Source: org_study_id