Phase 1
Completed N=19
Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate)
Source: ClinicalTrials.gov NCT03575403 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Reinforcing Effects (Pre-Alcohol Dose Consumption) — 0.005; .01; 0.007; 0.005 Units on a Theoretical Scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reinforcing Effects (Pre-Alcohol Dose Consumption) |
0.005; .01; 0.007; 0.005; .02; 0.007 | — |
| PRIMARY Reinforcing Effects (Post-Alcohol Dose Consumption) |
0.004; .01; 0.006; 0.005; .01; 0.007 | — |
| SECONDARY Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance. |
15.89; 4.50; 22.00; 0.11; 1.00; 2.00 | — |
| SECONDARY Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance. |
17.44; 10.50; 28.50; 0.22; 1.50; 1.83 | — |
| SECONDARY Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance. |
10.67; 7.50; 20.17; 0.11; 1.00; 2.50 | — |
| SECONDARY Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance. |
12.67; 5.50; 17.17; 0.11; 1.00; 1.17 | — |
| SECONDARY Breath Alcohol Level |
0.026; 0.031; 0.029; 0.024; 0.031; 0.042 | — |
| SECONDARY Systolic Blood Pressure |
125.00; 129.00; 124.00; 126.67; 140.00; 121.67 | — |
| SECONDARY Diastolic Blood Pressure |
73.56; 82.00; 77.67; 74.00; 88.50; 77.00 | — |
| SECONDARY Heart Rate |
75.89; 66.50; 75.83; 83.44; 80.50; 84.83 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03575403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.