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

Primary Purpose

Alcohol Use Disorder

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Alcohol

Placebos

Duloxetine

Methylphenidate

About this trial

This is an interventional basic science trial for Alcohol Use Disorder

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Low Dose Duloxetine

High Dose Duloxetine

Arm Description

Subjects will receive oral placebo capsules one time daily.

Subjects will receive 30 mg oral duloxetine one time daily.

Subjects will receive 60 mg oral duloxetine one time daily.

Outcomes

Primary Outcome Measures

Reinforcing Effects

The reinforcing effects of alcohol will be determined using a self-administration procedure in which subjects choose to take previously sampled doses. Reinforcing effects are measured during maintenance on placebo, duloxetine and methylphenidate.

Secondary Outcome Measures

Visual Analog Scales of Alcohol Effects

Subjects will complete measures using visual analog scales rated from 0-100 to report alcohol effects during three sessions while they are admitted to the inpatient unit. These items will ask about alcohol effects. Higher scores indicate greater effects.

Breath Alcohol Level

Breath alcohol level will be recorded during three sessions while subjects are admitted to the inpatient unit. Breath alcohol level will be recorded in percent.

Systolic blood pressure

Systolic blood pressure will be recorded during three sessions while subjects are admitted to the inpatient unit. Systolic blood pressure will be recorded in mmHg.

Diastolic blood pressure

Diastolic blood pressure will be recorded during three sessions while subjects are admitted to the inpatient unit. Diastolic blood pressure will be recorded in mmHg.

Heart rate

Heart rate will be recorded during three sessions while subjects are admitted to the inpatient unit. Heart rate will be recorded in beats per minute.

Full Information

NCT ID

NCT03575403

First Posted

June 22, 2018

Last Updated

July 10, 2023

Sponsor

Craig Rush

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT03575403

Brief Title

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

Acronym

BED IN 36

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

September 1, 2018 (Actual)

Primary Completion Date

March 15, 2023 (Actual)

Study Completion Date

March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Craig Rush

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects will receive oral placebo capsules one time daily.

Arm Title

Low Dose Duloxetine

Arm Type

Experimental

Arm Description

Subjects will receive 30 mg oral duloxetine one time daily.

Arm Title

High Dose Duloxetine

Arm Type

Experimental

Arm Description

Subjects will receive 60 mg oral duloxetine one time daily.

Intervention Type

Drug

Intervention Name(s)

Alcohol

Intervention Description

In each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.

Intervention Type

Drug

Intervention Name(s)

Placebos

Intervention Description

Subjects will receive placebo capsules.

Intervention Type

Drug

Intervention Name(s)

Duloxetine

Intervention Description

Subjects will receive duloxetine capsules.

Intervention Type

Drug

Intervention Name(s)

Methylphenidate

Intervention Description

Subjects will receive methylphenidate capsules.

Primary Outcome Measure Information:

Title

Reinforcing Effects

Description

Time Frame

After at least six days of placebo, duloxetine or methylphenidate maintenance

Secondary Outcome Measure Information:

Title

Visual Analog Scales of Alcohol Effects

Description

Time Frame