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Completed

NCT Number: NCT03575403

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

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Kentucky

Lexington, Kentucky, 40511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebos

Drug

Subjects will receive oral placebo capsules.

Duloxetine (60 MG)

Drug

Subjects will receive 60-mg of oral duloxetine capsules.

Methylphenidate

Drug

Subjects will receive methylphenidate capsules.

Duloxetine (30 MG)

Drug

Subjects will receive 30-mg of oral duloxetine capsules.

Primary outcomes

  1. Reinforcing Effects (Pre-Alcohol Dose Consumption)

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

    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.

  2. Reinforcing Effects (Post-Alcohol Dose Consumption)

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

    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.

Secondary outcomes

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

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

    Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol

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

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

    Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol

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

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

    Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol

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

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

    Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol

  5. Breath Alcohol Level

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

    Expired air samples for determining breath alcohol level (BAL) will be recorded during four experimental sessions. BALs were recorded as g/dl. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol. Greater values of BAL represent more alcohol absorbed following consumption.

  6. Systolic Blood Pressure

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

    Systolic blood pressure (millimeter of mercury) was recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.

  7. Diastolic Blood Pressure

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

    Diastolic blood pressure (millimeter of mercury) was recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.

  8. Heart Rate

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

    Heart rate (beats per minute) will be recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.

Sponsors and collaborators

Lead sponsor

Craig Rush

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Acronym: BED[IN]:36

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jul 2, 2018
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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