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

NCT03575403 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 44796R01AA026255
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

• Reinforcing Effects (Pre-Alcohol Dose Consumption)

  The reinforcing effects of alcohol will be determined using a alcohol purchase task procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent "alpha", which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected prior to consumption of the alcohol dose. There is no minimum or maximum value.

  Measured at each methylphenidate dose-level over approximately four weeks of participation.

• Reinforcing Effects (Post-Alcohol Dose Consumption)

  The reinforcing effects of alcohol will be determined using a alcohol purchase procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent "alpha", which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected following consumption of the alcohol dose. There is no minimum or maximum value.

  Measured at each methylphenidate dose-level over approximately four weeks of participation.

Secondary Outcomes (8)

• Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance.

  Measured at each methylphenidate dose-level over approximately four weeks of participation.

• Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance.

  Measured at each methylphenidate dose-level over approximately four weeks of participation.

• Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance.

  Measured at each methylphenidate dose-level over approximately four weeks of participation.

• Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance.

  Measured at each methylphenidate dose-level over approximately four weeks of participation.

• Breath Alcohol Level

  Measured at each methylphenidate dose-level over approximately four weeks of participation.

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Subjects received oral placebo capsules one time daily.

Drug: Alcohol; Drug: Placebos; Drug: Methylphenidate

Duloxetine (60 MG)

EXPERIMENTAL

Subjects received 60 mg of oral duloxetine one time daily.

Drug: Duloxetine (60 MG)

Duloxetine (30 MG)

EXPERIMENTAL

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.

Drug: Duloxetine (30 MG)

Interventions

Alcohol 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.

Placebo

Placebos DRUG

Subjects will receive oral placebo capsules.

Placebo

Duloxetine (60 MG) DRUG

Subjects will receive 60-mg of oral duloxetine capsules.

Duloxetine (60 MG)

Methylphenidate DRUG

Subjects will receive methylphenidate capsules.

Placebo

Duloxetine (30 MG) DRUG

Subjects will receive 30-mg of oral duloxetine capsules.

Duloxetine (30 MG)

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Craig Rush: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40511, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol; Duloxetine Hydrochloride; Methylphenidate

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Piperidines

Results Point of Contact

• Title: Dr. Craig R. Rush, Ph.D.
• Organization: University of Kentucky

crush2@uky.edu

8592575388

Study Officials

• Craig Rush, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 2, 2018
• Study Start: September 1, 2018
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)