CompletedPhase 1

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

United States19 participantsStarted 2018-09-01

Plain-language 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.

Who can participate

Age range21 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Reinforcing Effects (Pre-Alcohol Dose Consumption)

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

Reinforcing Effects (Post-Alcohol Dose Consumption)

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

Trial details

NCT IDNCT03575403

SponsorCraig Rush

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-15

Results submitted2024-03-05

View on ClinicalTrials.gov More Alcohol Use Disorder trials