CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 19 enrolled / 19 target
Drug / intervention
Alcohol +4 moredrug
Likely dose
Duloxetine (60 MG)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03575403
NCT03575403Phase 1CompletedUpdate Overdue (0.2/mo)Completion was 39mo ago
CompareCT.gov

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

Craig Rush·interventional·Posted Jul 2, 2018·Updated Jun 9, 2026

In Brief

A Phase 1 clinical trial evaluating Alcohol, Placebos, and 3 other interventions for Alcohol Use Disorder. Completed, enrolled 19 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Use Disorder
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJul 2, 2018
Enrollment StartSep 1, 2018
Primary CompletionMar 15, 2023
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 8 years ago

Arms & Interventions

Placeboplacebo_comparator

Subjects received oral placebo capsules one time daily.

Drug: AlcoholDrug: PlacebosDrug: 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

Alcoholdrug

In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.

Placebosdrug

Subjects will receive oral placebo capsules.

Duloxetine (60 MG)drug

Subjects will receive 60-mg of oral duloxetine capsules.

Methylphenidatedrug

Subjects will receive methylphenidate capsules.

Duloxetine (30 MG)drug

Subjects will receive 30-mg of oral duloxetine capsules.