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

Alcohol Use Disorder Clinical Trial

— BED IN 36  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03575403
• Other study ID #: 44796
• Secondary ID: R01AA026255
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2018
• Est. completion date: March 15, 2023

Study information

• Verified date: July 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• Alcohol
In each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
• Placebos
Subjects will receive placebo capsules.
• Duloxetine
Subjects will receive duloxetine capsules.
• Methylphenidate
Subjects will receive methylphenidate capsules.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Craig Rush	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After at least six days of placebo, duloxetine or methylphenidate maintenance
Secondary	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.	4 sessions over approximately 4 weeks of study participation
Secondary	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.	4 sessions over approximately 4 weeks of study participation
Secondary	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.	4 sessions over approximately 4 weeks of study participation
Secondary	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.	4 sessions over approximately 4 weeks of study participation
Secondary	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.	4 sessions over approximately 4 weeks of study participation