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Alcohol for Alcoholism (BED IN 36 Trial)

Phase 1
Waitlist Available
Led By Craig Rush, PhD
Research Sponsored by Craig Rush
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 sessions over approximately 4 weeks of study participation
Awards & highlights

Summary

This trial will study the effects of alcohol while taking placebo, duloxetine, methylphenidate, and a combination of duloxetine and methylphenidate.

Eligible Conditions
  • Alcoholism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after at least six days of placebo, duloxetine or methylphenidate maintenance
This trial's timeline: 3 weeks for screening, Varies for treatment, and after at least six days of placebo, duloxetine or methylphenidate maintenance for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reinforcing Effects
Secondary outcome measures
Breath Alcohol Level
Diastolic blood pressure
Heart rate
+2 more

Side effects data

From 2017 Phase 2 trial • 17 Patients • NCT01779024
59%
Increased Appetite
41%
Somnolence
35%
Euphoric mood
29%
Fatigue
12%
Memory impairment
12%
Hyperhidrosis
12%
Dizziness
12%
Nausea
6%
Feeling hot
6%
Flushing
6%
Headache
6%
Decreased appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ghrelin
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Dose DuloxetineExperimental Treatment3 Interventions
Subjects will receive 30 mg oral duloxetine one time daily.
Group II: High Dose DuloxetineExperimental Treatment3 Interventions
Subjects will receive 60 mg oral duloxetine one time daily.
Group III: PlaceboPlacebo Group3 Interventions
Subjects will receive oral placebo capsules one time daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylphenidate
2014
Completed Phase 4
~431850
Alcohol
2008
Completed Phase 3
~2000
Duloxetine
2011
Completed Phase 4
~4170

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Craig RushLead Sponsor
5 Previous Clinical Trials
536 Total Patients Enrolled
1 Trials studying Alcoholism
444 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
815 Previous Clinical Trials
1,159,852 Total Patients Enrolled
428 Trials studying Alcoholism
778,280 Patients Enrolled for Alcoholism
Craig Rush, PhDPrincipal Investigator - University of Kentucky
Commonwealth Regional Specialty Hospital, Medical Center, The
Rush Medical College Of Rush University (Medical School)
Franciscan Medical Ctr-Dayton (Residency)
1 Previous Clinical Trials
40 Total Patients Enrolled
~3 spots leftby Jul 2025
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