Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate)
Purpose
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.
Condition
- Alcohol Use Disorder
Eligibility
- Eligible Ages
- Between 21 Years and 55 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
- no contraindications/allergies to duloxetine or methylphenidate
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial Assignment
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Placebo Comparator Placebo |
Subjects will receive oral placebo capsules one time daily. |
|
Experimental Low Dose Duloxetine |
Subjects will receive 30 mg oral duloxetine one time daily. |
|
Experimental High Dose Duloxetine |
Subjects will receive 60 mg oral duloxetine one time daily. |
|
Recruiting Locations
More Details
- NCT ID
- NCT03575403
- Status
- Completed
- Sponsor
- Craig Rush