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

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Drug: Alcohol
* Drug: Placebos
* Drug: Duloxetine
* Drug: Methylphenidate


Participation Criteria
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Eligibility Criteria
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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 no contraindications/allergies to duloxetine or methylphenidate

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Subjects will receive oral placebo capsules one time daily. | Drug: Alcohol<br>* In each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.<br>Drug: Placebos<br>* Subjects will receive placebo capsules.<br>Drug: Methylphenidate<br>* Subjects will receive methylphenidate capsules.<br>|
| Experimental: Low Dose Duloxetine<br>Subjects will receive 30 mg oral duloxetine one time daily. | Drug: Alcohol<br>* In each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.<br>Drug: Duloxetine<br>* Subjects will receive duloxetine capsules.<br>Drug: Methylphenidate<br>* Subjects will receive methylphenidate capsules.<br>|
| Experimental: High Dose Duloxetine<br>Subjects will receive 60 mg oral duloxetine one time daily. | Drug: Alcohol<br>* In each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.<br>Drug: Duloxetine<br>* Subjects will receive duloxetine capsules.<br>Drug: Methylphenidate<br>* Subjects will receive methylphenidate capsules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reinforcing Effects | The reinforcing effects of alcohol will be determined using a self-administration procedure in which subjects choose to take previously sampled doses. Reinforcing effects are measured during maintenance on placebo, duloxetine and methylphenidate. | After at least six days of placebo, duloxetine or methylphenidate maintenance | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scales of Alcohol Effects | Subjects will complete measures using visual analog scales rated from 0-100 to report alcohol effects during three sessions while they are admitted to the inpatient unit. These items will ask about alcohol effects. Higher scores indicate greater effects. | 4 sessions over approximately 4 weeks of study participation | 
| Breath Alcohol Level | Breath alcohol level will be recorded during three sessions while subjects are admitted to the inpatient unit. Breath alcohol level will be recorded in percent. | 4 sessions over approximately 4 weeks of study participation | 
| Systolic blood pressure | Systolic blood pressure will be recorded during three sessions while subjects are admitted to the inpatient unit. Systolic blood pressure will be recorded in mmHg. | 4 sessions over approximately 4 weeks of study participation | 
| Diastolic blood pressure | Diastolic blood pressure will be recorded during three sessions while subjects are admitted to the inpatient unit. Diastolic blood pressure will be recorded in mmHg. | 4 sessions over approximately 4 weeks of study participation | 
| Heart rate | Heart rate will be recorded during three sessions while subjects are admitted to the inpatient unit. Heart rate will be recorded in beats per minute. | 4 sessions over approximately 4 weeks of study participation |